Database Surveillance Safety Study of PENTACEL® Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae

Intervention / Treatment
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* Biological: DTaP-IPV/Hib
* Biological: Other DTap Vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receipt of DTaP vaccine during the study period by a previously unvaccinated child Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 24 Months

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pentacel Group<br>Infants initiated on PENTACEL® vaccine | Biological: DTaP-IPV/Hib<br>* 0.5 mL, Intramuscular<br>* Other names: PENTACEL®;|
| Other DTap vaccines Group<br>Infants initiated on other DTaP vaccines | Biological: Other DTap Vaccines<br>* 0.5 mL, Intramuscular<br>* Other names: TRIPEDIA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review. | 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). | Up to 6 months post -dose 4 DTap Vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAPTACEL®, PENTACEL®, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b