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.

Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Diphtheria

Pertussis

Haemophilus Infection

Tetanus

Polio

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.

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

Positive response is a 'Yes' to any of the following questions:

  1. Has your child been admitted to a hospital?

  2. 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?

  3. Has your child developed a medical condition that required 3 or more office or
     emergency room visits for that condition?

  4. 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?

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)

Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status