Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
Public ClinicalTrials.gov record NCT01545375. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01545375
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,806 participants
Conditions and interventions
Conditions
Interventions
- Pneumococcal vaccine GSK2189242A Biological
- Placebo Biological
- Prevnar 13® Biological
- PedvaxHIB® Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Weeks to 12 Weeks
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 20, 2012
- Primary completion
- Jul 25, 2016
- Completion
- Jul 25, 2016
- Last update posted
- Dec 26, 2019
2012 – 2016
United States locations
- U.S. sites
- 5
- U.S. states
- 2
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Chinle | Arizona | 86505 | — |
| GSK Investigational Site | Fort Defiance | Arizona | 86504 | — |
| GSK Investigational Site | Whiteriver | Arizona | 85941 | — |
| GSK Investigational Site | Gallup | New Mexico | 87301 | — |
| GSK Investigational Site | Shiprock | New Mexico | 87420 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01545375, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 26, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01545375 live on ClinicalTrials.gov.