A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
ConditionCOVID-19 Vaccines
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBioNTech SE
About this trial
The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age.
This study is seeking participants who:
* are medically stable * have not had a recent COVID-19 infection * have not had a recent vaccination * do not have medical conditions that increase their risk of complications from COVID-19
All participants in this study will randomly receive 1 injection into their arm of either:
* BNT162b2 vaccine which targets COVID-19 and is selected for the 2026-2027 COVID-19 season, or * Tdap vaccine which targets tetanus, diphtheria, and pertussis (whooping cough).
The study team and participants will not know which injection they receive. We will evaluate safety and SARS-CoV-2 spike protein levels in people receiving each of these vaccines.
Participants will be in the study for about 12 months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Participants who tested positive for COVID-19 within 6 months (180 days) prior to Visit 1
Participants who have recently received a vaccine, or plan to receive a nonstudy COVID-19 or comparator vaccine during participation.
Trial design
Design model
Parallel
Treatments tested in this trial
BNT162b2 Vaccine
Biological/VaccineParticipants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
Tdap Vaccine
Biological/VaccineParticipants will receive a single injection containing Tdap on Day 1.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: BNT162b2 VaccineExperimental treatment 1 intervention
Group B: Tdap VaccineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants reporting local reactions or systemic events
Time frame
From Day 1 up to 7 days after Vaccination2
Percentage of participants reporting adverse events
Time frame
From Day 1 through 1 month after vaccination3
Percentage of participants reporting serious adverse events
Time frame
From Day 1 through 12 months after vaccination4
Spike protein levels
Time frame
Up to 12 months after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
BioNTech SE
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov