To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
Summary
To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Conditions
Gastroenteritis
Intervention
Human rotavirus liquid vaccine
Location
GSK Investigational Site
Hanoi
Vietnam
084
Status
Completed
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00345956
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Rotavirus
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.
Rubella Vaccine
A live attenuated virus vaccine of duck embryo or human diploid cell tissue culture origin, used for routine immunization of children and for immunization of nonpregnant adolescent and adult females of childbearing age who are unimmunized and do not have serum antibodies to rubella. Children are usually immunized with measles-mumps-rubella combination vaccine. (Dorland, 28th ed)
Gastroenteritis, Transmissible, Of Swine
A condition of chronic gastroenteritis in adult pigs and fatal gastroenteritis in piglets caused by a CORONAVIRUS.
Herpes Zoster Vaccine
An attenuated vaccine used to prevent and/or treat HERPES ZOSTER, a disease caused by HUMAN HERPESVIRUS 3.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Clinical Trials
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a freq...
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a freq...
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent...
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of...
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
PubMed Articles
Rotavirus is the leading cause of severe diarrhea in children worldwide. We systematically reviewed the burden of rotavirus gastroenteritis (RVGE) and distribution of rotavirus strains in Asia.
Rotavirus gastroenteritis is the leading cause of severe acute gastroenteritis in children worldwide and is associated with high hospitalization and mortality rates in children younger than 5 years o...
This article provides an overview of the clinical profile of rotavirus vaccine RIX4414 (Rotarix™) in the prevention of rotavirus gastroenteritis (RVGE) in developing countries, followed by a review...
Rotavirus infection is the single most common cause of acute gastroenteritis in children under five years of age. The costs of care and treatment for rotavirus gastroenteritis are high. The objective...
We conducted a retrospective review of all U.S. military dependents less than 5 years old hospitalized with rotavirus-associated gastroenteritis from July 2003 to June 2009. The two post-vaccine seaso...
