BIVAX: COVID-19 Pediatric Vaccine Study 

BIVAX: COVID-19 Pediatric Vaccine Study 

Categories:

Infectious Diseases

Healthy Volunteers

Diseases Treated:

COVID-19

Eligibility Overview:

  • 6 months to less than 5 years
  • In good health
  • Have not received a COVID-19 vaccine in the past

  1. About this study

    St. Jude is taking part in clinical trials to test COVID-19 prevention vaccines in healthy children. There is no cost to take part.

    This clinical trial will study COVID-19 vaccines that are being used in adults. 

    Steps of the clinical trial are:

    1. The clinical trial team will give your child a COVID-19 test by inserting a cotton swab into their nose. 
    2. The team will take blood samples to see if your child already has any COVID-19 antibodies in their system.
    3. Children in the study will be assigned at random to get either 2 or 3 doses of the vaccine. The vaccine does not contain the virus that causes COVID-19. Your child will not be exposed to COVID-19 as part of this study.
    4. After the vaccine shots are given, we will ask you and/or your child to keep a diary to track how your child feels. This will help us document any side effects. 

    Purpose of this clinical trial

    The purpose of this clinical trial is to test COVID-19 prevention vaccines in healthy children. We want to know if the vaccines have any side effects. 

    We encourage you to have conversations with family, health care providers, and the study team about taking part in a COVID-19 vaccine clinical trial and whether it is the right decision for your child. If you decide to have your child take part in the clinical trial, you can change your mind later at any time.

    Eligibility overview

    • Between 6 months and less than 5 years old

    • In good health

    • Have not received a COVID-19 vaccine in the past

  2. BIVAX  Quick View
    Sponsor BioNTech SE
    ClinicalTrials.gov identifier NCT05543616
    Trial start date September 2022
    Estimated enrollment 3,692 across all sites 
    Study type Interventional
    Conditions

    Healthy volunteers
    Ages 6 months - <5 years
    Site Principal Investigator Nehali Patel, MD
    Study site St. Jude Children’s Research Hospital and collaborating sites
    For a consultation or to discuss St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Nehali Patel, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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