Clinical trial NCT00570037: Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
Official title: Prevention of Influenza in Infants by Immunization of Their Contacts in the Household
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
Vaccine
Children
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-12-10
Enrollment: 544
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Influenza Vaccine Coverage (Percent) for New Mothers of Newborns
timeFrame: Pregnancy period through 6 to 8 weeks postpartum
measure: Influenza Vaccine Coverage (Percent) for New Fathers of Newborns
timeFrame: Pregnancy period through 6 to 8 weeks postpartum
measure: Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns
timeFrame: Pregnancy period through 6 to 8 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke Health
name: Emmanuel B Walter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: