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History of Changes for Study: NCT04368728
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Latest version (submitted August 25, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 29, 2020 None (earliest Version on record)
2 May 4, 2020 Recruitment Status, Study Status, Study Design, References, Contacts/Locations and Oversight
3 May 5, 2020 Study Design and Study Status
4 May 13, 2020 Study Status and Contacts/Locations
5 June 4, 2020 Study Status, Contacts/Locations, Study Design and Study Identification
6 June 26, 2020 Contacts/Locations, Study Design and Study Status
7 July 15, 2020 Recruitment Status, Arms and Interventions, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Design, Study Description and Study Identification
8 July 21, 2020 Contacts/Locations, Study Design, Study Status and Study Identification
9 July 27, 2020 IPDSharing, References, Contacts/Locations, Study Design, Study Status and Study Identification
10 July 30, 2020 Recruitment Status, Study Status and Contacts/Locations
11 July 31, 2020 Arms and Interventions, Outcome Measures, Study Status, References, Contacts/Locations, Eligibility, Study Design and Study Description
12 August 6, 2020 Contacts/Locations and Study Status
13 August 17, 2020 Contacts/Locations and Study Status
14 September 3, 2020 Contacts/Locations and Study Status
15 September 25, 2020 Contacts/Locations, Eligibility, Study Status, Arms and Interventions, Study Identification, Study Design and Study Description
16 October 14, 2020 Contacts/Locations, Study Status and Eligibility
17 October 23, 2020 Outcome Measures, Contacts/Locations, Arms and Interventions, Eligibility, Study Description and Study Status
18 October 30, 2020 Contacts/Locations and Study Status
19 November 11, 2020 Study Status, Contacts/Locations and Outcome Measures
20 November 20, 2020 Study Status and Contacts/Locations
21 December 15, 2020 Study Status and Contacts/Locations
22 December 22, 2020 Arms and Interventions, Study Description and Study Status
23 January 8, 2021 Study Status, Contacts/Locations and Study Design
24 January 20, 2021 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Study Design
25 February 9, 2021 Study Status
26 March 17, 2021 Contacts/Locations, Arms and Interventions, Study Status and Study Description
27 March 30, 2021 Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Eligibility and Study Description
28 April 9, 2021 Recruitment Status, Study Status and Contacts/Locations
29 April 29, 2021 Arms and Interventions, Outcome Measures, Contacts/Locations, Eligibility, Study Design, Study Description and Study Status
30 May 28, 2021 Study Status, Contacts/Locations and Study Design
31 July 21, 2021 Study Status, Contacts/Locations and Eligibility
32 August 4, 2021 Study Status and Contacts/Locations
33 August 25, 2021 Contacts/Locations and Study Status
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Study NCT04368728
Submitted Date:  April 29, 2021 (v29)

Open or close this module 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]
Open or close this module Study Status
Record Verification: April 2021
Overall Status: Recruiting
Study Start: April 29, 2020
Primary Completion: October 29, 2021 [Anticipated]
Study Completion: April 6, 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:
April 29, 2021
Last Update Posted: May 4, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BioNTech SE
Responsible Party: Sponsor
Collaborators: Pfizer
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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:
Open or close this module Conditions
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Open or close this module 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: 46663 [Anticipated]
Open or close this module 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
Open or close this module 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
Open or close this module 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 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.
Open or close this module 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
[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, 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
[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
Rapid Medical 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, 73069
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
Omega Medical Research
[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
Open or close this module 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
Open or close this module References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:

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