Feasibility of Cocooning Immunization Strategy With Influenza Vaccine (Piiitch)

This study has been completed.

Sponsor:

Collaborator:

Centers for Disease Control and Prevention

Information provided by:

Duke University

ClinicalTrials.gov Identifier:

NCT00570037

First received: December 7, 2007

Last updated: January 9, 2011

Last verified: January 2011

History of Changes

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

Hide Participant Flow

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
No text entered.

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

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Primary:

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

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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

To Top