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NCT01545375 · ClinicalTrials.gov registry record · Phase 2
Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,806
- Enrollment target
NCT01545375: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01545375 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,806 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1258% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01545375, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,806 participants
- Enrollment target
Study Summary
The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.
Primary Outcome
Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP \[AAP, 2004\], as per the judgment of a treating physician or equivalent licensed medical professional: A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflam
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Prevnar 13®
- BIOLOGICAL PedvaxHIB®
- BIOLOGICAL Pneumococcal vaccine GSK2189242A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,806 participants |
| Start Date | 2012-05-21 |
| Est. Completion | 2016-07-26 |
| Phase | Phase 2 |
What the finished NCT01545375 record still lists
NCT01545375 is an interventional study that assigns participants to a tested intervention. Its 1,806 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1258% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01545375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01545375 about?
NCT01545375 is a clinical study titled "Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children". The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the N...
What is the current status of trial NCT01545375?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,806 participants. The study started on 2012-05-21. Estimated completion is 2016-07-26.
What interventions are being tested in trial NCT01545375?
The interventions under investigation include: Placebo (BIOLOGICAL), Prevnar 13® (BIOLOGICAL), PedvaxHIB® (BIOLOGICAL), Pneumococcal vaccine GSK2189242A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01545375?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01545375's enrollment target sits among peer trials
1,806 10th of 2000 higher than 1,991 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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