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Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants

Rotavirus Clinical Trial

Official title:
Immunogenicity and Safety Study of Two Different Formulations of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, Rotarix in Healthy Infants

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02141204
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date February 20, 2019
Completion date December 28, 2019
View Details
See also
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