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Feasibility of Cocooning Immunization Strategy With Influenza Vaccine (Piiitch)

This study has been completed.

Sponsors and Collaborators: Duke University
Centers for Disease Control and Prevention
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00570037
  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 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.


Condition Intervention
Influenza
Biological: Trivalent inactivated influenza vaccine
Other: Control

MedlinePlus related topics:   Flu   

ChemIDplus related topics:   Influenza Vaccines    Fluvirin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Parallel Assignment
Official Title:   Prevention of Influenza in Infants by Immunization of Their Contacts in the Household

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Influenza vaccine coverage rates for new mothers and household contacts of newborns [ Time Frame: Pregnancy through 6 weeks postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:   600
Study Start Date:   October 2007
Study Completion Date:   April 2008

Arms Assigned Interventions
1: Active Comparator
Intervention Hospital
Biological: Trivalent inactivated influenza vaccine
Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders
2: No Intervention
Control Hospital
Other: Control
Control, usual 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

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

Investigators
Principal Investigator:     Emmanuel B Walter, MD, MPH     Duke University Health System    
  More Information

Responsible Party:   Duke University Health System ( Emmanuel Walter MD, MPH (Principal Investigator) )
Study ID Numbers:   9436-07-2R0ER, 1 U01 IP000074-01
First Received:   December 7, 2007
Last Updated:   May 4, 2008
ClinicalTrials.gov Identifier:   NCT00570037
Health Authority:   United States: Institutional Review Board

Keywords provided by Duke University:
Influenza  
Vaccine  
Children  

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on August 28, 2008




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