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Database Surveillance Safety Study of PENTACEL® Vaccine

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier:
First received: December 5, 2008
Last updated: August 17, 2015
Last verified: August 2015
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.

Condition Intervention
Diphtheria Tetanus Pertussis Haemophilus Influenzae Biological: DTaP-IPV/Hib Biological: Other DTap Vaccines

Study Type: Observational
Study Design: Observational Model: Cohort
Official 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

Resource links provided by NLM:

Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • 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).

Enrollment: 62538
Study Start Date: September 2008
Study Completion Date: January 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pentacel Group
Infants initiated on PENTACEL® vaccine
Biological: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Name: PENTACEL®
Other DTap vaccines Group
Infants initiated on other DTaP vaccines
Biological: Other DTap Vaccines
0.5 mL, Intramuscular
Other Names:

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.


Ages Eligible for Study:   6 Weeks to 24 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00804284

United States, California
Oakland, California, United States, 94612
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT00804284     History of Changes
Other Study ID Numbers: M5A11
Study First Received: December 5, 2008
Last Updated: August 17, 2015

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Haemophilus influenzae type b

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017