Full Text View
Tabular View
No Study Results Posted
Related Studies
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine (Piiitch)
This study has been completed.
Study NCT00570037   Information provided by Duke University
First Received: December 7, 2007   Last Updated: May 4, 2008   History of Changes

December 7, 2007
May 4, 2008
October 2007
 
Influenza vaccine coverage rates for new mothers and household contacts of newborns [ Time Frame: Pregnancy through 6 weeks postpartum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00570037 on ClinicalTrials.gov Archive Site
 
 
 
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
Prevention of Influenza in Infants by Immunization of Their Contacts in the Household

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.

 
 
Interventional
Prevention, Non-Randomized, Open Label, Parallel Assignment
Influenza
  • Biological: Trivalent inactivated influenza vaccine
  • Other: Control
  • Active Comparator: Intervention Hospital
  • No Intervention: Control Hospital
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
600
April 2008
 

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00570037
Emmanuel Walter MD, MPH (Principal Investigator), Duke University Health System
9436-07-2R0ER, 1 U01 IP000074-01
Duke University
Centers for Disease Control and Prevention
Principal Investigator: Emmanuel B Walter, MD, MPH Duke University Health System
Duke University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP