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OpenTrials
Completed

NCT Number: NCT00804284

Database Surveillance Safety Study of PENTACEL® Vaccine

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.

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Infections Pasteurellaceae Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

6 week–24 month

Sex eligibility

Male

Study type

Observational

Primary location

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

DTaP-IPV/Hib

Biological

0.5 mL, Intramuscular

Other names: PENTACEL®

Other DTap Vaccines

Biological

0.5 mL, Intramuscular

Other names: DAPTACEL®, INFANRIX®, PEDIARIX®, TRIPEDIA®

Primary outcomes

  1. A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Dec 8, 2008
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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