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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00683410
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : November 16, 2010
Last Update Posted : November 16, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
To collect post-marketing information on the safety of Prevenar in Filipino patients

Condition or disease Intervention/treatment
Vaccines, Pneumococcal Conjugate Vaccine Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

Study Design

Study Type : Observational
Actual Enrollment : 3366 participants
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
Study Start Date : April 2007
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1 Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Spontaneous Adverse Events [ Time Frame: 30 days post injection up to 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00683410     History of Changes
Other Study ID Numbers: 0887X-102339
First Posted: May 23, 2008    Key Record Dates
Results First Posted: November 16, 2010
Last Update Posted: November 16, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs