An observational study in Haemophilus Infections, Diphtheria and Tetanus, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 59 sites in United States. Open to participants aged Up to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi Pasteur, a Sanofi Company · Observational
To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.
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).
5.2 million person years over the 6 year study period
Exclusion Criteria:
Not applicable.
Participants has received at least one dose of an Hib vaccine
Biological: DTaP-IPV/Hib
0.5 mL, Intramuscular
Also known as: Pentacel®, ActHIB™, Comvax™, PedvaxHIB™
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
Plan to share: Yes — 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 study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company