Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.

1. Adverse reactions (especially serious adverse reactions)
2. Incidences of adverse reactions under routine vaccine use
3. Factors that may affect the safety of the vaccine

Detailed Description

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Conditions

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Pneumococcal Infections

Keywords

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Vaccine heptavalent pneumococcal conjugate vaccine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Prevenar

Prevenar 0.5ml/ Vial and PFS

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.

Exclusion Criteria

* Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
* Suffering from a current or recent febrile illness.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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0887X-101583

Identifier Type: -

Identifier Source: org_study_id