Trials / Completed
CompletedNCT02141204
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
Immunogenicity and Safety Study of Two Different Formulations of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, Rotarix in Healthy Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 451 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 10 Weeks
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose one, with no previous history of rotavirus illness or vaccination. While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008, this study is conducted to generate additional clinical data for the liquid formulation of the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines (NDAC-Vaccines) of Drug Controller General of India (DCGI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HRV Liquid | Two doses administered orally according to a 0, 1-month schedule. |
| BIOLOGICAL | HRV Lyophilized | Two doses administered orally according to a 0, 1-month schedule. |
Timeline
- Start date
- 2019-02-20
- Primary completion
- 2019-12-28
- Completion
- 2019-12-28
- First posted
- 2014-05-19
- Last updated
- 2020-12-09
- Results posted
- 2020-12-09
Locations
8 sites across 1 country: India
Source: ClinicalTrials.gov record NCT02141204. Inclusion in this directory is not an endorsement.