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

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT02649192

Run by

St. Jude Children's Research Hospital

People needed

87

Starts

2016-01-21

Expected to finish

2018-06-29

Last updated by the study team

2019-10-29

Who can join

Age: 2 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Resident of the Memphis area community.
• Parent or legal guardian willing and able to give informed consent and comply with study requirements.

You may not qualify if…

• Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment.
• Currently taking a daily (routine) vitamin A, D, or multivitamin. Note: participants who report occasional or sporadic vitamin use will be allowed to enroll.
• History of lung disease, asthma, immunodeficiency, sickle cell disease, or any other serious underlying condition or disease in the opinion of the principal investigator.
• Evidence of developmental delay or evolving neurological disorders at screening. Current use of antibiotics or antivirals at enrollment.
• History of having a severe allergy to eggs or to any inactive ingredient in the influenza virus vaccine
• History of a life-threatening reaction to influenza vaccinations
• Currently wheezing at the time of enrollment
• History of heart, kidney, or lung conditions
• History of diabetes
• Use of an anti-influenza medication (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment
• Acute febrile [>100.0°F (37.8°C) oral] illness or acute respiratory illness (e.g., cough or sore throat) within 3 days prior to enrollment
• Previous receipt of current seasonal influenza vaccine

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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