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Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

NCT ID: NCT00683410

Last Updated: 2010-11-16

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

3366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-10-31

Brief Summary

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To collect post-marketing information on the safety of Prevenar in Filipino patients

Detailed Description

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Conditions

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Vaccines, Pneumococcal Conjugate Vaccine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

Intervention Type BIOLOGICAL

Interventions

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Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.

Exclusion Criteria

* Previously discontinued Prevenar therapy due to safety concerns.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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City of Muntinlupa, , Philippines

Site Status

Countries

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United States Philippines

Other Identifiers

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0887X-102339

Identifier Type: -

Identifier Source: org_study_id