Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Completed

• Conditions: Haemophilus Infections; Pertussis; Tetanus; Polio; Diphtheria
• Interventions: Biological: DTaP-IPV/Hib

• Registration Number: NCT00855855
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-03
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20830

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hib vaccine	DTaP-IPV/Hib	Participants has received at least one dose of an Hib vaccine

Primary Outcome Measures

Name	Time	Method
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