Trial Outcomes & Findings for A Study to Describe Pediatric Influenza Vaccine Coverage (NCT NCT00639418)

Results Overview

Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice's care in that specific age group.

Recruitment status

COMPLETED

Target enrollment

147494 participants

Primary outcome timeframe

Seasonal: 2007-2011

Results posted on

2014-09-15

Participant Flow

This study of 118 physician offices in the USA identified the number of patients per practice by age group. A baseline survey and semi-monthly surveys of number of influenza vaccination doses given, staff attitudes toward influenza vaccination, and activities to increase influenza vaccination coverage were completed.

While a total of 147494 children were vaccinated in participating physicians' offices, no subjects were actually treated in this observational study.

Participant milestones

Participant milestones
Measure	Participants 6 to 23 Months Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age	Participants 24 to 59 Months Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age	Participants 5 to 8 Years Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age	Participants 9 to 18 Years Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
Overall Study STARTED	28101	35967	36496	46930
Overall Study COMPLETED	28101	35967	36496	46930
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Describe Pediatric Influenza Vaccine Coverage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=147494 Participants Total of all reporting groups	Participants 6 to 23 Months n=28101 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age	Participants 24 to 59 Months n=35967 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age	Participants 5 to 8 Years n=36496 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age	Participants 9 to 18 Years n=46930 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
Age, Customized	147494 participants n=21 Participants	28101 participants n=5 Participants	35967 participants n=7 Participants	36496 participants n=5 Participants	46930 participants n=4 Participants
Sex: Female, Male Female	NA Participants n=21 Participants	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Sex: Female, Male Male	NA Participants n=21 Participants	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants

PRIMARY outcome

Timeframe: Seasonal: 2007-2011

Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice's care in that specific age group.

Outcome measures

Outcome measures
Measure	Participants 6 to 23 Months n=28101 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age	Participants 24 to 59 Months n=35967 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age	Participants 5 to 8 Years n=36496 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age	Participants 9 to 18 Years n=46930 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices	46.5 percentage of participants	30.9 percentage of participants	30.6 percentage of participants	19.4 percentage of participants

SECONDARY outcome

Timeframe: Seasonal: 2007-2011

Compliance was calculated from the total number of participants receiving 2 doses divided by the total number of participants identified as requiring a second dose.

Outcome measures

Outcome measures
Measure	Participants 6 to 23 Months n=28101 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age	Participants 24 to 59 Months n=35967 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age	Participants 5 to 8 Years n=36496 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age	Participants 9 to 18 Years n=46930 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
Compliance With the Recommended Two-dose Regimen in Vaccinated Participants	67.5 percentage of participants	42.7 percentage of participants	40.8 percentage of participants	NA percentage of participants Compliance was not calculated for this age group as 2 doses are not required.

SECONDARY outcome

Timeframe: Seasonal: 2007-2011

Correlation of office attitudes related to influenza vaccination and actual vaccine coverage was explored. Sites were asked to indicate level of agreement with the following recommendations: vaccinating children with high-risk medical conditions, patients 6 months to 5 years of age should be vaccinated against influenza each year, patients 5 to 18 years of age without high-risk medical conditions should be vaccinated against influenza each year, and previously unvaccinated patients less than 9 years of age receive 2 doses of vaccine.

Outcome measures

Outcome measures
Measure	Participants 6 to 23 Months n=118 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age	Participants 24 to 59 Months n=118 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age	Participants 5 to 8 Years n=118 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age	Participants 9 to 18 Years n=118 Participants Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage	117 Sites	118 Sites	118 Sites	117 Sites

Adverse Events

Children 6 to 23 Months

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children 24 to 59 Months

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children 5 to 8 Years

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children 9 to 18 Years

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

Chris Ambrose

MedImmune LLC

Phone: 301-398-0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Publication restrictions are in place

Restriction type: OTHER