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Trial record 30 of 597 for:    Fluzone® | Studies With Results

Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

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ClinicalTrials.gov Identifier: NCT00812110
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : January 23, 2013
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Drug: Influenzae vaccine
Enrollment 336

Recruitment Details During the 2008-2009 influenza season, 474 caregivers were approached. 292 agreed to participate,and had not received influenza vaccine.
Pre-assignment Details  
Arm/Group Title Caregivers
Hide Arm/Group Description Caregivers of children at high risk, per CDC definitions, of complications of influenza.
Period Title: Overall Study
Started 292
Completed 292
Not Completed 0
Arm/Group Title Caregivers
Hide Arm/Group Description Caregivers of children at high risk, per CDC definitions, of complications of influenza.
Overall Number of Baseline Participants 292
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 292 participants
30.5  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants
Female
235
  80.5%
Male
57
  19.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
171
  58.6%
White
100
  34.2%
More than one race
0
   0.0%
Unknown or Not Reported
21
   7.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 292 participants
292
1.Primary Outcome
Title Number of Participants Who Received Influenza Vaccine.
Time Frame 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caregivers
Hide Arm/Group Description:
Caregivers of children at risk for complications of influenza
Overall Number of Participants Analyzed 292
Measure Type: Number
Unit of Measure: participants
250
2.Secondary Outcome
Title Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
Hide Description Number of participants who received influenza vaccine the prior year.
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caregivers
Hide Arm/Group Description:
Caregivers of children at risk for complications of influenza
Overall Number of Participants Analyzed 292
Measure Type: Number
Unit of Measure: participants
69
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Caregivers
Hide Arm/Group Description Caregivers of children at high risk, per CDC definitions, of complications of influenza.
All-Cause Mortality
Caregivers
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Caregivers
Affected / at Risk (%)
Total   0/292 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caregivers
Affected / at Risk (%)
Total   0/292 (0.00%) 
Exclusively urban,lower socioeconomic status population limits external generalizability. Study was uncontrolled; historical controls were referenced instead. Baseline vaccination rates were self-reported. Possible bias in at-risk determination.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: P. Cooper White, M.D.
Organization: Akron Children's Hospital
Phone: 330-543-8530
Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00812110     History of Changes
Other Study ID Numbers: 081105
First Submitted: December 18, 2008
First Posted: December 19, 2008
Results First Submitted: October 31, 2011
Results First Posted: January 23, 2013
Last Update Posted: January 23, 2013