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NCT00195390 Clinical Trial

Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Pneumococcal Infections Clinical Trial

Official title:
Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195390
Other study ID # 0887X-101583
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated September 24, 2008
Start date July 2004
Est. completion date July 2008

Study information
Verified date September 2008
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date July 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 9 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• Prevenar
Prevenar 0.5ml/ Vial and PFS

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

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