NCT01171963

Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants

Efficacy, Immunogenicity 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 3
• Study type: Interventional
• Enrollment: 3,340 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 16 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.

Detailed description

Subjects can receive routine childhood vaccination according to the expanded program of immunisation recommendations in China. There will be two treatment groups (liquid human rotavirus vaccine and placebo). The study will also have two immunogenicity subgroups comprising of few subjects from both the treatment groups. The immunogenicity subgroup 1 will assess the immunogenicity of the liquid human rotavirus vaccine and the immunogenicity subgroup 2 will assess the immunogenicity of liquid human rotavirus vaccine and also the immunogenicity of oral poliovirus vaccine and diphtheria tetanus and acellular pertussis vaccine given concomitantly with liquid human rotavirus vaccine or placebo. This protocol posting has been updated following the Protocol Amendment 2, dated 05 August 2011. The impacted section in the protocol posting is: Outcome Measures Section.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' liquid human rotavirus vaccine 444563	Oral administration
BIOLOGICAL	Placebo	Oral administration
BIOLOGICAL	Infanrix™	Intramuscular administration
BIOLOGICAL	Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)	Oral administration

Timeline

• Start date: 2010-08-29
• Primary completion: 2012-05-12
• Completion: 2012-05-12
• First posted: 2010-07-29
• Last updated: 2018-08-06
• Results posted: 2013-06-24

Locations

4 sites across 1 country: China