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
Study identification
- NCT ID
- NCT03954743
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- GlaxoSmithKline
- Industry
- 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 18, 2019
- Primary completion
- Nov 29, 2020
- Completion
- Nov 29, 2020
- Last update posted
- Mar 9, 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 9, 2022 · Synced Jun 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03954743 live on ClinicalTrials.gov.