Trials / Completed
CompletedNCT03954743
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,351 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine | 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries. |
| BIOLOGICAL | Lyophilized formulation of GSK's oral live attenuated HRV vaccine | 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries. |
Timeline
- Start date
- 2019-07-19
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
- First posted
- 2019-05-17
- Last updated
- 2022-03-10
- Results posted
- 2021-06-18
Locations
37 sites across 5 countries: United States, Canada, Hong Kong, Taiwan, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03954743. Inclusion in this directory is not an endorsement.