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NCT00743652 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
A Phase 3 study of Pneumococcal Disease and 13-valent Pneumococcal Vaccine, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 373
- Enrollment target
- 20
- Study locations
NCT00743652: Completed Phase 3 study of Pneumococcal Disease and 13-valent Pneumococcal Vaccine, sponsored by Pfizer.
NCT00743652 is a Phase 3 study of Pneumococcal Disease and 13-valent Pneumococcal Vaccine that has completed, run by Pfizer. The registered enrollment target is 373 participants, below the 463-participant average among 3 other Pneumococcal Disease trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00743652, a Phase 3 study of Pneumococcal Disease and 13-valent Pneumococcal Vaccine, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 373 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
Primary Outcome
Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving 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) are presented. Exact 2-sided CI based upon the observed proportion of participants.
Conditions Studied
Interventions
- BIOLOGICAL 13-valent Pneumococcal Conjugate Vaccine
Study Locations (20)
Alaska
- Pfizer Investigational Site - Akiak
- Pfizer Investigational Site - Bethel
- Pfizer Investigational Site - Chefornak
- Pfizer Investigational Site - Chevak
- Pfizer Investigational Site - Eek
- Pfizer Investigational Site - Emmonak
- Pfizer Investigational Site - Hooper Bay
- Pfizer Investigational Site - Kalskag
- Pfizer Investigational Site - Kasigluk
- Pfizer Investigational Site - Kongiganak
- Pfizer Investigational Site - Kotlik
- Pfizer Investigational Site - Kwethluk
- Pfizer Investigational Site - Kwigillingok
- Pfizer Investigational Site - Mountain Village
- Pfizer Investigational Site - Napaskiak
- Pfizer Investigational Site - Newtok
- Pfizer Investigational Site - Nunapitchuk
- Pfizer Investigational Site - Russian Mission
- Pfizer Investigational Site - Scammon Bay
- Pfizer Investigational Site - Toksook Bay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00743652 record still lists
NCT00743652 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, below the 463-participant average among 3 other Pneumococcal Disease trials with a reported enrollment target (19% lower).
The record links to 2 conditions, with Pneumococcal Disease appearing as the primary indexed condition, and to 1 intervention - of which 13-valent Pneumococcal Conjugate Vaccine is the first listed.
NCT00743652 names 20 study sites across 1 states, led by Alaska.
Frequently Asked Questions
What is clinical trial NCT00743652 about?
NCT00743652 is a clinical study titled "Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.". This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
What is the current status of trial NCT00743652?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 373 participants. The study started on 2009-01. Estimated completion is 2010-09.
What conditions does trial NCT00743652 study?
This clinical trial studies the following conditions: Pneumococcal Disease, 13-valent Pneumococcal Vaccine.
What interventions are being tested in trial NCT00743652?
The interventions under investigation include: 13-valent Pneumococcal Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00743652?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00743652 being conducted?
This trial has 20 study locations across Alaska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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