Status:
TERMINATED
Trial of Antibody Responses by Vitamin Supplementation
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
The Gerber Foundation
Conditions:
Healthy Participants
Eligibility:
All Genders
1-4 years
Phase:
PHASE1
Brief Summary
Streptococcus pneumoniae, commonly called pneumococcus, can cause a wide range of diseases in children from mild ear infections to deadly pneumonia or meningitis. Vaccination is currently the single b...
Detailed Description
Children between the ages of 1 and 4 years old (inclusive) will be enrolled. All will receive PCV and hepatitis A vaccination. Those randomized to the treatment arm will receive 10,000 IU orally at th...
Eligibility Criteria
Inclusion
- Between 1 and 4 years old (inclusive) at the time of enrollment
- Fully weaned from breast-feeding or formula-feeding for at least 4 weeks prior to vaccination date (Day 0).
- Received at least 2 doses of Prevnar-13 vaccination
- Parent or legal guardian willing and able to provide informed consent.
Exclusion
- Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment
- Parent/guardian planning to continue (or initiate) the administration of daily vitamin A, vitamin D, or multivitamin to the child during the study period.
- Evidence of developmental delay or evolving neurological disorders at screening.
- Current use of antibiotics or antivirals at enrollment.
- Currently receiving cancer related treatment.
- History of heart, kidney, or chronic respiratory condition (e.g., asthma) conditions.
- History of diabetes.
- Acute febrile illness \[e.g., \>100.0F (37.8oC) oral\] illness within 3 days prior to enrollment.
- Received a previous PCV13 vaccine within 2 months of the enrollment date (Day 0).
- Received hepatitis A vaccine previously.
- Ever had a life-threatening allergic reaction to a dose of PCV13 vaccine, to an earlier pneumococcal vaccine called PCV7, or to any vaccine containing diptheria toxoid (for example, DTaP).
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03859687
Start Date
August 19 2019
End Date
July 10 2025
Last Update
September 5 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105