Study to Evaluate the Safety and Efficacy of a Booster Dose of BNT162b2 Against COVID-19 in Participants ≥16 Years of Age.
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
- SARS-CoV-2 Infection
- Eligible Ages
- Over 16 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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).
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
- BioNTech SE
Study ContactPfizer CT.gov Call Center