Database Surveillance Safety Study of PENTACEL® Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00804284 |
Recruitment Status :
Completed
First Posted : December 8, 2008
Last Update Posted : August 19, 2015
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Condition or disease | Intervention/treatment |
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Diphtheria Tetanus Pertussis Haemophilus Influenzae | Biological: DTaP-IPV/Hib Biological: Other DTap Vaccines |
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 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 |

Group/Cohort | Intervention/treatment |
---|---|
Pentacel Group
Infants initiated on PENTACEL® vaccine
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Biological: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Name: PENTACEL® |
Other DTap vaccines Group
Infants initiated on other DTaP vaccines
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Biological: Other DTap Vaccines
0.5 mL, Intramuscular
Other Names:
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- 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,
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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).

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, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Weeks to 24 Months (Child) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Receipt of DTaP vaccine during the study period by a previously unvaccinated child
Exclusion Criteria:
- None

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
United States, California | |
Oakland, California, United States, 94612 |
Study Director: | Medical Director | Sanofi Pasteur Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
DAPTACEL® PENTACEL® Diphtheria |
Tetanus Pertussis Haemophilus influenzae type b |
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 |