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Trial record 1 of 1 for:    NCT00683410
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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:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date May 21, 2008
First Posted Date May 23, 2008
Results First Submitted Date October 15, 2010
Results First Posted Date November 16, 2010
Last Update Posted Date November 16, 2010
Study Start Date April 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2010)
Number of Participants With Spontaneous Adverse Events [ Time Frame: 30 days post injection up to 3 years ]
Original Primary Outcome Measures
 (submitted: May 22, 2008)
Spontaneous Adverse Events will be collected until 30 days after each vaccination [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)
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
Brief Summary To collect post-marketing information on the safety of Prevenar in Filipino patients
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary Care
Condition Vaccines, Pneumococcal Conjugate Vaccine
Intervention Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)
Study Groups/Cohorts 1
Intervention: Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2010)
3366
Original Estimated Enrollment
 (submitted: May 22, 2008)
3000
Actual Study Completion Date October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00683410
Other Study ID Numbers 0887X-102339
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2010