Trial Outcomes & Findings for Feasibility of Cocooning Immunization Strategy With Influenza Vaccine (NCT NCT00570037)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

544 participants

Primary outcome timeframe

Pregnancy period through 6 to 8 weeks postpartum

Results posted on

2013-06-24

Participant Flow

October 2007 through February 2008 Post partum units of two Durham, North Carolina hospitals

Participant milestones

Participant milestones
Measure	Hospital With Immunization Program	Hospital With No Immunization Program
Overall Study STARTED	238	306
Overall Study COMPLETED	194	237
Overall Study NOT COMPLETED	44	69

Reasons for withdrawal

Reasons for withdrawal
Measure	Hospital With Immunization Program	Hospital With No Immunization Program
Overall Study Could not reach for 6-8 week contact	44	69

Baseline Characteristics

Feasibility of Cocooning Immunization Strategy With Influenza Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hospital With Immunization Program n=238 Participants	Hospital With No Immunization Program n=306 Participants	Total n=544 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	238 Participants n=5 Participants	306 Participants n=7 Participants	544 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	238 Participants n=5 Participants	306 Participants n=7 Participants	544 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	238 participants n=5 Participants	306 participants n=7 Participants	544 participants n=5 Participants

PRIMARY outcome

Timeframe: Pregnancy period through 6 to 8 weeks postpartum

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

Outcome measures

Outcome measures
Measure	Hospital With Immunization Program n=238 Participants	Hospital With No Immunization Program n=306 Participants
Influenza Vaccine Coverage (Percent) for New Mothers of Newborns	70 Percentage of Participants	64 Percentage of Participants

PRIMARY outcome

Timeframe: Pregnancy period through 6 to 8 weeks postpartum

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

Outcome measures

Outcome measures
Measure	Hospital With Immunization Program n=238 Participants	Hospital With No Immunization Program n=306 Participants
Influenza Vaccine Coverage (Percent) for New Fathers of Newborns	53 Percentage of Fathers of Newborns	26 Percentage of Fathers of Newborns

PRIMARY outcome

Timeframe: Pregnancy period through 6 to 8 weeks postpartum

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

Outcome measures

Outcome measures
Measure	Hospital With Immunization Program n=238 Participants	Hospital With No Immunization Program n=306 Participants
Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns	55 Percentage of All Household Contacts	39 Percentage of All Household Contacts

Adverse Events

Hospital With Immunization Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hospital With No Immunization Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emmanuel Walter MD, Principal Investigator

Duke University Medical Center

Phone: 919-620-5374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place