Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

April 21, 2022 updated by: Sanofi Pasteur, a Sanofi Company

Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines

To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20830

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Albany, California, United States, 94706
      • Martinez, California, United States, 94553
      • San Francisco, California, United States, 94102
    • 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
    • Connecticut
      • Hartford, Connecticut, United States, 06101
    • 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
    • Maryland
      • Annapolis, Maryland, United States, 21401
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
    • New Mexico
      • Santa Fe, New Mexico, United States, 87501
    • 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
    • Oregon
      • Salem, Oregon, United States, 97301
    • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

5.2 million person years over the 6 year study period

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 6 years post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M5A15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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