Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Public ClinicalTrials.gov record NCT03954743. 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
A Phase III, Observer-blind, Randomized, Multi-country Study to Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine, When Administered as a 2-dose Vaccination in 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 complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.
Study identification
- NCT ID
- NCT03954743
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,351 participants
Conditions and interventions
Conditions
Interventions
- PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine Biological
- Lyophilized formulation of GSK's oral live attenuated HRV vaccine 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
- Jul 19, 2019 (Actual)
- Primary completion
- Nov 30, 2020 (Actual)
- Completion
- Nov 30, 2020 (Actual)
- Last update posted
- Mar 10, 2022
2019 – 2020
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35235 | — |
| GSK Investigational Site | Colorado Springs | Colorado | 80922 | — |
| GSK Investigational Site | Louisville | Kentucky | 40291 | — |
| GSK Investigational Site | Frederick | Maryland | 21702 | — |
| GSK Investigational Site | Fall River | Massachusetts | 02721-1735 | — |
| GSK Investigational Site | Bingham Farms | Michigan | 48025 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68504 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68516 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68522 | — |
| GSK Investigational Site | East Orange | New Jersey | 07108 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45245 | — |
| GSK Investigational Site | Fairfield | Ohio | 45014 | — |
| GSK Investigational Site | Corvallis | Oregon | 97330 | — |
| GSK Investigational Site | Draper | Utah | 84020 | — |
| GSK Investigational Site | Murray | Utah | 84107 | — |
| GSK Investigational Site | Orem | Utah | 84057 | — |
| GSK Investigational Site | South Jordan | Utah | 84095 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22902 | — |
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 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03954743, 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 Mar 10, 2022 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03954743 live on ClinicalTrials.gov.