Status:
COMPLETED
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
Lead Sponsor:
Pfizer
Conditions:
Healthy Subjects
Eligibility:
All Genders
15-17 years
Phase:
PHASE3
Brief Summary
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 le...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00761631
Start Date
December 1 2008
End Date
July 1 2010
Last Update
July 31 2013
Active Locations (31)
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1
Pfizer Investigational Site
Benton, Arkansas, United States, 72019
2
Pfizer Investigational Site
Fayetteville, Arkansas, United States, 72703
3
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
4
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205