NCT00855855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

59 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

5.8 years

First QC Date

March 3, 2009

Last Update Submit

April 21, 2022

Conditions

Haemophilus InfectionsDiphtheriaTetanusPolioPertussis

Keywords

DiphtheriaTetanusPertussisPoliovirus types 1-3Haemophilus influenzae type bPentacel®

Outcome Measures

Primary Outcomes (1)

  • The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program.

    Up to 6 years post vaccination

Study Arms (1)

Hib vaccine

Participants has received at least one dose of an Hib vaccine

Biological: DTaP-IPV/Hib

Interventions

DTaP-IPV/HibBIOLOGICAL

0.5 mL, Intramuscular

Also known as: Pentacel®, ActHIB™, Comvax™, PedvaxHIB™
Hib vaccine

Eligibility Criteria

AgeUp to 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

5.2 million person years over the 6 year study period

You may qualify if:

  • Residence within the geographic scope of Active Bacterial Core surveillance (ABCs) during the period of surveillance
  • calendar years inclusive.
  • For the Hib vaccine usage survey, agreement to complete the required survey.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (59)

Unknown Facility

Albany, California, 94706, United States

Location

Unknown Facility

Martinez, California, 94553, United States

Location

Unknown Facility

San Francisco, California, 94102, United States

Location

Unknown Facility

Applewood, Colorado, 80401, United States

Location

Unknown Facility

Aurora, Colorado, 80011, United States

Location

Unknown Facility

Brighton, Colorado, 80601, United States

Location

Unknown Facility

Castle Rock, Colorado, 80108, United States

Location

Unknown Facility

Denver, Colorado, 80012, United States

Location

Unknown Facility

Hartford, Connecticut, 06101, United States

Location

Unknown Facility

Adamsville, Georgia, 30331, United States

Location

Unknown Facility

Auburn, Georgia, 30011, United States

Location

Unknown Facility

Canton, Georgia, 30114, United States

Location

Unknown Facility

Carrollton, Georgia, 30112, United States

Location

Unknown Facility

Cartersville, Georgia, 30120, United States

Location

Unknown Facility

Conyers, Georgia, 30012, United States

Location

Unknown Facility

Covington, Georgia, 30014, United States

Location

Unknown Facility

Cumming, Georgia, 30040, United States

Location

Unknown Facility

Dallas, Georgia, 30132, United States

Location

Unknown Facility

Decatur, Georgia, 30030, United States

Location

Unknown Facility

Douglasville, Georgia, 30134, United States

Location

Unknown Facility

Fayetteville, Georgia, 30214, United States

Location

Unknown Facility

Good Hope, Georgia, 30641, United States

Location

Unknown Facility

Griffin, Georgia, 30223, United States

Location

Unknown Facility

Hampton, Georgia, 30228, United States

Location

Unknown Facility

Jasper, Georgia, 30143, United States

Location

Unknown Facility

Jonesboro, Georgia, 30236, United States

Location

Unknown Facility

Marietta, Georgia, 30090, United States

Location

Unknown Facility

Newnan, Georgia, 30263, United States

Location

Unknown Facility

Annapolis, Maryland, 21401, United States

Location

Unknown Facility

Saint Paul, Minnesota, 55101, United States

Location

Unknown Facility

Santa Fe, New Mexico, 87501, United States

Location

Unknown Facility

Albany, New York, 12207, United States

Location

Unknown Facility

Amsterdam, New York, 12010, United States

Location

Unknown Facility

Avon, New York, 14414, United States

Location

Unknown Facility

Batavia, New York, 14020, United States

Location

Unknown Facility

Bellona, New York, 14415, United States

Location

Unknown Facility

Canandaigua, New York, 14424, United States

Location

Unknown Facility

Catskill, New York, 12414, United States

Location

Unknown Facility

Chatham, New York, 12037, United States

Location

Unknown Facility

Geneva, New York, 14456, United States

Location

Unknown Facility

Mechanicville, New York, 12118, United States

Location

Unknown Facility

Medina, New York, 14103, United States

Location

Unknown Facility

Palmyra, New York, 14522, United States

Location

Unknown Facility

Rochester, New York, 14603, United States

Location

Unknown Facility

Schenectady, New York, 12008, United States

Location

Unknown Facility

Schoharie, New York, 12157, United States

Location

Unknown Facility

Troy, New York, 12180, United States

Location

Unknown Facility

Salem, Oregon, 97301, United States

Location

Unknown Facility

Ashland City, Tennessee, 37015, United States

Location

Unknown Facility

Charlotte, Tennessee, 37036, United States

Location

Unknown Facility

Chattanooga, Tennessee, 37402, United States

Location

Unknown Facility

Franklin, Tennessee, 37064, United States

Location

Unknown Facility

Gallatin, Tennessee, 37066, United States

Location

Unknown Facility

Knoxville, Tennessee, 37902, United States

Location

Unknown Facility

Lebanon, Tennessee, 37087, United States

Location

Unknown Facility

Memphis, Tennessee, 38103, United States

Location

Unknown Facility

Murfreesboro, Tennessee, 37127, United States

Location

Unknown Facility

Nashville, Tennessee, 37201, United States

Location

Unknown Facility

Springfield, Tennessee, 37172, United States

Location

Related Links

MeSH Terms

Conditions

Haemophilus InfectionsDiphtheriaTetanusPoliomyelitisWhooping Cough

Interventions

diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccinepentacelHaemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugateCOMVAXHaemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine

Condition Hierarchy (Ancestors)

Pasteurellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsCorynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsClostridium InfectionsMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesBordetella InfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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

Locations

US(59)