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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

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NCT00761631

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Benton, Arkansas, 72019 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-17 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects >15months to study period and reachable by phone, parents/legal guardian able and willing to
complete all study procedures, written documentation from health professional showing
prior vaccination with Prevnar (except for group 4).

Group 4 only:

- Negative urine pregnancy test for female subjects who are menstruating.

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 , bleeding diathesis, received blood transfusion or blood related products,
immune deficiency,congenital malformation.

Group 4 only:

- Previous vaccination with Prevnar or any other pneumococcal vaccine.

- Pregnant or breastfeeding adolescent females.

NCT00761631
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
A Phase 3, Open Label Trial Evaluating the Safety,Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States
This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Healthy Subjects
Biological: 13 valent pneumococcal conjugate vaccine
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Experimental: Single
Open label
Intervention: Biological: 13 valent pneumococcal conjugate vaccine


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects >15months to <18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

  • Negative urine pregnancy test for female subjects who are menstruating.

Exclusion Criteria:

  • Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.

Group 4 only:

  • Previous vaccination with Prevnar or any other pneumococcal vaccine.
  • Pregnant or breastfeeding adolescent females.
Sexes Eligible for Study: All
15 Months to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00761631
6096A1-3011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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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[email protected]



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