Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855855
Recruitment Status : Active, not recruiting
First Posted : March 4, 2009
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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 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

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™

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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

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:

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 identifier (NCT number): NCT00855855

  Hide Study Locations
United States, California
Albany, California, United States, 94706
Martinez, California, United States, 94553
San Francisco, California, United States, 94102
United States, Colorado
Applewood, Colorado, United States, 80401
Aurora, Colorado, United States, 80011
Brighton, Colorado, United States, 80601
Castle Rock, Colorado, United States, 80108
Denver, Colorado, United States, 80012
United States, Connecticut
Hartford, Connecticut, United States, 06101
United States, Georgia
Adamsville, Georgia, United States, 30331
Auburn, Georgia, United States, 30011
Canton, Georgia, United States, 30114
Carrollton, Georgia, United States, 30112
Cartersville, Georgia, United States, 30120
Conyers, Georgia, United States, 30012
Covington, Georgia, United States, 30014
Cumming, Georgia, United States, 30040
Dallas, Georgia, United States, 30132
Decatur, Georgia, United States, 30030
Douglasville, Georgia, United States, 30134
Fayetteville, Georgia, United States, 30214
Good Hope, Georgia, United States, 30641
Griffin, Georgia, United States, 30223
Hampton, Georgia, United States, 30228
Jasper, Georgia, United States, 30143
Jonesboro, Georgia, United States, 30236
Marietta, Georgia, United States, 30090
Newnan, Georgia, United States, 30263
United States, Maryland
Annapolis, Maryland, United States, 21401
United States, Minnesota
Saint Paul, Minnesota, United States, 55101
United States, New Mexico
Santa Fe, New Mexico, United States, 87501
United States, New York
Albany, New York, United States, 12207
Amsterdam, New York, United States, 12010
Avon, New York, United States, 14414
Batavia, New York, United States, 14020
Bellona, New York, United States, 14415
Canandaigua, New York, United States, 14424
Catskill, New York, United States, 12414
Chatham, New York, United States, 12037
Geneva, New York, United States, 14456
Mechanicville, New York, United States, 12118
Medina, New York, United States, 14103
Palmyra, New York, United States, 14522
Rochester, New York, United States, 14603
Schenectady, New York, United States, 12008
Schoharie, New York, United States, 12157
Troy, New York, United States, 12180
United States, Oregon
Salem, Oregon, United States, 97301
United States, Tennessee
Ashland City, Tennessee, United States, 37015
Charlotte, Tennessee, United States, 37036
Chattanooga, Tennessee, United States, 37402
Franklin, Tennessee, United States, 37064
Gallatin, Tennessee, United States, 37066
Knoxville, Tennessee, United States, 37902
Lebanon, Tennessee, United States, 37087
Memphis, Tennessee, United States, 38103
Murfreesboro, Tennessee, United States, 37127
Nashville, Tennessee, United States, 37201
Springfield, Tennessee, United States, 37172
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company 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 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:

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Poliovirus types 1-3
Haemophilus influenzae type b

Additional relevant MeSH terms:
Whooping Cough
Haemophilus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Pasteurellaceae Infections
Immunologic Factors
Physiological Effects of Drugs