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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014