Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

NCT ID: NCT00772369

Last Updated: 2014-02-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-04-30

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.

Conditions

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Diphtheria Pertussis Haemophilus Infection Tetanus Polio

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

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Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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M5A08

Identifier Type: -

Identifier Source: org_study_id

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