A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BNT162b2 Vaccine, Tdap Vaccine.
- Who it may be relevant to
- Registry conditions: COVID-19 Vaccines. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE
Overview
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.
Interventions
- Biological BNT162b2 Vaccine
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1. - Biological Tdap Vaccine
Participants will receive a single injection containing Tdap on Day 1.
Primary outcome measures
- Percentage of participants reporting local reactions or systemic events [Time frame: From Day 1 up to 7 days after Vaccination]
- Percentage of participants reporting adverse events [Time frame: From Day 1 through 1 month after vaccination]
- Percentage of participants reporting serious adverse events [Time frame: From Day 1 through 12 months after vaccination]
- Spike protein levels [Time frame: Up to 12 months after vaccination]
Eligibility criteria
Inclusion criteria
\- Healthy participants 18 through 64 years of age who do not have medical conditions that put them at a higher risk for severe COVID-19.
Exclusion criteria
- 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.
The complete list of inclusion and exclusion criteria are listed in the protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 5 centers
- Diablo Clinical Research, LLC dba Flourish Research — Walnut Creek
- Palm Springs Community Health Center — Miami Lakes
- East-West Medical Research Institute — Honolulu
- Duke Vaccine and Trials Unit — Durham
- J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City
Identifiers
NCT: NCT07730450 · C4591088