This trial is active, not recruiting.

Conditions haemophilus infections, diphtheria, tetanus, polio, pertussis
Treatment dtap-ipv/hib
Sponsor Sanofi Pasteur, a Sanofi Company
Start date February 2009
End date June 2015
Trial size 520000 participants
Trial identifier NCT00855855, M5A15


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Participants has received at least one dose of an Hib vaccine
dtap-ipv/hib Pentacel®
0.5 mL, Intramuscular

Primary Outcomes

The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program.
time frame: Entire study period

Eligibility Criteria

Male or female participants up to 59 months old.

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.

Additional Information

Official title Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Sanofi.