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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 )

December 5, 2008
December 8, 2008
August 19, 2015
September 2008
August 2014   (Final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT00804284 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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.

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.

Observational
Observational Model: Cohort
Not Provided
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Non-Probability Sample
Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects
  • Diphtheria
  • Tetanus
  • Pertussis
  • Haemophilus Influenzae
  • Biological: DTaP-IPV/Hib
    0.5 mL, Intramuscular
    Other Name: PENTACEL®
  • Biological: Other DTap Vaccines
    0.5 mL, Intramuscular
    Other Names:
    • DAPTACEL®
    • INFANRIX®
    • PEDIARIX®
    • TRIPEDIA®
  • Pentacel Group
    Infants initiated on PENTACEL® vaccine
    Intervention: Biological: DTaP-IPV/Hib
  • Other DTap vaccines Group
    Infants initiated on other DTaP vaccines
    Intervention: Biological: Other DTap Vaccines
Hansen J, Timbol J, Lewis N, Pool V, Decker MD, Greenberg DP, Klein NP. Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers. Vaccine. 2016 Jul 29;34(35):4172-4179. doi: 10.1016/j.vaccine.2016.06.062. Epub 2016 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62538
10000
January 2015
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Sexes Eligible for Study: Male
6 Weeks to 24 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00804284
M5A11
No
Not Provided
Not Provided
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc
Sanofi
August 2015