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Study Investigating Administration of Prevenar for Post-Marketing Surveillance

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NCT00195390

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Seoul, , 100-380 Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-9 weeks
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to
contraindications, warnings, precautions, and interactions stated in the package
insert do not apply.

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

- Hypersensitivity to latex or to any component of the vaccine, including diphtheria
toxoid

- Suffering from a current or recent febrile illness.

NCT00195390
Pfizer
Completed
Study Investigating Administration of Prevenar for Post-Marketing Surveillance

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Study Investigating Administration of Prevenar for Post-Marketing Surveillance
Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance

The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.

  1. Adverse reactions (especially serious adverse reactions)
  2. Incidences of adverse reactions under routine vaccine use
  3. Factors that may affect the safety of the vaccine
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Primary care clinic, secondary and tertiary medical centers
Pneumococcal Infections
Biological: Prevenar
Prevenar 0.5ml/ Vial and PFS
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
July 2008
Not Provided

Inclusion Criteria:

  • Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.

Exclusion Criteria:

  • Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
  • Suffering from a current or recent febrile illness.
Sexes Eligible for Study: All
6 Weeks to 9 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00195390
0887X-101583
Not Provided
Not Provided
Not Provided
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
September 2008

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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