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Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00195390
Collaborator
(none)
600
Enrollment
1
Location
48
Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Biological: Prevenar

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance
Study Start Date :
Jul 1, 2004
Actual Study Completion Date :
Jul 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Weeks to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00195390
    Other Study ID Numbers:
    • 0887X-101583
    First Posted:
    Sep 19, 2005
    Last Update Posted:
    Sep 25, 2008
    Last Verified:
    Sep 1, 2008
    Keywords provided by , ,
    Vaccine
    heptavalent pneumococcal conjugate vaccine
    Additional relevant MeSH terms:
    Pneumococcal Infections
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    No Results Posted as of Sep 25, 2008