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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Eskilstuna, , SE-63188 Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
140-392 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy children previously immunized with 1 or 2 doses of Prevenar.

- Group 1: Male or female subjects between the age of >=140 and time of enrollment.

- Group 2: Male or female subjects between the age of >=336 and time of enrollment

- Available for entire study period.

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

- Previous reaction or contra-indication to pneumococcal vaccine or vaccine related
component.

- Previous vaccination with licensed or investigational pneumococcal vaccine other than
Prevenar.

NCT00824655
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children
A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Vaccines
  • Biological: 13vPnC
    13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
  • Biological: 13vPnC
    13vPnC will be administered by intramuscular injection at approximately 12 months of age.
  • Experimental: Group 1
    Intervention: Biological: 13vPnC
  • Experimental: Group 2
    Intervention: Biological: 13vPnC
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy children previously immunized with 1 or 2 doses of Prevenar.
  • Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment.
  • Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment
  • Available for entire study period.

Exclusion Criteria:

  • Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
  • Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
Sexes Eligible for Study: All
140 Days to 392 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00824655
6096A1-3012
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Wyeth, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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.

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1-800-718-1021

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Contact

[email protected]



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