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Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00855855
First received: March 3, 2009
Last updated: May 16, 2017
Last verified: May 2017
  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:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

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 ]

Estimated Enrollment: 520000
Study Start Date: February 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00855855     History of Changes
Other Study ID Numbers: M5A15
Study First Received: March 3, 2009
Last Updated: May 16, 2017

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

ClinicalTrials.gov processed this record on June 27, 2017