Feasibility of Cocooning Immunization Strategy With Influenza Vaccine (Piiitch)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00570037
First received: December 7, 2007
Last updated: January 9, 2011
Last verified: January 2011
Results First Received: October 6, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Trivalent inactivated influenza vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
October 2007 through February 2008 Post partum units of two Durham, North Carolina hospitals

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Hospital With Immunization Program No text entered.
Hospital With No Immunization Program No text entered.

Participant Flow:   Overall Study
    Hospital With Immunization Program     Hospital With No Immunization Program  
STARTED     238     306  
COMPLETED     194     237  
NOT COMPLETED     44     69  
Could not reach for 6-8 week contact                 44                 69  



  Baseline Characteristics
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Reporting Groups
  Description
Hospital With Immunization Program No text entered.
Hospital With No Immunization Program No text entered.
Total Total of all reporting groups

Baseline Measures
    Hospital With Immunization Program     Hospital With No Immunization Program     Total  
Number of Participants  
[units: participants]
  238     306     544  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     238     306     544  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     238     306     544  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     238     306     544  



  Outcome Measures
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1.  Primary:   Influenza Vaccine Coverage (Percent) for New Mothers of Newborns   [ Time Frame: Pregnancy period through 6 to 8 weeks postpartum ]

2.  Primary:   Influenza Vaccine Coverage (Percent) for New Fathers of Newborns   [ Time Frame: Pregnancy period through 6 to 8 weeks postpartum ]

3.  Primary:   Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns   [ Time Frame: Pregnancy period through 6 to 8 weeks postpartum ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Emmanuel Walter MD, Principal Investigator
Organization: Duke University Medical Center
phone: 919-620-5374
e-mail: walte002@mc.duke.edu


No publications provided


Responsible Party: Emmanuel Walter MD, MPH (Principal Investigator), Duke University Health System
ClinicalTrials.gov Identifier: NCT00570037     History of Changes
Other Study ID Numbers: 00004990, 1 U01 IP000074-01
Study First Received: December 7, 2007
Results First Received: October 6, 2010
Last Updated: January 9, 2011
Health Authority: United States: Institutional Review Board