COVID-19 Vaccines
Conditions
Keywords
Pneumonia, Respiratory Tract Infections, Pneumonia,Viral, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19, mRNA Vaccines, Nucleic Acid-Based Vaccine, Vaccines, Synthetic, Recombinant Proteins, Proteins, Amino Acids, Peptides, and Proteins, Vaccines, Biological Products, COVID-19 Vaccines, Viral Vaccines, Antigens, Biological Factors, BNT162 Vaccine
Brief summary
The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older. This study is seeking participants who: * are medically stable * have not had a recent COVID-19 infection or a recent COVID-19 vaccination * have not received certain routine vaccines recently * participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19. Participants in Cohort 1 of this study will receive 1 injection into their arm of BNT162b2 vaccine 1 which targets COVID-19. The study team and participants will know which injection they receive. Participants in Cohort 2 of this study will randomly receive 1 injection into their arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive. Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.
Interventions
BIOLOGICALBNT162b2
BNT162b2 vaccine 1
Sponsors
BioNTech SE
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Cohort 1 - No Masking; Cohort 2 - Masking applies: Double Blind, Third-party Unblinded (Participant, Care Provider, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion criteria: * Participants 5 years of age or older. * Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19. Key
Exclusion criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). * History of myocarditis or pericarditis. * Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment. Refer to the study contact for further eligibility details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants reporting serious adverse events | Through 6 months after vaccination |
| Geometric Mean Fold Rise (GMFRs) | From baseline to 1 month after vaccination |
| Percentage of participants reporting local reactions or systemic events | For up to 7 days after vaccination |
| Percentage of participants reporting adverse events | Through 1 month after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Titers (GMTs) | At baseline and at 1 month after vaccination |
| Percentage of participants with seroresponse | At 1 month after vaccination |
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed