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Trial record 1 of 1 for:    M5A11
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Database Surveillance Safety Study of PENTACEL® Vaccine

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ClinicalTrials.gov Identifier: NCT00804284
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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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.

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

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.

Study Design
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Study Type : Observational
Actual Enrollment : 62538 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : August 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  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).


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804284


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00804284    
Other Study ID Numbers: M5A11
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
DAPTACEL®
PENTACEL®
Diphtheria
 Tetanus
Pertussis
Haemophilus influenzae type b
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Tetany
Respiratory Tract Infections
Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections