Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years

Trial status:Study Complete
Trial ID:
C4591024
NCT ID:
EudraCT ID:
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

Trial Details

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.

Medical Condition
  • COVID-19
  • Trial Drug
  • BNT162b2
  • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    124
    Estimated Trial Date
    Oct 2021 - Jul 2023

    Trial Participant Requirements

    Age
    2+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    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