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Feasibility of Cocooning Immunization Strategy With Influenza Vaccine (Piiitch)

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trivalent inactivated influenza vaccine
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, Children

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Durham Regional Hospital
  • Duke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Immunization Program

No Immunization Program

Arm Description

Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders

Comparison Hospital - Receipt of vaccine through routine clinical care

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
December 7, 2007
Last Updated
June 17, 2013
Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00570037
Brief Title
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
Acronym
Piiitch
Official Title
Prevention of Influenza in Infants by Immunization of Their Contacts in the Household
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccine, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immunization Program
Arm Type
Active Comparator
Arm Description
Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders
Arm Title
No Immunization Program
Arm Type
No Intervention
Arm Description
Comparison Hospital - Receipt of vaccine through routine clinical care
Intervention Type
Biological
Intervention Name(s)
Trivalent inactivated influenza vaccine
Other Intervention Name(s)
Fluzone
Intervention Description
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
Primary Outcome Measure Information:
Title
Influenza Vaccine Coverage (Percent) for New Mothers of Newborns
Description
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
Time Frame
Pregnancy period through 6 to 8 weeks postpartum
Title
Influenza Vaccine Coverage (Percent) for New Fathers of Newborns
Description
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
Time Frame
Pregnancy period through 6 to 8 weeks postpartum
Title
Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns
Description
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
Time Frame
Pregnancy period through 6 to 8 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel B Walter, MD, MPH
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Regional Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Feasibility of Cocooning Immunization Strategy With Influenza Vaccine

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