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Trials / Completed

CompletedNCT01107587

Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants

Reactogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine 444563, in Healthy Infants

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
50 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
6 Weeks – 16 Weeks
Healthy volunteers
Accepted

Summary

The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.

Conditions

Interventions

TypeNameDescription
BIOLOGICALGSK Biologicals' human rotavirus vaccine 444563Oral, two doses.
BIOLOGICALPlaceboOral, two doses.

Timeline

Start date
2010-04-13
Primary completion
2010-06-28
Completion
2010-06-28
First posted
2010-04-21
Last updated
2017-05-19

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01107587. Inclusion in this directory is not an endorsement.

Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants (NCT01107587) · Clinical Trials Directory