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 control 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 and self report of the birth mothers. 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 control hospital. Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine will also be assessed.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Parallel Assignment

Intervention(s) in this Clinical Trial

• Biological: Trivalent inactivated influenza vaccine
  • Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders
• Other: Control
  • Control, usual care

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Intervention Hospital
• No Intervention: 2
  • Control Hospital

Primary Measures

• Influenza vaccine coverage rates for new mothers and household contacts of newborns
  • Time Frame: Pregnancy through 6 weeks postpartum
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Duke University

Overall Clinical Trial Officials and Contacts

Emmanuel B Walter, MD, MPH Principal Investigator Duke University Health System  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00570037

Study ID Number: 9436-07-2R0ER

ClinicalTrials.gov Identifier: NCT00570037

Health Authority: United States: Institutional Review Board