EICHORCondition: SARS-CoV-2 Virus · Severe Acute Respiratory Syndrome Coronavirus 2 · COVID-19 · Sponsor: BioNTech SE
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. * Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. * Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. * Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses…
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
| UAB Child Health Research Unit (CHRU) | Birmingham, Alabama, United States | — |
| Phoenix Children's Hospital | Phoenix, Arizona, United States | — |
| Advanced Research Center Inc. | Anaheim, California, United States | — |
| Kaiser Permanente | Los Angeles, California, United States | — |
| Kaiser Permanente Oakland | Oakland, California, United States | — |
| Stanford University Medical Center | Palo Alto, California, United States | — |
| Center for Clinical Trials, LLC | Paramount, California, United States | — |
| Peninsula Research Associates | Rolling Hills Estates, California, United States | — |
| Kaiser Permanente Sacramento | Sacramento, California, United States | — |
| PediaClinic | Highlands Ranch, Colorado, United States | — |
| Yale University School of Medicine | New Haven, Connecticut, United States | — |
| Yale University- Yale Center for Clinical Investigation | New Haven, Connecticut, United States | — |
+ 84 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05543616