An observational study in Diphtheria, Tetanus and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in United States. Open to male participants aged 6 Weeks to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-19.
Sponsored by Sanofi Pasteur, a Sanofi Company · Observational
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.
Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 62,538 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.
Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects
Exclusion Criteria:
Infants initiated on PENTACEL® vaccine
Biological: DTaP-IPV/Hib
Infants initiated on other DTaP vaccines
Biological: Other DTap Vaccines
0.5 mL, Intramuscular
Also known as: PENTACEL®
0.5 mL, Intramuscular
Also known as: DAPTACEL®, INFANRIX®, PEDIARIX®, TRIPEDIA®
A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as: * Death, * Outpatient clinic visit for: * seizure occurring within 72 hours of vaccination, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness (other than secondary to another diagnosis), or meningitis * hypersensitivity reactions (e.g. urticaria, angioedema, or anaphylaxis) occurring within 72 hours of vaccination, * new-onset autoimmune disease (including idiopathic thrombocytopenic purpura, hemolytic anemia).
Time frame: Up to 6 months post -dose 4 DTap Vaccination
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company