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Database Surveillance Safety Study of PENTACEL® Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00804284
First received: December 5, 2008
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ] [ Designated as safety issue: No ]

    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).


Estimated Enrollment: 10000
Study Start Date: September 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 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:
  • DAPTACEL®
  • INFANRIX®
  • PEDIARIX®
  • TRIPEDIA®

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 24 Months
Genders 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804284

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

No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00804284     History of Changes
Other Study ID Numbers: M5A11
Study First Received: December 5, 2008
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
DAPTACEL®
PENTACEL®
Diphtheria
 Tetanus
Pertussis
Haemophilus influenzae type b

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Influenza, Human
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Infection
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013