Study Investigating Administration of Prevenar for Post-Marketing Surveillance

N/ACompletedNCT00195390

Wyeth is now a wholly owned subsidiary of Pfizer600 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Pneumococcal Infections

Interventions

PrevenarBIOLOGICAL

Prevenar 0.5ml/ Vial and PFS

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Seoul, South Korea

Data from ClinicalTrials.gov

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