Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
- Conditions
- Influenza
- Interventions
- Biological: Trivalent inactivated influenza vaccine
- Registration Number
- NCT00570037
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 544
- Mother of a newborn delivered at either Durham Regional Hospital or Duke University Hospital between October 2007 and February 2008
- Fetal demise or stillbirth
- Maternal rights relinquished
- Language barrier
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immunization Program Trivalent inactivated influenza vaccine Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders
- Primary Outcome Measures
Name Time Method Influenza Vaccine Coverage (Percent) for New Mothers of Newborns Pregnancy period through 6 to 8 weeks postpartum The percent of new mothers delivering at the hospital who reported receiving an influenza vaccine during their pregnancy, in the hospital after delivery, or during the 6 to 8 week postpartum period
Influenza Vaccine Coverage (Percent) for New Fathers of Newborns Pregnancy period through 6 to 8 weeks postpartum The percent of new fathers who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby
Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns Pregnancy period through 6 to 8 weeks postpartum The percent of all household contacts of newborns who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Durham Regional Hospital
🇺🇸Durham, North Carolina, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States