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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

May 21, 2008
October 15, 2010
April 2007
October 2009   (final data collection date for primary outcome measure)
Number of Participants With Spontaneous Adverse Events [ Time Frame: 30 days post injection up to 3 years ] [ Designated as safety issue: Yes ]
Spontaneous Adverse Events will be collected until 30 days after each vaccination [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00683410 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)
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

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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary Care

Vaccines, Pneumococcal Conjugate Vaccine
Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)
1
Intervention: Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3366
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00683410
0887X-102339
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP