Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Study Overview
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Brief Summary
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The purpose of this survey is to collect selected safety data. Primary Objective: To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.

Detailed Description
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This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.

Official Title
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Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children

Conditions
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Diphtheria, Pertussis, Haemophilus Infection, Tetanus, Polio

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday. Written Informed Consent and Telephone consent from the parent(s) or guardian(s). Able to comply with the survey procedures. Exclusion Criteria: Fourth dose of the Pentacel® series received on or after the child's 2nd birthday.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series | Positive response is a 'Yes' to any of the following questions: Has your child been admitted to a hospital? Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office? Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition? Has your child been diagnosed by a physician as having: Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism? | 6 months post 4th dose vaccination | 
| Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. | SAE: any untoward medical occurrence with the following outcomes: death, a life-threatening adverse drug experience (as confirmed by the investigators), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0) | 6 Months post 4th dose vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis, Whooping cough, Diphtheria, Tetanus, Haemophilus influenzae, Poliovirus Types 1, 2, and 3.