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Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

2014-08-27 03:19:38 | BioPortfolio

Summary

The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination. The study also aims to compare the immunogenicity of the vaccine antigen in this study with that of the vaccine antigen in study NCT00140673.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Rotavirus Gastroenteritis

Intervention

Rotarix ™, Placebo

Location

GSK Investigational Site
Busan
Korea, Republic of
614-735

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:38-0400

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Medical and Biotech [MESH] Definitions

A genus of REOVIRIDAE, causing acute gastroenteritis in BIRDS and MAMMALS, including humans. Transmission is horizontal and by environmental contamination. Seven species (Rotaviruses A thru G) are recognized.

A condition of chronic gastroenteritis in adult pigs and fatal gastroenteritis in piglets caused by a CORONAVIRUS.

Vaccines or candidate vaccines used to prevent infection with ROTAVIRUS.

INFLAMMATION of any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM. Causes of gastroenteritis are many including genetic, infection, HYPERSENSITIVITY, drug effects, and CANCER.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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