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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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