Trial record 17 of 20 for:    Open Studies | "Poliomyelitis"

Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00855855
First received: March 3, 2009
Last updated: July 23, 2014
Last verified: July 2014
  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:

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: June 2015 (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
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

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

  Show 59 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( 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: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Poliovirus types 1-3
Haemophilus influenzae type b
Pentacel®

Additional relevant MeSH terms:
Poliomyelitis
Diphtheria
Haemophilus Infections
Whooping Cough
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 August 20, 2014