Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Wyeth

Status: Completed

Conditions: Pneumococcal Infections

Treatments: Biological: Prevenar

Study type: Observational

Funder types: Industry

Identifiers

NCT00195390

0887X-101583

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 6 weeks to 9 years old

Volunteers: Accepts Healthy Volunteers

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.