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Study Investigating Administration of Prevenar for Post-Marketing Surveillance

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195390
First received: September 12, 2005
Last updated: September 24, 2008
Last verified: September 2008
History of Changes
  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.

  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

Condition Intervention Phase
Pneumococcal Infections
 Biological: Prevenar
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 600
Study Start Date: July 2004
Study Completion Date: July 2008
Intervention Details:
    Biological: Prevenar
    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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Vaccine
heptavalent pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013