drugset / Trial / NCT02649192

Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children

NCT02649192

Phase 2 Completed 87 enrolled St. Jude Children's Research Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A \& D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract. The central hypothesis of this protocol is that vitamin supplements will enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza virus vaccine with placebo. Children will be tested for vitamin levels and immune responses before and after influenza virus vaccinations to determine if vitamin supplementation improves the influenza virus vaccine-induced immune response. PRIMARY OBJECTIVE: * To assess the vaccine-induced and total antibody (including IgG and IgA) response after influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56 days in sera SECONDARY OBJECTIVE: * To assess the neutralizing response toward influenza virus vaccine in the sera.

Timeline

Start
2016-01-21
Primary completion
2018-06-29
Completion
2018-06-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Influenza Virus Vaccine Vaccine

Indications

No indication recorded.