Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
NCT00761631
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years | |||
Official Title ICMJE | 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 | |||
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 less than 18 years. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Healthy Subjects | |||
Intervention ICMJE | 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. | |||
Study Arms ICMJE | Experimental: Single
Open label Intervention: Biological: 13 valent pneumococcal conjugate vaccine | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1200 | |||
Original Estimated Enrollment ICMJE | 407 | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Group 4 only:
Exclusion Criteria:
Group 4 only:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 15 Months to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00761631 | |||
Other Study ID Numbers ICMJE | 6096A1-3011 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |