Infections, Rotavirus Clinical Trial
Official title:
Efficacy, Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants
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.
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.
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