Influenza Clinical Trial
Official title:
Prevention of Influenza in Infants by Immunization of Their Contacts in the Household
Influenza causes epidemics of respiratory infection in young children each winter. Young
children, particularly those under 6 months of age are most vulnerable to suffering from
complications secondary to influenza infection. Consequently, influenza vaccine has been
recommended for children 6-59 months of age. Influenza vaccine is not approved for use in
children under 6 month of age who are at highest risk. Therefore, the Centers for Disease
Control and Prevention Advisory Committee on Immunization Practices has recommended
vaccination of household contacts of children under 6 month of age - a cocooning strategy.
The current study is a hospital-based study to assess the effectiveness of a program to
vaccinate birth mothers and household contacts of newborns with influenza vaccine. We
propose to study both birth mothers and household contacts of newborns delivered at Durham
Regional Hospital and Duke University Medical Center, birthing hospitals serving Durham and
surrounding counties in central North Carolina. We will implement several strategies to
increase vaccine coverage rates at Durham Regional Hospital utilizing Duke University
Hospital as a comparison setting. Strategies will include: standing vaccine orders for birth
mothers, vaccine reminders for household contacts, and a hospital based influenza vaccine
clinic to increase vaccine accessibility for household contacts. Vaccine coverage rates will
be assessed utilizing a survey method (maternal interview at the birthing hospital and a
follow-up telephone contact 6-8 weeks later). We hypothesize that influenza vaccine coverage
rates for new mothers and household contacts of newborns delivered at the intervention
hospital will be higher when compared to coverage rates in the comparison hospital.
Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine
will also be assessed.
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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