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Study Investigating Administration of Prevenar for Post-Marketing Surveillance

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ClinicalTrials.gov Identifier: NCT00195390
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:

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
Pneumococcal Infections Biological: Prevenar Phase 4

Study Design

Study Type : Observational
Estimated 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 : July 2004
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Biological: Prevenar
    Prevenar 0.5ml/ Vial and PFS

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 9 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00195390     History of Changes
Other Study ID Numbers: 0887X-101583
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008

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
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs