Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
NCT ID: NCT00855855
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
20830 participants
OBSERVATIONAL
2009-02-28
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
NCT00332566
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
NCT01125527
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
NCT00255021
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
NCT01457508
Safety and Immune Response of Different Pediatric Combination Vaccines.
NCT00255047
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hib vaccine
Participants has received at least one dose of an Hib vaccine
DTaP-IPV/Hib
0.5 mL, Intramuscular
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
59 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Albany, California, United States
Martinez, California, United States
San Francisco, California, United States
Applewood, Colorado, United States
Aurora, Colorado, United States
Brighton, Colorado, United States
Castle Rock, Colorado, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Adamsville, Georgia, United States
Auburn, Georgia, United States
Canton, Georgia, United States
Carrollton, Georgia, United States
Cartersville, Georgia, United States
Conyers, Georgia, United States
Covington, Georgia, United States
Cumming, Georgia, United States
Dallas, Georgia, United States
Decatur, Georgia, United States
Douglasville, Georgia, United States
Fayetteville, Georgia, United States
Good Hope, Georgia, United States
Griffin, Georgia, United States
Hampton, Georgia, United States
Jasper, Georgia, United States
Jonesboro, Georgia, United States
Marietta, Georgia, United States
Newnan, Georgia, United States
Annapolis, Maryland, United States
Saint Paul, Minnesota, United States
Santa Fe, New Mexico, United States
Albany, New York, United States
Amsterdam, New York, United States
Avon, New York, United States
Batavia, New York, United States
Bellona, New York, United States
Canandaigua, New York, United States
Catskill, New York, United States
Chatham, New York, United States
Geneva, New York, United States
Mechanicville, New York, United States
Medina, New York, United States
Palmyra, New York, United States
Rochester, New York, United States
Schenectady, New York, United States
Schoharie, New York, United States
Troy, New York, United States
Salem, Oregon, United States
Ashland City, Tennessee, United States
Charlotte, Tennessee, United States
Chattanooga, Tennessee, United States
Franklin, Tennessee, United States
Gallatin, Tennessee, United States
Knoxville, Tennessee, United States
Lebanon, Tennessee, United States
Memphis, Tennessee, United States
Murfreesboro, Tennessee, United States
Nashville, Tennessee, United States
Springfield, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M5A15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.