Study Investigating Administration of Prevenar for Post-Marketing Surveillance - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195390

Purpose

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.

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

Condition	Intervention	Phase
Pneumococcal Infections	Biological: Prevenar	Phase IV

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	July 2004
Study Completion Date:	July 2008

Intervention Details:

Prevenar 0.5ml/ Vial and PFS

Eligibility

Ages Eligible for Study:	6 Weeks to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic, secondary and tertiary medical centers

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195390

Locations

Korea, Republic of

Seoul, Korea, Republic of, 100-380

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0887X-101583
Study First Received:	September 12, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00195390
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Wyeth:

Vaccine
heptavalent pneumococcal conjugate vaccine

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Pneumococcal Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009