Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

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

Completed

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Key information

Conditions

Haemophilus Infections Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Corynebacterium Infections Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Pertussis Picornaviridae Infections Polio Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

Up to 59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Albany, California, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DTaP-IPV/Hib

Biological

0.5 mL, Intramuscular

Other names: Pentacel®, ActHIB™, Comvax™, PedvaxHIB™

Primary outcomes

The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program.

Time frame: Up to 6 years post vaccination

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Mar 4, 2009
Registry last updated: Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed