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 (part of Sanofi) · Observational
Among 26 studies in Haemophilus Infections by Sanofi Pasteur, a Sanofi Company — none open to participants now, none under way, none of them phase 3. Haemophilus Infections · Sanofi Pasteur, a Sanofi Company.
Among the 26 studies in Haemophilus Infections by Sanofi Pasteur, a Sanofi Company, this one is the only one that started in 2009, is one of 3 observational ones, and was the 22nd registered.
176 studies on the registry are indexed under Haemophilus Infections; 5 are open to participants now.
This study's enrollment of 20,830 is above the median of 511 across 10 observational studies indexed under Haemophilus Infections.
Browse Haemophilus Infections studies →None of the 26 studies in Haemophilus Infections by Sanofi Pasteur, a Sanofi Company is open now.
Of the 2 Haemophilus Infections studies recruiting now, 0 (0%) set no upper age limit and 2 (100%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: Up to 59 Months · all sexes · healthy volunteers too.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2009.
Median enrollment 624 across the 23 interventional studies, 20,830 across the 3 observational. Of the 26 that completed or were terminated, 17 (65%) have results posted.
Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 26 studies in Haemophilus Infections by Sanofi Pasteur, a Sanofi Company, from their registry updates:
Nothing recorded among them since 2026-09-25.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Not applicable.
Participants has received at least one dose of an Hib vaccine
Biological: DTaP-IPV/Hib
Drug page: Pentacel
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
Ran from Feb 2009 to primary completion in Dec 2014, 70 months.
How these figures are worked out, and which studies are left out of them.
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 →