Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00855855

Purpose

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

Condition	Intervention
Haemophilus Infections Diphtheria Tetanus Polio Pertussis	Biological: DTaP-IPV/Hib

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. [ Time Frame: Entire study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	520000
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Hib vaccine Participants has received at least one dose of an Hib vaccine	Biological: DTaP-IPV/Hib 0.5 mL, Intramuscular Other Names: Pentacel® ActHIB™ Comvax™ PedvaxHIB™

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).

Eligibility

Ages Eligible for Study:	up to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

5.2 million person years over the 6 year study period

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855855

Contacts

Contact: Public Registry Sanofi Pasteur

RegistryContactUs@sanofipasteur.com

Show 59 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00855855 History of Changes
Other Study ID Numbers:	M5A15
Study First Received:	March 3, 2009
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Diphtheria
Tetanus
Pertussis

Poliovirus types 1-3
Haemophilus influenzae type b
Pentacel®

Additional relevant MeSH terms:

Diphtheria
Haemophilus Infections
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bordetella Infections
Respiratory Tract Infections
Infection

Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on February 09, 2012