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NCT00855855 Clinical Trial

Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Tetanus Clinical Trial

Official title:
Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00855855
Other study ID # M5A15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2009
Est. completion date December 2014

Study information
Verified date April 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.

Description:

The purpose of the study is to conduct surveillance for Hib disease. Prospective active population-based surveillance for invasive Hib disease, conducted by the Center for Disease Control and Prevention (CDC) Active Bacterial Core (ABCs) program within geographic regions currently representing 12% of the US population, will provide Hib case-occurrence (numerator) data. The ABCs program and the National Center for Health Statistics will provide annual estimates of the number of persons under surveillance, by age group, within the ABCs catchment area. Ongoing telephone sample surveys, conducted by M/A/R/C, a national sampling organization, will provide brand-specific vaccine exposure data by age group within the ABCs program catchment area at appropriate pre-specified intervals (denominator data).

Recruitment information / eligibility
Status Completed
Enrollment 20830
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 59 Months
Eligibility Inclusion Criteria: - Residence within the geographic scope of Active Bacterial Core surveillance (ABCs) during the period of surveillance - Aged 0 through 59 months (prior to 5th birthday) on the day of inclusion for Hib disease surveillance and 2 through 23 months (prior to 2nd birthday) for Hib vaccine brand usage survey. - 2009-2014 calendar years inclusive. - For the Hib vaccine usage survey, agreement to complete the required survey. Exclusion Criteria: Not applicable.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• DTaP-IPV/Hib
0.5 mL, Intramuscular

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. Up to 6 years post vaccination
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