Database Surveillance Safety Study of PENTACEL® Vaccine

Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00804284

Enrollment

62538

Registered

2008-12-08

Start date

2008-09-30

Completion date

2015-01-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae

Keywords

DAPTACEL®, PENTACEL®, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALDTaP-IPV/Hib

0.5 mL, Intramuscular

BIOLOGICALOther DTap Vaccines

0.5 mL, Intramuscular

Study design

Observational model

COHORT

Eligibility

Sex/Gender

MALE

Age

6 Weeks to 24 Months

Healthy volunteers

Yes

Inclusion criteria

* Receipt of DTaP vaccine during the study period by a previously unvaccinated child

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.	Up to 6 months post -dose 4 DTap Vaccination	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026