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

Last updated on March 26, 2020

FOR MORE INFORMATION
Study Location
Muntinlupa City, , Philippines
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previously discontinued Prevenar therapy due to safety concerns.

NCT00683410
Pfizer
Completed
Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

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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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now