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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.
 
ClinicalTrials.gov Identifier: NCT00855855
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date March 3, 2009
First Posted Date March 4, 2009
Last Update Posted Date July 28, 2020
Actual Study Start Date February 2009
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2016)
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 ]
Original Primary Outcome Measures
 (submitted: March 3, 2009)
The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. [ Time Frame: Entire study period ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
Official Title Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines
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.
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 5.2 million person years over the 6 year study period
Condition
  • Haemophilus Infections
  • Diphtheria
  • Tetanus
  • Polio
  • Pertussis
Intervention Biological: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Names:
  • Pentacel®
  • ActHIB™
  • Comvax™
  • PedvaxHIB™
Study Groups/Cohorts Hib vaccine
Participants has received at least one dose of an Hib vaccine
Intervention: Biological: DTaP-IPV/Hib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2020)
20830
Original Estimated Enrollment
 (submitted: March 3, 2009)
5000200
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages up to 59 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00855855
Other Study ID Numbers M5A15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor Sanofi Pasteur, a Sanofi Company
Collaborators Not Provided
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date July 2020