N/A
N=544
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00570037 ↗Enrolled (actual)
544
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Influenza Vaccine Coverage (Percent) for New Mothers of Newborns — 70; 64 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trivalent inactivated influenza vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Influenza Vaccine Coverage (Percent) for New Mothers of Newborns |
70; 64 | — |
| PRIMARY Influenza Vaccine Coverage (Percent) for New Fathers of Newborns |
53; 26 | — |
| PRIMARY Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns |
55; 39 | — |
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
Data sourced from ClinicalTrials.gov (NCT00570037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.