Feasibility of Cocooning Immunization Strategy With Influenza Vaccine (Piiitch)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00570037
First received: December 7, 2007
Last updated: June 17, 2013
Last verified: January 2011
  Purpose

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.


Condition Intervention
Influenza
Biological: Trivalent inactivated influenza vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Influenza in Infants by Immunization of Their Contacts in the Household

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Influenza Vaccine Coverage (Percent) for New Mothers of Newborns [ Time Frame: Pregnancy period through 6 to 8 weeks postpartum ] [ Designated as safety issue: No ]
    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

  • Influenza Vaccine Coverage (Percent) for New Fathers of Newborns [ Time Frame: Pregnancy period through 6 to 8 weeks postpartum ] [ Designated as safety issue: No ]
    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

  • Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns [ Time Frame: Pregnancy period through 6 to 8 weeks postpartum ] [ Designated as safety issue: No ]
    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


Enrollment: 544
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immunization Program
Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders
Biological: Trivalent inactivated influenza vaccine
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
Other Name: Fluzone
No Intervention: No Immunization Program
Comparison Hospital - Receipt of vaccine through routine clinical care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570037

Locations
United States, North Carolina
Durham Regional Hospital
Durham, North Carolina, United States, 27704
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Emmanuel B Walter, MD, MPH Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00570037     History of Changes
Other Study ID Numbers: Pro00004990, 1 U01 IP000074-01
Study First Received: December 7, 2007
Results First Received: October 6, 2010
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Influenza
Vaccine
Children

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014