Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
Trial status:Study Complete
Study Identifier:
C4591024
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Study Complete
Results available
Study Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Trial details
Medical Condition
Study Drug
Phase
Phase 2
Sex
Female & Male
Age
2+
Estimated Trial Date
Oct 2021 - Jul 2023
Protocol 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.
Trial locations
Location
Status
Location
Ochsner Clinic Foundation
Jefferson, Louisiana, United States, 70121
Status
Location
Ochsner Medical Center - Jefferson Highway
Jefferson, Louisiana, United States, 70121
Status
Location
Ochsner Clinic Foundation
Kenner, Louisiana, United States, 70065
Status
Location
Ochsner Medical Center Kenner
Kenner, Louisiana, United States, 70065
Status
Location
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Status
Location
Ochsner Medical Center - Jefferson Highway
New Orleans, Louisiana, United States, 70121
Status