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NCT00761631 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
A Phase 3 study of Healthy Subjects, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
- 20
- Study locations
NCT00761631: Completed Phase 3 study of Healthy Subjects, sponsored by Pfizer.
NCT00761631 is a Phase 3 study of Healthy Subjects that has completed, run by Pfizer. The registered enrollment target is 1,200 participants, above the 111-participant average among 69 other Healthy Subjects trials with a reported enrollment target (981% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00761631, a Phase 3 study of Healthy Subjects, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
Conditions Studied
Interventions
- BIOLOGICAL 13 valent pneumococcal conjugate vaccine
Study Locations (20)
Arkansas
- Pfizer Investigational Site - Benton
- Pfizer Investigational Site - Fayetteville
- Pfizer Investigational Site - Jonesboro
- Pfizer Investigational Site - Little Rock
California
- Pfizer Investigational Site - Fountain Valley
- Pfizer Investigational Site - Loma Linda
- Pfizer Investigational Site - Torrance
North Dakota
- Pfizer Investigational Site - Bismarck
- Pfizer Investigational Site - Fargo
Ohio
- Pfizer Investigational Site - Cincinnati
- Pfizer Investigational Site - Cleveland
Florida
- Pfizer Investigational Site - Tampa
Georgia
- Pfizer Investigational Site - Marietta
Illinois
- Pfizer Investigational Site - DeKalb
Kentucky
- Pfizer Investigational Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00761631 record still lists
NCT00761631 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 111-participant average among 69 other Healthy Subjects trials with a reported enrollment target (981% higher).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which 13 valent pneumococcal conjugate vaccine is the first listed.
NCT00761631 names 20 study sites across 13 states, led by Arkansas, California, North Dakota.
Frequently Asked Questions
What is clinical trial NCT00761631 about?
NCT00761631 is a clinical study titled "Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years". 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.
What is the current status of trial NCT00761631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2008-12. Estimated completion is 2010-07.
What conditions does trial NCT00761631 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT00761631?
The interventions under investigation include: 13 valent pneumococcal conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00761631?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00761631 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Subjects
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00761631's enrollment target sits among peer trials
1,200 2nd of 69 the highest of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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