Mario Freedom's Space: 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]

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:

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

Mario Freedom's Space

Monday, 25 October 2021

Study NCT04368728

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