Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
NCT ID: NCT02649192 Phase: PHASE2 Status: COMPLETED Enrollment: 87 Completion: 2018-06-29
Conditions
Healthy Participants
Interventions
Influenza virus vaccine, Vitamins A and D, Placebo
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.
Primary Outcome
Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera