Feasibility of Cocooning Immunization Strategy With Influenza Vaccine

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Influenza in Infants by Immunization of Their Contacts in the Household

Conditions
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Influenza

Intervention / Treatment
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* Biological: Trivalent inactivated influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mother of a newborn delivered at either Durham Regional Hospital or Duke University Hospital between October 2007 and February 2008 Exclusion Criteria: Fetal demise or stillbirth Maternal rights relinquished Language barrier

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immunization Program<br>Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders | Biological: Trivalent inactivated influenza vaccine<br>* Intramuscular injection, 0.5 mL or 0.25 mL depending on age of vaccine recipient, one or two doses administered a month apart depending on age and prior influenza vaccination history of recipient<br>* Other names: Fluzone;|
| No Intervention: No Immunization Program<br>Comparison Hospital - Receipt of vaccine through routine clinical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza Vaccine Coverage (Percent) for New Mothers of Newborns | 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 | Pregnancy period through 6 to 8 weeks postpartum | 
| Influenza Vaccine Coverage (Percent) for New Fathers of Newborns | 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 | Pregnancy period through 6 to 8 weeks postpartum | 
| Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns | 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 | Pregnancy period through 6 to 8 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, Children