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Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00683410
First received: May 21, 2008
Last updated: October 15, 2010
Last verified: October 2010
History of Changes
  Purpose

To collect post-marketing information on the safety of Prevenar in Filipino patients


Condition Intervention
Vaccines, Pneumococcal Conjugate Vaccine
 Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) 0.5 mL by Intramuscular Injection

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Participants With Spontaneous Adverse Events [ Time Frame: 30 days post injection up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 3366
Study Start Date: April 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary Care

Criteria

Inclusion Criteria:

  • All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.

Exclusion Criteria:

  • Previously discontinued Prevenar therapy due to safety concerns.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683410

Locations
Philippines
Muntinlupa City, Philippines
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: NCT00683410     History of Changes
Other Study ID Numbers: 0887X-102339
Study First Received: May 21, 2008
Results First Received: October 15, 2010
Last Updated: October 15, 2010
Health Authority: Philippines: Bureau of Food and Drugs

ClinicalTrials.gov processed this record on May 22, 2013