Io sono io, voi non siete un cazzo...

 Dal Marchese del Grillo:

Latest data and analysis on coronavirus (COVID-19) in the UK

 Latest data, very useful site:

https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases

​​Are covid “vaccines” giving people AIDS?

From:

Janie Still

in The Light Paper Distribution

Forwarded from Dr Naomi Wolf

​​Are covid “vaccines” giving people AIDS? Immune system functions are dropping around 5% EACH WEEK in those who were vaccinated

The latest data from the United Kingdom’s PHE Vaccine Surveillance Report suggests that people who have been “fully vaccinated” for the Wuhan coronavirus (Covid-19) are losing about five percent of their immune systems per week.

Doubly injected people between the ages of 40 and 70 have already lost about 40 percent of the immune system capacity from the moment they get injected.

“If this continues then 30-50 year-olds will have 100% immune system degradation, zero viral defence by Christmas and all doubly vaccinated people over 30 will have lost their immune systems by March next year,” reports .

There is no denying, based on the data, that fully vaccinated people now suffer from what appears to be acquired immunodeficiency syndrome, more popularly known as AIDS. Their immune systems are fading away, which many have been warning would be the case.

“People aged 40-69 have already lost 40% of their immune system capability and are losing it progressively at 3.3% to 6.4% per week,”

Interestingly, the worst-off demographic is people aged 40-49, who are suffering total immune system loss in about nine weeks.

Elderly people over the age of 80 last about 20 weeks, while the 50-59 age category only gets about 15 weeks.

“Everybody over 30 will have lost 100% of their entire immune capability (for viruses and certain cancers) within 6 months,” warns The Exposé.

“30-50 year-olds will have lost it by Christmas. These people will then effectively have full blown acquired immunodeficiency syndrome and destroy the NHS (National Health Service).”

Getting a “booster” shot will only speed up the death process

It is not just that the jabs do not provide the claimed amount of protection against the Fauci Flu. The fact of the matter is that they provide no protection at all in the long term and actually destroy a person’s immune system.

“Pfizer originally claimed a 95% efficiency for their vaccine (calculated as in the last column above). The figures above indicate that their figures may well have been correct immediately after vaccination (the younger age groups have had the vaccine for the shortest time),” The Exposé explains.

“But the figures above also show that the vaccines do NOT merely lose efficiency over time down to zero efficiency, they progressively damage the immune system until a negative efficiency is realised. They presently leave anybody over 30 in a worse position than they were before vaccination.”

People who take the Biden “Booster” shots will only accelerate this process by adding even more immune-destroying chemicals to their bodies. The downward spiral will move even faster, in other words, the more shots a person gets.

“If we do nothing about this, it will only get much worse than we ever could have imagined,” wrote one Exposé commenter. “I, for one, appreciate all who have stood against and continue to stand against this tyranny.”

“The spike protein hijacks your mitochondria … forever,” wrote another. “Mitochondria is the heart of your immune system. Essentially, it takes over your immune system. The spike proteins are the bioweapons. Your own immune system becomes a deadly weapon. This is HIV on steroids.”

Others echoed these same sentiments, noting that it is painfully obvious what the agenda is. How anyone could argue with a straight face that this is all for “public health” remains a mystery.

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Deleted UK Government Report Celebrates How Public Loves To “Conform”

 Tyler Durden – Sunday, Oct 24, 2021 – 07:00 AM

Authored by Paul Joseph Watson via Summit News,

A deleted government report exploring how to make the public alter its behavior to accept the new ‘green economy’ reveals how COVID-19 restrictions have created a population with a “deep set reverence” for authority and a “powerful tendency to conform.”

The report was inadvertently published by the British government before being hastily pulled down, but numerous journalists were able to retrieve its contents.

The document explored how to weaponize behavioral psychology to ‘nudge’ the public into supporting measures and adopting behavior without them explicitly knowing they’re being manipulated.

The investigation found that the same techniques the government used to force people into accepting lockdown could be used to make them change their lifestyles in the name of preventing climate change.

Under the heading “principles for successful behaviour,” the paper noted;

“Government statements, actions and laws powerfully shape perceptions of normative and acceptable behaviour. For instance, even with public criticism being high, many still perceived government approval as the yardstick for safe behaviour during COVID-19 ‘we’re allowed to do this now [so must be safe]…’. This reveals, for many, a deep set reverence for legitimate government authority, regardless of one’s personal political views.”

While PR stunts such as having officials vaccinated live on television worked to convince people of the narrative, elite hypocrisy (public officials violating lockdown rules) was found to cause significant damage to public trust.

“Perceived hypocrisy can do a lot to undermine efforts to build public engagement and support. This was observed during the COVID-19 pandemic when prominent authority figures broke guidelines, leading to measurable reductions in public compliance as well as shifting attitudes.”

“Green politics has similar deep-seated reputational issues with elite hypocrisy,” notes Breitbart.

“A common feature of climate change summits has been high-profile attendees arriving by private or government jet, a disconnect between word and deed that seems unlikely to vanish in the near term.”

The paper concluded that people can be rather easily “nudged” into changing their behavior in response to government announcements and “have a powerful tendency to conform.”

The investigation also found that even if enforced changes to lifestyle are not wanted by the public, most tend to fall in line with the new status quo rather quickly anyway.

The report was prepared by the Behavioural Insights Team (BIT), a quasi-government body that was part of the effort to use “totalitarian” and “unethical” methods of instilling fear into the population as a means of scaring them into complying with lockdown rules.

A related group, the Scientific Pandemic Insights Group on Behaviours team, warned at the start of the first lockdown that a “substantial number of people still do not feel sufficiently personally threatened [by Covid-19].”

“The perceived level of personal threat needs to be increased among those who are complacent, using hard-hitting emotional messaging,” the group added, leading to numerous lurid propaganda campaigns that exaggerated the threat of COVID to bully the public into total submission.

In summary, the public is largely unthinking, compliant and docile and can be made to go along with just about anything so long as they’re bombarded with the right propaganda.

Wonderful.

https://unshackledminds.com/deleted-uk-government-report-celebrates-how-public-loves-to-conform/

Be careful to vaccinate young people...

 Shocking data from vaccination in young people:

Roberto Mazzoni spiega bene il Green Pass

E' un progetto del WEF e dell'ONU che ci lavorano da tanto tempo. Dovrà essere rinnovato regolarmente. E' esattamente il Sistema di Controllo che vige in Cina"

Il Giornalista espone con estrema chiarezza il progetto dell'élite.

Come lo si spiegherebbe ad un bambino di otto anni.

Ad integrazione ci permettiamo di aggiungere che le auto non dovranno essere solo elettriche, ma a guida autonoma.

Nella mente perversa degli ideatori, tutto dovrà essere controllato da remoto.

Davvero pensavate che l'AI, il Machine Learning, i Big Data, il 5G, fossero tecnologie a favore dell'Uomo?

Fa tutto parte del piano diabolico.

Una volta smascherato il piano, si hanno tutti gli elementi per farlo fallire.

Integrale: https://www.youtube.com/watch?v=qyEw0NMyE0c

From: https://t.me/bguer

 

SCIOCCANTE: database dell’Organizzazione Mondiale della Sanità elenca 2.201.851 reazioni avverse al vaccino Covid-19, compresi problemi fetali.

https://www.eventiavversinews.it/scioccante-database-dellorganizzazione-mondiale-della-sanita-elenca-2-201-851-reazioni-avverse-al-vaccino-covid-19-compresi-problemi-fetali/

Il database – VigiAccess – elenca tutte le reazioni avverse segnalate per il vaccino Covid-19 Comirnaty e agli altri vaccini Covid ( i risultati sono complessivi di tutti i vaccini covid in uso indipendentemente dal nome commerciale inserito).

VigiAccess è gestito dal Centro di monitoraggio di Uppsala in Svezia ed è uno dei più grandi sistemi globali di segnalazione degli eventi avversi.

Avviando la ricerca, si presenta un elenco sezionato di reazioni che vanno dai disturbi cardiaci ai disturbi congeniti e genetici.

In totale, 2.201.851 reazioni avverse sono state segnalate al database.

Inoltre, il database afferma che ci sono stati 1191 disturbi congeniti (alla nascita) legati al Covid-19. Il maggior numero di segnalazioni rientra in una mutazione del fattore V di Leiden, una malattia genetica nota anche come Mutazione G1691A del Fattore V, è una condizione genetica che aumenta il rischio di sviluppare trombosi venosa (trombofilia). Se si sviluppa un coagulo, è probabile che si presenti sotto forma di trombosi venosa profonda o di embolia polmonare.

Questo suggerisce che il vaccino Covid-19 influisca effettivamente sulla fertilità e sullo sviluppo del feto nell’utero se la madre riceve un vaccino durante la gravidanza.

Ciò contraddice ciò che l’OMS e altre autorità sanitarie dichiarano, poiché stanno attivamente incoraggiando le donne incinte a vaccinarsi.

In Italia l’ISS , Istituto Superiore di Sanità, ha emanato un comunicato che incoraggia le donne in gravidanza a sottoporsi al vaccino Covid, affermando che i vaccini attualmente in uso sono “efficaci e hanno un buon profilo di sicurezza”.

Tuttavia, non è noto quali siano gli effetti delle proteine spike nel vaccino sulle donne in gravidanza e sul feto, considerando che questi vaccini non hanno affrontato test di sicurezza significativi.

Inoltre, nonostante le autorità sanitarie abbiano assicurato che i componenti del vaccino rimangano nel sito di iniezione una volta somministrato, uno studio giapponese di bio-distribuzione Pfizer ha rilevato alti livelli di nanoparticelle lipidiche dal vaccino accumulate in diverse parti del corpo, tra cui utero, ovaie e linfonodi.

ertanto, dobbiamo chiederci quali potrebbero essere le conseguenze a breve e lungo termine di questi ingredienti vaccinali che si accumulano negli organi di tutto il corpo.

Alcuni disturbi alla nascita riportati includono 64 casi di difetto del setto atriale (buco nel cuore) e 49 segnalazioni di cardiopatia congenita.

Il database offre una panoramica della posizione geografica delle segnalazioni, della distribuzione per fasce d’età e della distribuzione per sesso.

L’Europa è responsabile del 50% dei casi elencati nel database, mentre il 38% proviene dal continente americano. Il 6% delle segnalazioni proviene dall’Asia e il 3% proviene rispettivamente da Africa e Oceania.

embra che il vaccino Covid-19 non discrimini per età o sesso, in quanto ha riportato effetti su tutte le fasce d’età e su entrambi i sessi.

Il gruppo di età più colpito è quello di età compresa tra 18 e 44 anni, con il 39% di incidenza.

Il secondo gruppo più colpito è quello dai 45 ai 64 anni, con il 31% dei casi legati a questa coorte.

Sorprendentemente, ci sono stati 301 eventi avversi segnalati nei bambini di età compresa tra 0 e 27 giorni e ulteriori 1327 reazioni segnalate nei bambini di età compresa tra 28 giorni e 23 mesi.

Il 12% delle reazioni elencate in VigiAccess riguarda individui la cui età non è nota.

er quanto riguarda il genere, il vaccino Covid-19 sembra colpire le donne più degli uomini, con il 69% delle reazioni legate alle donne e il 30% agli uomini.

Tuttavia, l’1% (28440) rientra nei report in cui il genere è sconosciuto.

Study NCT04368728

Study NCT04368728
Submitted Date:  August 4, 2021 (v32)

---

Study Identification Unique Protocol ID: C4591001 Brief Title: Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals Official Title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS Secondary IDs: 2020-002641-42 [EudraCT Number]
Study Status Record Verification: August 2021 Overall Status: Recruiting Study Start: April 29, 2020 Primary Completion: May 2, 2023 [Anticipated] Study Completion: May 2, 2023 [Anticipated] First Submitted: April 27, 2020 First Submitted that Met QC Criteria: April 29, 2020 First Posted: April 30, 2020 [Actual] Last Update Submitted that Met QC Criteria: August 4, 2021 Last Update Posted: August 5, 2021 [Actual]
Sponsor/Collaborators Sponsor: BioNTech SE Responsible Party: Sponsor Collaborators: Pfizer
Oversight U.S. FDA-regulated Drug: Yes U.S. FDA-regulated Device: No Data Monitoring: Yes
Study Description Brief Summary: This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: As a 2-dose (separated by 21 days) schedule; At various different dose levels in Phase 1; As a booster; In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days. Detailed Description:
Conditions Conditions: SARS-CoV-2 Infection COVID-19 Keywords: COVID-19 Coronavirus Vaccine SARS-CoV-2 RNA Vaccine
Study Design Study Type: Interventional Primary Purpose: Prevention Study Phase: Phase 2/Phase 3 Interventional Study Model: Parallel Assignment Number of Arms: 20 Masking: Triple (Participant, Care Provider, Investigator) Allocation: Randomized Enrollment: 43998 [Anticipated]
Arms and Interventions Arms Assigned Interventions Experimental: 10 µg dose, 18-55 years of age (2 doses) Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection Experimental: 20 µg dose, 18-55 years of age (2 doses) Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection Experimental: 30 µg dose, 18-55 years of age (2 doses) Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection Experimental: 10 µg dose, 65-85 years of age (2 doses) Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection Experimental: 20 µg dose, 65-85 years of age (2 doses) Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection Experimental: 30 µg dose, 65-85 years of age (2 doses) Biological: BNT162b1 Intramuscular injection Biological: BNT162b2 Intramuscular injection Experimental: 30 µg dose, ≥12 years of age (2 doses) Biological: BNT162b2 Intramuscular injection Placebo Comparator: Placebo, 18-55 years of age Placebo Intramuscular injection Placebo Comparator: Placebo, 65-85 years of age Placebo Intramuscular injection Placebo Comparator: Placebo, ≥12 years of age Placebo Intramuscular injection Experimental: 100 µg dose, 18-55 years of age (2 doses) Biological: BNT162b1 Intramuscular injection Vaccination of Placebo recipients with BNT162b2 - Stage 1 Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study. Biological: BNT162b2 Intramuscular injection Vaccination of placebo recipients with BNT162b2 - Stage 2 Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. Biological: BNT162b2 Intramuscular injection Experimental: Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg Biological: BNT162b2 Intramuscular injection Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg Biological: BNT162b2 Intramuscular injection Experimental: Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg Biological: BNT162b2SA Intramuscular injection Experimental: Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg Biological: BNT162b2SA Intramuscular injection Experimental: Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg Biological: BNT162b2SA Intramuscular injection Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg Biological: BNT162b2 Intramuscular injection Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg Biological: BNT162b2 Intramuscular injection
Outcome Measures Primary Outcome Measures: 1. Percentage of participants in Phase 1 reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries. 2. Percentage of participants in Phase 1 reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. 3. Percentage of participants in Phase 1 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ] As elicited by investigational site staff 4. Percentage of participants in Phase 1 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ] As elicited by investigational site staff 5. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ] As measured at the central laboratory 6. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ] As measured at the central laboratory 7. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ] As measured at the central laboratory 8. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ] As measured at the central laboratory 9. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ] As measured at the central laboratory 10. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ] As measured at the central laboratory 11. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries. 12. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. 13. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ] As elicited by investigational site staff 14. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ] As elicited by investigational site staff 15. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries. 16. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. 17. Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ] As elicited by investigational site staff 18. Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ] As elicited by investigational site staff 19. Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 20. Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 21. Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ] As elicited by investigational site staff 22. Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 6 months after the last dose ] As elicited by investigational site staff 23. In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries. 24. In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. 25. In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ] As elicited by investigational site staff 26. In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 5 or 6 months after the last dose ] As elicited by investigational site staff 27. In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 (and dose 2) ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries. 28. In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 (and dose 2) ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. 29. In participants who receive a third dose of BNT162b2, percentage of participants reporting adverse events [ Time Frame: From the third dose through 1 month after the third dose ] As elicited by investigational site staff 30. In participants who receive a third dose of BNT162b2, percentage of participants reporting serious adverse events [ Time Frame: From the third dose through 6 months after the third dose ] As elicited by investigational site staff 31. In participants who receive a third dose of BNT162b2, percentage of participants reporting local reactions [ Time Frame: For 7 days after the third dose ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries. 32. In participants who receive a third dose of BNT162b2, percentage of participants reporting systemic events [ Time Frame: For 7 days after the third dose ] Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. 33. Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ] As measured at the central laboratory 34. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ] As measured at the central laboratory 35. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ] As measured at the central laboratory Secondary Outcome Measures: 1. In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 2 years after the final dose ] As measured at the central laboratory 2. In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ] As measured at the central laboratory 3. Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels [ Time Frame: Through 2 years after the final dose ] As measured at the central laboratory 4. In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs [ Time Frame: Through 2 years after the final dose ] As measured at the central laboratory 5. Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels [ Time Frame: Through 2 years after the final dose ] As measured at the central laboratory 6. In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ] As measured at the central laboratory 7. In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels [ Time Frame: Through 2 years after the final dose ] As measured at the central laboratory 8. Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 9. Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 10. Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 11. Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 12. Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 13. Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 14. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 15. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 16. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 17. Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ] Per 1000 person-years of follow-up 18. GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) [ Time Frame: 1 month after the second dose ] As measured at the central laboratory 19. Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose [ Time Frame: Through 1 month after the second dose ] Per 1000 person-years of follow-up 20. Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection [ Time Frame: Through 6 months after the second dose ] Per 1000 person-years of follow-up 21. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ] As measured at the central laboratory 22. Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the first dose of BNT162b2SA ] As measured at the central laboratory 23. Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg [ Time Frame: 1 month after the first dose of BNT162b2SA/third dose of BNT162b2 ] As measured at the central laboratory 24. Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the second dose of BNT162b2SA ] As measured at the central laboratory 25. Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ] As measured at the central laboratory 26. Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ] As measured at the central laboratory
Eligibility Minimum Age: 12 Years Maximum Age: Sex: All Gender Based: Accepts Healthy Volunteers: Yes Criteria: Inclusion Criteria: • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization. Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment. Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization. Note that participants <18 years of age cannot be enrolled in the EU. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. Boostability and protection-against-VOCs existing participant subset only: Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window. Capable of giving personal signed informed consent Exclusion Criteria: Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). Receipt of medications intended to prevent COVID 19. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19 Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors: Hypertension Diabetes mellitus Chronic pulmonary disease Asthma Current vaping or smoking History of chronic smoking within the prior year BMI >30 kg/m2 Anticipating the need for immunosuppressive treatment within the next 6 months Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Women who are pregnant or breastfeeding. Previous vaccination with any coronavirus vaccine. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation. Previous participation in other studies involving study intervention containing lipid nanoparticles. Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit. Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Contacts/Locations Central Contact Person: Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Email: ClinicalTrials.gov_Inquiries@pfizer.com Study Officials: Pfizer CT.gov Call Center Study Director Pfizer Locations: United States, Alabama North Alabama Research Center, LLC [Active, not recruiting] Athens, Alabama, United States, 35611 Birmingham Clinical Research Unit [Active, not recruiting] Birmingham, Alabama, United States, 35216 Medical Affiliated Research Center [Active, not recruiting] Huntsville, Alabama, United States, 35801 Optimal Research, LLC [Active, not recruiting] Huntsville, Alabama, United States, 35802 Alliance for Multispecialty Research, LLC [Active, not recruiting] Mobile, Alabama, United States, 36608 United States, Arizona Chinle Comprehensive Health Care Facility [Active, not recruiting] Chinle, Arizona, United States, 86503 Johns Hopkins Center for American Indian Health [Active, not recruiting] Chinle, Arizona, United States, 86503 The Pain Center of Arizona [Active, not recruiting] Phoenix, Arizona, United States, 85018 HOPE Research Institute [Active, not recruiting] Phoenix, Arizona, United States, 85023 Alliance for Multispecialty Research, LLC [Active, not recruiting] Tempe, Arizona, United States, 85281 Whiteriver Indian Hospital [Active, not recruiting] Whiteriver, Arizona, United States, 85941 United States, California Anaheim Clinical Trials, LLC [Active, not recruiting] Anaheim, California, United States, 92801 Collaborative Neuroscience Research, LLC [Active, not recruiting] Long Beach, California, United States, 90806 Long Beach Clinical Trials Services Inc. [Active, not recruiting] Long Beach, California, United States, 90806 Kaiser Permanente Los Angeles Medical Center [Active, not recruiting] Los Angeles, California, United States, 90027 National Research Institute [Active, not recruiting] Los Angeles, California, United States, 90057 Providence Clinical Research [Active, not recruiting] North Hollywood, California, United States, 91606 Paradigm Clinical Research Center [Active, not recruiting] Redding, California, United States, 96001 Kaiser Permanente Sacramento [Active, not recruiting] Sacramento, California, United States, 95815 UC Davis Medical Center [Active, not recruiting] Sacramento, California, United States, 95817 California Research Foundation [Active, not recruiting] San Diego, California, United States, 92123-1881 Kaiser Permanente Santa Clara [Active, not recruiting] Santa Clara, California, United States, 95051 Bayview Research Group [Active, not recruiting] Valley Village, California, United States, 91607 Diablo Clinical Research, Inc. [Active, not recruiting] Walnut Creek, California, United States, 94598 United States, Colorado Lynn Institute of Denver [Active, not recruiting] Aurora, Colorado, United States, 80012 United States, Connecticut Clinical Research Consulting, LLC [Active, not recruiting] Milford, Connecticut, United States, 06460 Yale Center for Clinical Investigations (CSRU) [Active, not recruiting] New Haven, Connecticut, United States, 06519 United States, Florida Alliance for Multispecialty Research, LLC-Miami [Active, not recruiting] Coral Gables, Florida, United States, 33134 Clinical Research of South Florida [Active, not recruiting] Coral Gables, Florida, United States, 33134 DeLand Clinical Research Unit [Active, not recruiting] DeLand, Florida, United States, 32720 Fleming Island Center for Clinical Research [Active, not recruiting] Fleming Island, Florida, United States, 32003 Indago Research & Health Center, Inc [Active, not recruiting] Hialeah, Florida, United States, 33012 Research Centers of America [Active, not recruiting] Hollywood, Florida, United States, 33024 Jacksonville Center for Clinical Research [Active, not recruiting] Jacksonville, Florida, United States, 32216 Clinical Neuroscience Solutions, Inc. [Active, not recruiting] Jacksonville, Florida, United States, 32256 Acevedo Clinical Research Associates [Active, not recruiting] Miami, Florida, United States, 33142 Clinical Neuroscience Solutions, Inc. dba CNS Healthcare [Active, not recruiting] Orlando, Florida, United States, 32801 United States, Georgia Atlanta Center for Medical Research [Active, not recruiting] Atlanta, Georgia, United States, 30331 IACT Health [Active, not recruiting] Columbus, Georgia, United States, 31904 Meridian Clinical Research, LLC [Active, not recruiting] Savannah, Georgia, United States, 31406 Clinical Research Atlanta [Active, not recruiting] Stockbridge, Georgia, United States, 30281 United States, Hawaii East-West Medical Research Institute [Active, not recruiting] Honolulu, Hawaii, United States, 96814 United States, Idaho Solaris Clinical Research [Active, not recruiting] Meridian, Idaho, United States, 83646 United States, Illinois Optimal Research, LLC [Active, not recruiting] Peoria, Illinois, United States, 61614 United States, Iowa University of Iowa Hospitals & Clinics Investigational Drug Servces [Active, not recruiting] Iowa City, Iowa, United States, 42242 University of Iowa Hospitals & Clinics [Active, not recruiting] Iowa City, Iowa, United States, 52242 Meridian Clinical Research, LLC [Active, not recruiting] Sioux City, Iowa, United States, 51106 United States, Kansas Alliance for Multispecialty Research, LLC [Active, not recruiting] Newton, Kansas, United States, 67114 Alliance for Multispecialty Research, LLC [Active, not recruiting] Wichita, Kansas, United States, 67207 United States, Kentucky Kentucky Pediatric/ Adult Research [Active, not recruiting] Bardstown, Kentucky, United States, 40004 United States, Louisiana Benchmark Research [Active, not recruiting] Metairie, Louisiana, United States, 70006 Ochsner Clinic Foundation [Active, not recruiting] New Orleans, Louisiana, United States, 70121 LSUHSC-Shreveport Clinical Trials Office [Active, not recruiting] Shreveport, Louisiana, United States, 71101 LSUHSC-Shreveport [Active, not recruiting] Shreveport, Louisiana, United States, 71103 United States, Maryland Pharmaron CPC, Inc. [Active, not recruiting] Baltimore, Maryland, United States, 21201 University of Maryland Medical Center Investigational Drug Service Pharmacy [Active, not recruiting] Baltimore, Maryland, United States, 21201 University of Maryland, Baltimore, Health Sciences Research Facility III [Active, not recruiting] Baltimore, Maryland, United States, 21201 University of Maryland, Center for Vaccine Development and Global Health [Active, not recruiting] Baltimore, Maryland, United States, 21201 Center for Immunization Research Inpatient Unit [Active, not recruiting] Baltimore, Maryland, United States, 21224 United States, Massachusetts Boston Medical Center [Active, not recruiting] Boston, Massachusetts, United States, 02118 UMass Memorial Medical Center - University Campus [Active, not recruiting] Worcester, Massachusetts, United States, 01655 United States, Michigan Michigan Center for Medical Research [Active, not recruiting] Farmington Hills, Michigan, United States, 48334 United States, Mississippi MedPharmics, Limited Liability Company [Active, not recruiting] Gulfport, Mississippi, United States, 39503 MedPharmics, LLC [Active, not recruiting] Gulfport, Mississippi, United States, 39503 United States, Missouri Clinical Research Professionals [Active, not recruiting] Chesterfield, Missouri, United States, 63005 Sundance Clinical Research, LLC [Active, not recruiting] Saint Louis, Missouri, United States, 63141 United States, Nebraska Methodist Physicians Clinic / CCT Research [Active, not recruiting] Fremont, Nebraska, United States, 68025 Meridian Clinical Research, LLC [Active, not recruiting] Norfolk, Nebraska, United States, 68701 Quality Clinical Research, Inc. [Active, not recruiting] Omaha, Nebraska, United States, 68114 Meridian Clinical Research, LLC [Active, not recruiting] Omaha, Nebraska, United States, 68134 United States, Nevada Wake Research-Clinical Research Center of Nevada, LLC [Active, not recruiting] Las Vegas, Nevada, United States, 89104 United States, New Jersey Amici Clinical Research [Active, not recruiting] Raritan, New Jersey, United States, 08869 South Jersey Infectious Disease [Active, not recruiting] Somers Point, New Jersey, United States, 08244 United States, New Mexico Johns Hopkins Center for American Indian Health [Active, not recruiting] Gallup, New Mexico, United States, 87301 Johns Hopkins Center for American Indian Health [Active, not recruiting] Shiprock, New Mexico, United States, 87420 United States, New York Meridian Clinical Research, LLC [Active, not recruiting] Binghamton, New York, United States, 13901 Meridian Clinical Research LLC [Active, not recruiting] Endwell, New York, United States, 13760 NYU Langone Health [Active, not recruiting] New York, New York, United States, 10016 Icahn School of Medicine at Mount Sinai [Active, not recruiting] New York, New York, United States, 10029 Rochester Clinical Research, Inc. [Active, not recruiting] Rochester, New York, United States, 14609 Rochester Regional Health/Rochester General Hospital [Active, not recruiting] Rochester, New York, United States, 14621 SUNY Upstate Medical University [Active, not recruiting] Syracuse, New York, United States, 13210 SUNY Upstate Medical University [Active, not recruiting] Syracuse, New York, United States, 13215 United States, North Carolina PMG Research of Raleigh, LLC d/b/a PMG Research of Cary [Active, not recruiting] Cary, North Carolina, United States, 27518 PMG Research of Charlotte LLC [Active, not recruiting] Charlotte, North Carolina, United States, 28209 Clinical Research Pickett Road [Active, not recruiting] Durham, North Carolina, United States, 27705 Accessioning Unit and Repository [Active, not recruiting] Durham, North Carolina, United States, 27710 Duke University Medicine Circle- Duke Early Phase Clinical Research Unit [Active, not recruiting] Durham, North Carolina, United States, 27710 PharmQuest [Active, not recruiting] Greensboro, North Carolina, United States, 27408 PMG Research of Hickory, LLC [Active, not recruiting] Hickory, North Carolina, United States, 28601 PMG Research of Raleigh, LLC [Active, not recruiting] Raleigh, North Carolina, United States, 27609 M3 Wake Research, Inc. [Active, not recruiting] Raleigh, North Carolina, United States, 27612 PMG Research of Salisbury, LLC [Active, not recruiting] Salisbury, North Carolina, United States, 28144 PMG Research of Wilmington, LLC [Active, not recruiting] Wilmington, North Carolina, United States, 28401 PMG Research of Winston-Salem, LLC [Active, not recruiting] Winston-Salem, North Carolina, United States, 27103 United States, North Dakota Lillestol Research Llc [Active, not recruiting] Fargo, North Dakota, United States, 58104 United States, Ohio Sterling Research Group, Ltd. [Active, not recruiting] Cincinnati, Ohio, United States, 45219 Cincinnati Children's Hospital Medical Center [Active, not recruiting] Cincinnati, Ohio, United States, 45229-3039 Sterling Research Group, Ltd. [Active, not recruiting] Cincinnati, Ohio, United States, 45246 University Hospitals Cleveland Medical Center [Active, not recruiting] Cleveland, Ohio, United States, 44106 VA Northeast Ohio Healthcare System [Active, not recruiting] Cleveland, Ohio, United States, 44106 Velocity Clinical Research, Inc. [Active, not recruiting] Cleveland, Ohio, United States, 44122 Aventiv Research Inc. [Active, not recruiting] Columbus, Ohio, United States, 43213 Dayton Clinical Research [Active, not recruiting] Dayton, Ohio, United States, 45406 PriMED Clinical Research [Active, not recruiting] Dayton, Ohio, United States, 45419 Senders Pediatrics [Active, not recruiting] South Euclid, Ohio, United States, 44121 United States, Oklahoma Lynn Institute of Norman [Active, not recruiting] Norman, Oklahoma, United States, 73072 United States, Oregon Kaiser Permanente Northwest-Center for Health Research [Active, not recruiting] Portland, Oregon, United States, 97227 United States, Pennsylvania Lehigh Valley Health Network/Network Office of Research and Innovation [Active, not recruiting] Allentown, Pennsylvania, United States, 18102 United States, Rhode Island Velocity Clinical Research, Providence [Active, not recruiting] Warwick, Rhode Island, United States, 02886 United States, South Carolina Main Street Physician's Care [Active, not recruiting] Little River, South Carolina, United States, 29566 Main Street Physician's Care [Active, not recruiting] Loris, South Carolina, United States, 29569 United States, Tennessee Holston Medical Group [Active, not recruiting] Bristol, Tennessee, United States, 37620 Holston Medical Group [Active, not recruiting] Kingsport, Tennessee, United States, 37660 Alliance for Multispecialty Research, LLC [Active, not recruiting] Knoxville, Tennessee, United States, 37909 Alliance for Multispecialty Research, LLC [Active, not recruiting] Knoxville, Tennessee, United States, 37920 Clinical Neuroscience Solutions, Inc. [Active, not recruiting] Memphis, Tennessee, United States, 38119 Clinical Research Associates, Inc. [Active, not recruiting] Nashville, Tennessee, United States, 37203 Trinity Clinical Research [Active, not recruiting] Tullahoma, Tennessee, United States, 37388 United States, Texas Benchmark Research [Active, not recruiting] Austin, Texas, United States, 78705 ARC Clinical Research at Wilson Parke [Active, not recruiting] Austin, Texas, United States, 78726 Tekton Research, Inc. [Active, not recruiting] Austin, Texas, United States, 78745 North Texas Infectious Diseases Consultants, P.A. [Active, not recruiting] Dallas, Texas, United States, 75246 Ventavia Research Group, LLC [Active, not recruiting] Fort Worth, Texas, United States, 76104 Benchmark Research [Active, not recruiting] Fort Worth, Texas, United States, 76135 Texas Health Resources [Active, not recruiting] Fort Worth, Texas, United States, 76135 University of Texas Medical Branch [Active, not recruiting] Galveston, Texas, United States, 77555 Ventavia Research Group, LLC [Active, not recruiting] Houston, Texas, United States, 77008 Texas Center for Drug Development, Inc. [Active, not recruiting] Houston, Texas, United States, 77081 Ventavia Research Group, LLC [Active, not recruiting] Keller, Texas, United States, 76248 SMS Clinical Research, LLC [Active, not recruiting] Mesquite, Texas, United States, 75149 LinQ Research, LLC [Active, not recruiting] Pearland, Texas, United States, 77584 Benchmark Research. [Active, not recruiting] San Angelo, Texas, United States, 76904 Clinical Trials of Texas, Inc. [Active, not recruiting] San Antonio, Texas, United States, 78229 Diagnostics Research Group [Active, not recruiting] San Antonio, Texas, United States, 78229 Martin Diagnostic Clinic [Active, not recruiting] Tomball, Texas, United States, 77375 United States, Utah J. Lewis Research, Inc. / Foothill Family Clinic [Active, not recruiting] Salt Lake City, Utah, United States, 84109 J. Lewis Research, Inc. / Foothill Family Clinic South [Active, not recruiting] Salt Lake City, Utah, United States, 84121 United States, Virginia Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) [Active, not recruiting] Annandale, Virginia, United States, 22003 Virginia Research Center LLC [Active, not recruiting] Midlothian, Virginia, United States, 23114 United States, Washington Benaroya Research Institute at Virginia Mason [Active, not recruiting] Seattle, Washington, United States, 98101 Wenatchee Valley Hospital [Active, not recruiting] Wenatchee, Washington, United States, 98801 Argentina Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich [Active, not recruiting] Caba, Argentina, 1426 Brazil CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda (Casa Branca) [Recruiting] Sao Paulo, Brazil, 04266-010 Brazil, Bahia Hospital Santo Antonio/ Associacao Obras Sociais Irma Dulce [Active, not recruiting] Salvador, Bahia, Brazil, CEP: 40415-006 Germany CRS Clinical Research Services Berlin GmbH [Active, not recruiting] Berlin, Germany, 13353 Medizentrum Essen Borbeck [Active, not recruiting] Essen, Germany, 45355 IKF Pneumologie GmbH & Co KG [Active, not recruiting] Frankfurt am Main, Germany, 60596 Universitätsklinikum Hamburg-Eppendorf [Active, not recruiting] Hamburg, Germany, 20359 CRS Clinical Research Services Mannheim GmbH [Active, not recruiting] Mannheim, Germany, 68167 Studienzentrum Brinkum Dr. Lars Pohlmeier und Torsten Drescher [Active, not recruiting] Stuhr, Germany, 28816 South Africa, Gauteng Newtown Clinical Research Centre [Active, not recruiting] Johannesburg, Gauteng, South Africa, 2113 Jongaie Research [Active, not recruiting] Pretoria, Gauteng, South Africa, 0183 South Africa, Limpopo Limpopo Clinical Research Initiative [Active, not recruiting] Thabazimbi, Limpopo, South Africa, 0380 South Africa, Western CAPE Tiervlei Trial Centre, Basement Level, Karl Bremer Hospital [Active, not recruiting] Cape Town, Western CAPE, South Africa, 7530 Turkey Ankara Universitesi Tip Fakultesi, Ibni Sina Hastanesi [Active, not recruiting] Ankara, Turkey, 06230 Hacettepe Universitesi Tip Fakultesi [Active, not recruiting] Ankara, Turkey, 06230 Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi [Active, not recruiting] Istanbul, Turkey, 34020 Istanbul Universitesi Istanbul Tip Fakultesi [Active, not recruiting] Istanbul, Turkey, 34093 Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi [Active, not recruiting] Istanbul, Turkey, 34098 Medipol Mega Universite Hastanesi [Active, not recruiting] Istanbul, Turkey, 34214 Acibadem Atakent Hastanesi [Active, not recruiting] Istanbul, Turkey, 34303 Kocaeli Universitesi Tip Fakultesi [Active, not recruiting] Kocaeli, Turkey, 41380 Sakarya Universitesi Egitim ve Arastirma Hastanesi [Active, not recruiting] Sakarya, Turkey, 54100
IPDSharing Plan to Share IPD: Yes Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. Supporting Information: Time Frame: Access Criteria: URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
References Links: URL: https://pmiform.com/clinical-trial-info-request?StudyID=C4591001  Description: To obtain contact information for a study center near you, click here. Available IPD/Information: