Influenza Clinical Trial
— PiiitchOfficial title:
Prevention of Influenza in Infants by Immunization of Their Contacts in the Household
Verified date | January 2011 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 544 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
United States | Durham Regional Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Centers for Disease Control and Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
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