Trials / Completed
CompletedNCT04895982
Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- BioNTech SE · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Participants are going to be followed up for 6 months after dose 4, and each participant is projected to be on the study for approximately 15 months. This study will be conducted in the United States, Brazil, Germany and Mexico.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BNT162b2 | Intramuscular Injection |
Timeline
- Start date
- 2021-10-15
- Primary completion
- 2023-07-23
- Completion
- 2023-07-23
- First posted
- 2021-05-21
- Last updated
- 2024-10-09
- Results posted
- 2024-10-09
Locations
29 sites across 4 countries: United States, Brazil, Germany, Mexico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04895982. Inclusion in this directory is not an endorsement.