Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00855855

Enrollment

20830

Registered

2009-03-04

Start date

2009-02-28

Completion date

2014-12-31

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilus Infections, Diphtheria, Tetanus, Polio, Pertussis

Keywords

Diphtheria, Tetanus, Pertussis, Poliovirus types 1-3, Haemophilus influenzae type b, Pentacel®

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).

Interventions

BIOLOGICALDTaP-IPV/Hib

0.5 mL, Intramuscular

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

No minimum to 59 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026