Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Public ClinicalTrials.gov record NCT02914184. 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
Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.
Study identification
- NCT ID
- NCT02914184
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,612 participants
Conditions and interventions
Conditions
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
- Oct 27, 2016 (Actual)
- Primary completion
- Jun 27, 2018 (Actual)
- Completion
- Nov 26, 2018 (Actual)
- Last update posted
- Jul 21, 2020
2016 – 2018
United States locations
- U.S. sites
- 19
- U.S. states
- 10
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35235 | — |
| GSK Investigational Site | Anaheim | California | 92804 | — |
| GSK Investigational Site | Paramount | California | 90723 | — |
| GSK Investigational Site | Sacramento | California | 95815 | — |
| GSK Investigational Site | San Jose | California | 95119 | — |
| GSK Investigational Site | Nampa | Idaho | 83686 | — |
| GSK Investigational Site | Newton | Kansas | 67114 | — |
| GSK Investigational Site | Topeka | Kansas | 66604 | — |
| GSK Investigational Site | Kansas City | Missouri | 64108 | — |
| GSK Investigational Site | Cleveland | Ohio | 44121 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16506 | — |
| GSK Investigational Site | Cheraw | South Carolina | 29520 | — |
| GSK Investigational Site | North Charleston | South Carolina | 29456-9170 | — |
| GSK Investigational Site | Layton | Utah | 84041 | — |
| GSK Investigational Site | Murray | Utah | 84107 | — |
| GSK Investigational Site | Orem | Utah | 84057 | — |
| GSK Investigational Site | Provo | Utah | 84604 | — |
| GSK Investigational Site | Syracuse | Utah | 84075 | — |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02914184, 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 Jul 21, 2020 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02914184 live on ClinicalTrials.gov.