Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

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ClinicalTrials.gov Identifier: NCT00855855

Recruitment Status : Active, not recruiting

First Posted : March 4, 2009

Last Update Posted : February 6, 2018

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

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

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 Design


Study Type :	Observational
Estimated Enrollment :	510000 participants
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
Actual Study Start Date :	February 2009
Estimated Primary Completion Date :	July 18, 2018
Estimated Study Completion Date :	July 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Haemophilus Infections

Genetic and Rare Diseases Information Center resources: Poliomyelitis Tetanus Diphtheria Whooping Cough Haemophilus Influenzae

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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™

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	up to 59 Months (Child)
Sexes Eligible for Study:	All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855855

Show 59 Study Locations

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators


Study Director:	Medical Director	Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:	NCT00855855 History of Changes
Other Study ID Numbers:	M5A15
First Posted:	March 4, 2009 Key Record Dates
Last Update Posted:	February 6, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available at Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):


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

Additional relevant MeSH terms:


Whooping Cough Tetanus Diphtheria Haemophilus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Respiratory Tract Infections Infection	Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Pasteurellaceae Infections Vaccines Immunologic Factors Physiological Effects of Drugs

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