An observational study in Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 2 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
The purpose of this cohort study is to determine vaccine-specific rates of pertussis disease during the period of the study, among Wisconsin residents younger than 60 months of age (the Surveillance Population), and to descriptively compare the proportion of such persons vaccinated with Pentacel® vaccine who acquire pertussis disease to the proportion of such persons vaccinated with any other Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccine who acquire pertussis disease.
Primary Objective:
To determine the rates and relative risk of pertussis disease among Surveillance Population members who have received Pentacel vaccine or another pertussis vaccine.
The study will be conducted by the University of Wisconsin School of Medicine and Public Health, in collaboration with the Wisconsin Division of Public Health (WDPH).
Epidemiological and laboratory surveillance for pertussis disease among Wisconsin residents is routinely conducted by the WDPH. During the period of the study, de-identified data regarding all incident pertussis cases will be obtained from WDPH and vaccination coverage rates, by vaccine regimen, age group, and period of time, will be obtained from ongoing marketplace surveillance conducted on behalf of the Sponsor by a national sample-survey organization. Using these data, rates of pertussis disease will be determined.
No vaccine will be administered as part of this study.
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 1,195 is above the median of 514 across 56 observational studies indexed under Whooping Cough.
Browse Whooping Cough studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 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.
Counted across the registry records on this site, refreshed daily.
Wisconsin residents younger than 60 months of age.
Exclusion Criteria :
Participants that only received Pentacel® vaccine.
Biological: Pentacel® (DTaP-IPV/Hib)
Participants that only received a single brand of pertussis vaccine other than Pentacel® vaccine.
Biological: Other Pertussis Vaccines
Participants that received more than one brand of Pertussis vaccine or one or more doses of an unknown brand.
Biological: Other Pertussis Vaccines
0.5 mL dose, Intramuscular
Also known as: Pentacel®
0.5 mL, Intramuscular
Also known as: DAPTACEL®, Tripedia®, TriHIBit®, Infanrix®, Pediarix®
Occurrence of pertussis disease, as determined by the Wisconsin Division of Public Health (WDPH)
Time frame: Up to 5 years
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