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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,806 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01545375
The ClinicalTrials.gov registry entry for NCT01545375 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,806 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01545375 reports 0 study locations.
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.
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