Summary

Eligibility
for people ages 16 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
estimated completion

Description

Summary

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

Official Title

A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162B2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162B2

Keywords

SARS-CoV-2 Infection COVID-19 Coronavirus Vaccine SARS-CoV-2 RNA Vaccine BNT162b2

Eligibility

You can join if…

Open to people ages 16 years and up

  • 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).

You CAN'T join if...

  • 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 during study participation.

Locations

  • University of California Davis Health accepting new patients
    Sacramento California 95817 United States
  • California Research Foundation accepting new patients
    San Diego California 92123 United States
  • Bayview Research Group, LLC accepting new patients
    Valley Village California 91607 United States
  • Providence Clinical Research accepting new patients
    North Hollywood California 91606 United States
  • Kaiser Permanente Infectious Disease accepting new patients
    Los Angeles California 90027 United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles California 90027 United States
  • National Research Institute ? Wilshire accepting new patients
    Los Angeles California 90057 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioNTech SE
ID
NCT04955626
Phase
Phase 3
Study Type
Interventional
Last Updated