To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

Sponsor
BioNTech SE (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04955626
Collaborator
Pfizer (Industry)
10,000
Enrollment
153
Locations
4
Arms
24.4
Anticipated Duration (Months)
65.4
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization.

The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19

  • At a dose of 30µg (as studied in the Phase 2/3 study C4591001)

  • In healthy adults 16 years of age and older

  • The duration of the study for each participant will be up to approximately 12 months.

  • The study will be conducted in the United States, Brazil and South Africa

Substudy B: The study will assess the safety and tolerability of a single dose of BNT162b2 as compared to placebo control, through the potential analysis of serum troponin levels, in participants ≥12 and ≤30 years of age who have completed a 2-dose primary series of BNT162b2 (30-µg doses) at least 5 months prior to randomization.

  • Blood samples will be collected for troponin testing

  • The duration of the study for each participant will be up to approximately 2 months.

  • The study will be conducted in the United States, Germany, Poland and South Africa

Substudy C: The study will assess the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at doses of 10 µg or 30 µg in participants who have completed a 2-dose primary series of BNT162b2 (30 µg doses) at least 5 months prior to randomization.

  • In healthy adults 12 years of age and older

  • The duration of the study for each participant will be up to approximately 12 months.

  • The study will be conducted in the United States, Germany and South Africa

Substudy D: The study will assess the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third or fourth) dose

  • Participants in Cohort 1 will have completed a 2-dose primary series of BNT162b2 (30-µg doses), with their last dose 90 to 240 days prior to enrollment

  • Participants in Cohort 2 will be enrolled from Study C4591001 and C4591031 Substudy A and will have completed a 2-dose primary series and received a single booster (third) dose of BNT162b2, with their last dose 90 to 180 days prior to randomization

  • Participants in Cohort 3 who are COVID-19 vaccine-naïve and have not experienced COVID-19 will be enrolled to receive 2 doses (primary series) of BNT162b2 OMI, 3 weeks apart, with a third dose approximately 5 months later.

  • In healthy adults 18 to 55 years of age

  • The duration of the study for each participant will be up to approximately 12 months.

  • The study will be conducted in the United States and South Africa

Substudy E: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose

  • In healthy adults > 55 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being 5 to 12 months prior to randomization

  • The duration of the study for each participant will be approximately 6 months.

  • The study will be conducted in the United States

Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose.

  • In healthy adults 60 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being ≥4 months prior to randomization

  • The duration of the study for each participant will be approximately 6 months.

  • The study will be conducted in Israel

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: BNT162b2
  • Other: Placebo
  • Biological: BNT162b2 OMI
  • Biological: Combination BNT162b2 and BNT162b2 OMI
  • Biological: Combination (Bivalent) BNT162b2 and BNT162b2 OMI
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162B2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162B2
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 13, 2023
Anticipated Study Completion Date :
Jul 13, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: 10 µg dose

1 dose

Biological: BNT162b2
Intramuscular Injection

Placebo Comparator: Placebo

1 dose

Other: Placebo
Intramuscular Injection

Experimental: 30 µg dose

1 dose

Biological: BNT162b2
Intramuscular Injection

Biological: BNT162b2 OMI
Intramuscular Injection

Biological: Combination BNT162b2 and BNT162b2 OMI
30-µg (15-µg each) or 60-µg (30-µg each) Intramuscular Injection

Biological: Combination (Bivalent) BNT162b2 and BNT162b2 OMI
30-µg (15-µg each) or 60-µg (30-µg each) Intramuscular Injection

Experimental: 60 µg dose

1 dose

Biological: BNT162b2
Intramuscular Injection

Biological: BNT162b2 OMI
Intramuscular Injection

Biological: Combination BNT162b2 and BNT162b2 OMI
30-µg (15-µg each) or 60-µg (30-µg each) Intramuscular Injection

Biological: Combination (Bivalent) BNT162b2 and BNT162b2 OMI
30-µg (15-µg each) or 60-µg (30-µg each) Intramuscular Injection

Outcome Measures

Primary Outcome Measures

  1. SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection [from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months]

    per 1000 person-years of blinded follow-up

  2. SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection [from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months]

    per 1000 person-years of blinded follow-up

  3. SSA - Percentage of participants reporting adverse events [from the booster dose to 1 month after the booster dose]

    As elicited by investigational site staff

  4. SSA - Percentage of participants reporting serious adverse events [from the booster dose to 6 months after the booster dose]

    As elicited by investigational site staff

  5. SSB - Percentage of participants with elevated troponin I levels [through 1 month after the second vaccination]

    Troponin I level

  6. SSB - Percentage of participants reporting local reactions [For 7 days following each vaccination]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  7. SSB - Percentage of participants reporting systemic events [For 7 days following each vaccination]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  8. SSB - Percentage of participants reporting adverse events [within 1 month after each vaccination]

    As elicited by investigational site staff

  9. SSB - Percentage of participants reporting serious adverse events [within 1 month after each vaccination]

    As elicited by investigational site staff

  10. SSC - Percentage of participants reporting local reactions [For 7 days following the booster dose]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  11. SSC - Percentage of participants reporting systemic events [For 7 days following the booster dose]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  12. SSC - Percentage of participants reporting adverse events [from the booster dose to 1 month after the booster dose]

    As elicited by investigational site staff

  13. SSC - Percentage of participants reporting serious adverse events [from the booster dose to 6 months after the booster dose]

    As elicited by investigational site staff

  14. SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study [1 month after the booster (third) dose, and 1 month after the second dose for participants in the control group]

    GMR, estimated by the ratio of the GMTs of SARS-CoV-2 neutralizing titers at 1 month after the third dose in participants who received a booster (third) dose of BNT162b2 at 30 µg to those at 1 month after the second dose in age-matched participants randomly selected from the C4591001 study. The difference in the percentage of participants with seroresponse at 1 month after the third dose in participants who received a booster (third) dose of BNT162b2 at 30 µg and at 1 month after the second dose in age-matched participants randomly selected from the C4591001 study

  15. SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study [1 month after the booster (third) dose, and 1 month after the second dose for participants in the control group]

    GMR, estimated by the ratio of the GMTs of SARS-CoV-2 neutralizing titers at 1 month after the third dose in participants who received a booster (third) dose of BNT162b2 at 10 µg to those at 1 month after the second dose in age-matched participants randomly selected from the C4591001 study. The difference in percentage of participants with seroresponse at 1 month after the third dose in participants who received a booster (third) dose of BNT162b2 at 10 µg and at 1 month after the second dose in age-matched participants randomly selected from the C4591001 study

  16. SSD - Percentage of participants reporting local reactions [For 7 days following each vaccination]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  17. SSD - Percentage of participants reporting systemic events [For 7 days following each vaccination]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  18. SSD - Percentage of participants reporting adverse events [from the first study vaccination (received in this study) through 1 month after the last study vaccination]

    As elicited by investigational site staff

  19. SSD - Percentage of participants reporting serious adverse events [from the first study vaccination (received in this study) through 6 months after the last study vaccination]

    As elicited by investigational site staff

  20. SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention]

    GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants

  21. SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants [1 month after receipt of 1 or 2 doses of intervention as appropriate]

    GMR of the Omicron-neutralizing titers at 1 month after 2 doses of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 2 doses of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants

  22. SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention]

    GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants

  23. SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study [1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate]

    GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to 1 month after the second dose of BNT162b2 in age-matched participants randomly selected from the C4591001 study The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after the second dose of BNT162b2 OMI and at 1 month after the second dose of BNT162b2 in age-matched participants randomly selected from the C4591001 study

  24. SSE - Percentage of participants reporting local reactions [For 7 days following the study vaccination]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  25. SSE - Percentage of participants reporting systemic events [For 7 days following the study vaccination]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  26. SSE - Percentage of participants reporting adverse events [from the study vaccination through 1 month after the study vaccination]

    As elicited by investigational site staff

  27. SSE - Percentage of participants reporting serious adverse events [from the study vaccination through 6 months after the study vaccination]

    As elicited by investigational site staff

  28. SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the reference-strain neutralizing titers at 1 month after 1 dose of BNT162b2 at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants

  29. SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the Omicron neutralizing titers at 1 month after 1 dose of BNT162b2 at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 at 60 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants

  30. SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the Omicron neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants

  31. SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the reference-strain neutralizing titers at 1 month after 1 dose of BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the reference strain at 1 month after 1 dose of BNT162b2 OMI at 60 µg and at 1 month after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants

  32. SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the Omicron neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants

  33. SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the reference-strain neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the reference strain at 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants

  34. SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the reference-strain neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the reference strain at 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg and at 1 month after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants

  35. SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the reference-strain neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants

  36. SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the Omicron neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants

  37. SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the Omicron neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg to those at 1 month after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg and at 1 month after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants

  38. SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the Omicron neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants

  39. SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the reference-strain neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the reference strain at 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg and at 1 month after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants

  40. SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the reference-strain neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants

  41. SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention given as a fourth dose]

    GMR of the Omicron neutralizing titers 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg to those at 1 month after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg and at 1 month after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants

  42. SSF - Percentage of participants reporting local reactions [For 7 days following the study vaccination]

    Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

  43. SSF - Percentage of participants reporting systemic events [For 7 days following the study vaccination]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

  44. SSF - Percentage of participants reporting adverse events [from the study vaccination through 1 month after the study vaccination]

    As elicited by investigational site staff

  45. SSF - Percentage of participants reporting serious adverse events [from the study vaccination through 6 months after the study vaccination]

    As elicited by investigational site staff

  46. SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants [At each time point]

    GMT of Omicron and reference-strain neutralizing titers GMFRs of Omicron and reference-strain neutralizing titers from before the study vaccination to subsequent time points Percentages of participants with seroresponse for Omicron and reference-strain neutralizing titers at each time point

Secondary Outcome Measures

  1. SSA - Confirmed severe COVID-19 (based on FDA definition) period in participants without evidence of past SARS-CoV-2 infection [from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months]

    per 1000 person-years of blinded follow-up

  2. SSA - Confirmed severe COVID-19 (based on FDA definition) in participants with and without evidence of past SARS-CoV-2 infection [from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months]

    per 1000 person-years of blinded follow-up

  3. SSA - Confirmed severe COVID-19 (based on CDC definition) in participants without evidence of past SARS-CoV-2 infection [from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months]

    per 1000 person-years of blinded follow-up

  4. SSA - Confirmed severe COVID-19 (based on CDC definition) in participants with and without evidence of past SARS-CoV-2 infection [from 7 days after the booster dose through the blinded follow-up period, which may be from 2 to 12 months]

    per 1000 person-years of blinded follow-up

  5. SSA - Incidence of asymptomatic SARS-CoV-2 infection based on N-binding antibody in participants without evidence of past SARS-CoV-2 infection [From the booster dose through the blinded follow-up period, which may be from 2 to 12 months]

    per 1000 person-years of follow-up

  6. SSC - Immune responses induced by a booster (third) dose of BNT162b2 at 10 µg and 30 µg [Through 1 year after the booster (third) dose]

    GMTs of SARS-CoV-2 neutralizing titers GMFRs of SARS-CoV-2 neutralizing titers

  7. SSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention]

    GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants

  8. SSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants [1 month after receipt of 1 or 2 doses of intervention as appropriate]

    GMR of the Omicron-neutralizing titers at 1 month after 2 doses of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 2 doses of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the third (and fourth) dose in BNT162b2-experienced participants

  9. SSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants [1 month after receipt of 1 dose of study intervention]

    GMR of the Omicron-neutralizing titers at 1 month after 1 dose of BNT162b2 OMI to those at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after 1 dose of BNT162b2 OMI and at 1 month after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants

  10. SSD - The noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study [1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate]

    GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to the reference-strain-neutralizing titers 1 month after the second dose of BNT162b2 in age-matched participants randomly selected from the C4591001 study The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after the second dose of BNT162b2 OMI and seroresponsea to the reference strain at 1 month after the second dose of BNT162b2 in age-matched participants randomly selected from the C4591001 study

  11. SSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study [1 month after receipt of the second dose of BNT162b2 OMI or BNT162b2 as appropriate]

    GMR of the Omicron-neutralizing titers 1 month after the second dose of BNT162b2 OMI to 1 month after the second dose of BNT162b2 in age-matched participants randomly selected from the C4591001 study The difference in percentages of participants with seroresponse to the Omicron strain at 1 month after the second dose of BNT162b2 OMI and at 1 month after the second dose of BNT162b2 in age-matched participants randomly selected from the C4591001 study

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Substudy A

Inclusion Criteria:
  • Male or female participants ≥16 years of age at Visit 1 (Day 1) who participated in C4591001.

  • 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Capable of giving signed informed consent.

  • Participants who have received 2 prior doses of 30 µg BNT162b2 19-42 days apart, with the second dose being at least 175 days before Visit 1 (Day 1).

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.

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

  • 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.

  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • 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.

  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

  • Prior receipt of any COVID-19 vaccine other than BNT162b2.

  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

  • Receipt of medications intended to prevent COVID-19.

  • Prior receipt of more than 2 doses of BNT162b2 30 µg.

  • Participation in other studies involving study intervention within 28 days prior to study entry, other than C4591001, and/or within 28 days of confirmed receipt of BNT162b2 within the study.

Substudy B

Inclusion Criteria:
  • Male or female participants12 to 30 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least 150 days before Visit 1 (Day 1)

  • 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Capable of giving 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.

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

  • 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.

  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • 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.

  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

  • Prior receipt of any COVID-19 vaccine other than BNT162b2.

  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

  • Receipt of medications intended to prevent COVID-19.

  • Prior receipt of more than 2 doses of BNT162b2 30 µg.

  • Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days 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.

Substudy C

Inclusion Criteria:
  • Male or female participants ≥12 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least 150 days before Visit 301 (Day 1)

  • 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Capable of giving 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.

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

  • 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.

  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • 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.

  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

  • Prior receipt of any COVID-19 vaccine other than BNT162b2.

  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

  • Receipt of medications intended to prevent COVID-19.

  • Prior receipt of more than 2 doses of BNT162b2 30 µg.

  • Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days 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.

Substudy D

Inclusion Criteria:
  • Male or female participants 18 to 55 years of age inclusive

  • 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Cohort 2: Participants who provided a serum sample at Visit 3 in Study C4591001, with Visit 3 occurring within the protocol-specified window.

  • Capable of giving signed informed consent

  • Cohort 1: Participants who have received 2 prior doses of 30 µg BNT162b2, with the second dose being 90 to 240 days before Visit 401 (Day 1) or Cohort 2: Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being 90 to 180 days before Visit 401 (Day 1).

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.

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

  • 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.

  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • 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.

  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

  • Cohorts 1 and 2: prior receipt of any COVID-19 vaccine other than BNT162b2.

  • Cohort 3 only: prior receipt of any COVID-19 vaccine.

  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

  • Receipt of medications intended to prevent COVID 19.

  • Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days 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.

Substudy E

Inclusion Criteria:
  • Male or female participants >55 years of age

  • 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Capable of giving signed informed consent.

  • Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being 5 to 12 months before Visit 601 (Day 1).

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.

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

  • 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.

  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • 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.

  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

  • Prior receipt of any COVID-19 vaccine other than BNT162b2.

  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

  • Receipt of medications intended to prevent COVID-19.

  • Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days 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.

Substudy F

Inclusion Criteria:
  • Male or female participants ≥60 years of age

  • 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

  • Capable of giving signed informed consent.

  • Participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being ≥4 months before Visit 701 (Day 1).

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.

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

  • 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.

  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

  • 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.

  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.

  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.

  • Prior receipt of any COVID-19 vaccine other than BNT162b2.

  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

  • Receipt of medications intended to prevent COVID-19.

  • Participation in other studies involving study intervention within 28 days prior to study entry through and including 28 days 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1North Alabama Research CenterAthensAlabamaUnited States35611
2Accel Research Sites ? Birmingham Clinical Research UnitBirminghamAlabamaUnited States35216
3Medical Affiliated Research Center (MARC)HuntsvilleAlabamaUnited States35801
4Alliance for Multispecialty Research, LLCMobileAlabamaUnited States36608
5Johns Hopkins Center for American Indian HealthChinleArizonaUnited States86503
6Hope Research InstitutePhoenixArizonaUnited States85018
7The Pain Center of ArizonaPhoenixArizonaUnited States85018
8HOPE Research InstitutePhoenixArizonaUnited States85023
9Alliance for Multispecialty Research, LLCTempeArizonaUnited States85281
10Johns Hopkins Center for American Indian HealthWhiteriverArizonaUnited States85941
11Whiteriver Indian Hospital- Garrett BuildingWhiteriverArizonaUnited States85941
12Whiteriver Indian HospitalWhiteriverArizonaUnited States85941
13Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
14Collaborative Neuroscience Research, LLC. - Investigator Site File LocationGarden GroveCaliforniaUnited States92845
15Collaborative Neuroscience Research, LLCLong BeachCaliforniaUnited States90806
16Kaiser Permanente Los Angeles Medical CenterLos AngelesCaliforniaUnited States90027
17Kaiser Permenente Medical Center Infectious DiseaseLos AngelesCaliforniaUnited States90027
18Velocity Clinical Research, WestlakeLos AngelesCaliforniaUnited States90057
19Velocity Clinical Research, North HollywoodNorth HollywoodCaliforniaUnited States91606
20Kaiser Permanente OaklandOaklandCaliforniaUnited States94611
21Paradigm Clinical Research Centers, IncReddingCaliforniaUnited States96001
22UC Davis Medical CenterSacramentoCaliforniaUnited States95817
23California Research FoundationSan DiegoCaliforniaUnited States92123
24Kaiser Permanente Santa ClaraSanta ClaraCaliforniaUnited States95051
25Bayview Research Group, LLCValley VillageCaliforniaUnited States91607
26Diablo Clinical Research, Inc.Walnut CreekCaliforniaUnited States94598
27Lynn Institute of DenverAuroraColoradoUnited States80012
28Clinical Research ConsultingMilfordConnecticutUnited States06460
29Yale University School of MedicineNew HavenConnecticutUnited States06510
30Yale-New Haven HospitalNew HavenConnecticutUnited States06511
31Yale Center for Clinical InvestigationNew HavenConnecticutUnited States06519
32Alliance for Multispecialty Research, LLCCoral GablesFloridaUnited States33134
33Indago Research & Health Center, IncHialeahFloridaUnited States33012
34Research Centers of America ( Hollywood )HollywoodFloridaUnited States33024
35Jacksonville Center for Clinical ResearchJacksonvilleFloridaUnited States32216
36Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonvilleFloridaUnited States32256
37Acevedo Clinical Research AssociatesMiamiFloridaUnited States33142
38Clinical Neuroscience SolutionsOrlandoFloridaUnited States32801
39IACT HealthColumbusGeorgiaUnited States31904
40Meridian Clinical Research, LLCSavannahGeorgiaUnited States31406
41Clinical Research AtlantaStockbridgeGeorgiaUnited States30281
42East-West Medical Research InstituteHonoluluHawaiiUnited States96814
43Solaris Clinical ResearchMeridianIdahoUnited States83646
44University of IowaIowa CityIowaUnited States52242
45Meridian Clinical Research, LLCSioux CityIowaUnited States51106
46Alliance for Multispecialty Research, LLCNewtonKansasUnited States67114
47Alliance for Multispecialty Research, LLCWichitaKansasUnited States67207
48Kentucky Pediatric/ Adult ResearchBardstownKentuckyUnited States40004
49Ochsner Clinic FoundationNew OrleansLouisianaUnited States70121
50Louisiana State University Health Sciences ShreveportShreveportLouisianaUnited States71101
51Johns Hopkins Bayview Medical CenterBaltimoreMarylandUnited States21224
52Boston Medical CenterBostonMassachusettsUnited States02118
53Investigational Pharmacy ServiceBostonMassachusettsUnited States02118
54University of Massachusetts Medical SchoolWorcesterMassachusettsUnited States01655
55Michigan Center of Medical Research (MICHMER)Farmington HillsMichiganUnited States48334
56MedPharmics, LLCGulfportMississippiUnited States39503
57Clinical Research ProfessionalsChesterfieldMissouriUnited States63005
58Sundance Clinical ResearchSaint LouisMissouriUnited States63141
59Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical ResearchBozemanMontanaUnited States59715
60Bozeman Health Deaconess HospitalBozemanMontanaUnited States59715
61Methodist Physicians Clinic/CCT ResearchFremontNebraskaUnited States68025
62Meridian Clinical ResearchNorfolkNebraskaUnited States68701
63Quality Clinical ResearchOmahaNebraskaUnited States68114
64Meridian Clinical Research LLCOmahaNebraskaUnited States68134
65Clinical Research Center of NevadaLas VegasNevadaUnited States89104
66Wake Research - Clinical Research Center of Nevada, LLCLas VegasNevadaUnited States89104
67Amici Clinical Research LLCRaritanNew JerseyUnited States08869
68South Jersey Infectious DiseaseSomers PointNew JerseyUnited States08244
69Gallup Indian Medical CenterGallupNew MexicoUnited States87301
70Johns Hopkins Center for American Indian HealthGallupNew MexicoUnited States87301
71Johns Hopkins Center for American Indian HealthShiprockNew MexicoUnited States87420
72Northern Navajo Medical CenterShiprockNew MexicoUnited States87420
73Meridian Clinical Research LLCBinghamtonNew YorkUnited States13901
74Meridian Clinical Research, LLCEndwellNew YorkUnited States13760
75NYU Langone HealthNew YorkNew YorkUnited States10016
76Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States10029
77Rochester Clinical Research, Inc.RochesterNew YorkUnited States14609
78Rochester General Hospital Infectious DiseaseRochesterNew YorkUnited States14621
79SUNY Upstate Medical UniversitySyracuseNew YorkUnited States13215
80AccellacareCaryNorth CarolinaUnited States27518
81AccellacareCharlotteNorth CarolinaUnited States28209
82Duke Clinical Research Pickett RoadDurhamNorth CarolinaUnited States27705
83PharmQuestGreensboroNorth CarolinaUnited States27408
84AccellacareHickoryNorth CarolinaUnited States28601
85AccellacareRaleighNorth CarolinaUnited States27609
86M3-Emerging Medical ResearchRaleighNorth CarolinaUnited States27612-8104
87Accellacare - SalisburySalisburyNorth CarolinaUnited States28144
88Accellacare (formerly PMG Research of Wilmington, LLC)WilmingtonNorth CarolinaUnited States28401
89AccellacareWilmingtonNorth CarolinaUnited States28401
90AccellacareWinston-SalemNorth CarolinaUnited States27103
91Lillestol ResearchFargoNorth DakotaUnited States58104
92Cincinnati Children's Hospital Medical CenterCincinnatiOhioUnited States45206
93Sterling Research Group - Mt. AuburnCincinnatiOhioUnited States45219
94Sterling Research Group, Ltd.CincinnatiOhioUnited States45219
95Cincinnati Children's Hospital Medical CenterCincinnatiOhioUnited States45229
96Sterling Research Group, Ltd.CincinnatiOhioUnited States45246
97University Hospitals Cleveland Medical CenterClevelandOhioUnited States44106
98VA Northeast Ohio Healthcare SystemClevelandOhioUnited States44106
99Velocity Clinical Research, ClevelandClevelandOhioUnited States44122
100Aventiv Research IncColumbusOhioUnited States43213
101Dayton Clinical ResearchDaytonOhioUnited States45406
102PriMED Clinical ResearchDaytonOhioUnited States45419
103Senders PediatricsSouth EuclidOhioUnited States44121
104Lynn Institute of NormanNormanOklahomaUnited States73072
105Kaiser Permanente Center for Health ResearchPortlandOregonUnited States97227
106Lehigh Valley Health Network/Network Office of Research and InnovationAllentownPennsylvaniaUnited States18102
107Velocity Clinical Research, ProvidenceEast GreenwichRhode IslandUnited States02818
108Main Street Physician's CareLittle RiverSouth CarolinaUnited States29566
109Holston Medical GroupBristolTennesseeUnited States37620
110Holston Medical GroupKingsportTennesseeUnited States37660
111Alliance for Multispecialty Research - Weisgarber Medical ParkKnoxvilleTennesseeUnited States37909
112Clinical Neuroscience Solutions, Inc. dba CNS HealthcareMemphisTennesseeUnited States38119
113Clinical Research Associates IncNashvilleTennesseeUnited States37203
114Trinity Clinical ResearchTullahomaTennesseeUnited States37388
115Benchmark ResearchAustinTexasUnited States78705
116ARC Clinical Research at Wilson ParkeAustinTexasUnited States78726
117Tekton Research, Inc.AustinTexasUnited States78745
118North Texas Infectious Diseases Consultants, P.ADallasTexasUnited States75246
119Ventavia Research GroupFort WorthTexasUnited States76104
120Benchmark ResearchFort WorthTexasUnited States76135
121HG PediatricsHoustonTexasUnited States77008
122Renu Garg, MD PediatricsHoustonTexasUnited States77008
123Van Tran Family PracticeHoustonTexasUnited States77008
124Ventavia Research Group, LLCHoustonTexasUnited States77008
125Texas Center for Drug Development, Inc.HoustonTexasUnited States77081
126Ventavia Research GroupKellerTexasUnited States76248
127SMS Clinical ResearchMesquiteTexasUnited States75149
128LinQ Research, LLCPearlandTexasUnited States77584
129Clinical Trials of Texas, Inc.San AntonioTexasUnited States78229
130Clinical Trials of Texas, LLCSan AntonioTexasUnited States78229
131Diagnostics Research GroupSan AntonioTexasUnited States78229
132DM Clinical ResearchTomballTexasUnited States77375
133J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake CityUtahUnited States84109
134J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake CityUtahUnited States84121
135Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)AnnandaleVirginiaUnited States22003
136Virginia Research CenterMidlothianVirginiaUnited States23114
137Benaroya Research Institute at Virginia MasonSeattleWashingtonUnited States98101
138Wenatchee Valley HospitalWenatcheeWashingtonUnited States98801
139Obras Sociais Irma DulceSalvadorBahiaBrazil40.415-000
140CEPIC - Centro Paulista de Investigação ClínicaSão PauloBrazil04266-010
141MIC Medial Imaging ConsultantsEdmontonAlbertaCanadaT5H 4B9
142BCRT - Berliner Centrum fuer Reise - und TropenmedizinBerlinGermany10117
143Sheba Medical CenterRamat GanHamerkazIsrael5265601
144Synergy Biomed Research InstituteEast LondonEastern CAPESouth Africa5201
145Worthwhile Clinical TrialsBenoniGautengSouth Africa1501
146Newtown Clinical ResearchJohannesburgGautengSouth Africa2113
147Clinresco CentresKempton ParkGautengSouth Africa1619
148Dr A Jacovides & Partners Inc.MidrandGautengSouth Africa1685
149Botho Ke Bontle Health Services PTY LTDPretoriaGautengSouth Africa0122
150Limpopo Clinical Research InitiativeThabazimbiLimpopoSouth Africa0380
151TREAD ResearchCape TownWestern CAPESouth Africa7500
152Tiervlei Trial CentreCape TownWestern CAPESouth Africa7530
153Jongaie ResearchPretoriaSouth Africa0183

Sponsors and Collaborators

  • BioNTech SE
  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
BioNTech SE
ClinicalTrials.gov Identifier:
NCT04955626
Other Study ID Numbers:
  • C4591031
  • 2021-005197-25
First Posted:
Jul 9, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by BioNTech SE
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022