A Study of COVID-19 Vaccine(s) in Children and Adults
ConditionCOVID-19 Vaccines
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5+
SponsorBioNTech SE
About this trial
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 a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026/2027 recommended strain) injected in the upper arm. 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 upper 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BNT162b2
Biological/VaccineBNT162b2 vaccine 1 (2026/2027 recommended strain)
BNT162b2
Biological/VaccineBNT162b2 vaccine 2
BNT162b2
Biological/VaccineBNT162b2 vaccine 3
Treatment groups
700 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Cohort 1 Group 1: 5-11 Years (with risk factors)Experimental treatment 1 intervention
Group B: Cohort 1 Group 3: ≥65 YearsExperimental treatment 1 intervention
Group C: Cohort 1 Group 2: 12-64 Years (with risk factors)Experimental treatment 1 intervention
Group D: Cohort 2 Group 5: 18-64 Years (with risk factors)Experimental treatment 1 intervention
Group E: Cohort 2 Group 4: 18-64 Years (with risk factors)Experimental treatment 1 intervention
Group F: Cohort 2 Group 6: 18-64 Years (with risk factors)Experimental treatment 1 intervention
Group G: Cohort 2 Group 7: ≥65 YearsExperimental treatment 1 intervention
Group H: Cohort 2 Group 8: ≥65 YearsExperimental treatment 1 intervention
Group I: Cohort 2 Group 9: ≥65 YearsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants reporting local reactions or systemic events
Time frame
For up to 7 days after vaccination2
Percentage of participants reporting adverse events
Time frame
Through 1 month after vaccination3
Percentage of participants reporting serious adverse events
Time frame
Through 6 months after vaccination4
Geometric Mean Fold Rise (GMFRs)
Time frame
From baseline to 1 month after vaccinationSecondary outcomes
1
Geometric Mean Titers (GMTs)
Time frame
At baseline and at 1 month after vaccination2
Percentage of participants with seroresponse
Time frame
At 1 month after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
BioNTech SE
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov