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ROTATEQ Reexamination Study

2014-08-27 03:15:42 | BioPortfolio

Summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.

Study Design

Time Perspective: Prospective

Conditions

Gastroenteritis Rotavirus

Location

MSD Korea Ltd.
Seoul
Korea, Republic of
121-705

Status

Recruiting

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

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Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

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...

Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

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...

Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

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...

Optimising Rotavirus Vaccine in Aboriginal Children

Australian Indigenous children, particularly those living in remote communities, suffer a disproportionately high burden of rotavirus gastroenteritis disease. Despite the introduction of r...

A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia

This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.

PubMed Articles [195 Associated PubMed Articles listed on BioPortfolio]

Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis among Vaccinated Infants in Low- and Middle-Income Countries.

Altering rotavirus vaccine schedules may improve vaccine performance in low- and middle-income countries. We analyzed data from clinical trials of the monovalent (RV1) and pentavalent (RV5) rotavirus ...

Molecular characterisation of rotavirus strains detected during a clinical trial of the human neonatal rotavirus vaccine (RV3-BB) in Indonesia.

The RV3-BB human neonatal rotavirus vaccine aims to provide protection from severe rotavirus disease from birth. The aim of the current study was to characterise the rotavirus strains causing gastroen...

Acute Gastroenteritis in a Pediatric Population from Cali, Colombia in the Post-Rotavirus Vaccine Era.

In Latin America, there is little epidemiological data resulting from highly sensitive molecular techniques for the study of acute gastroenteritis (AGE) in the post-rotavirus vaccine era.

Post-Licensure experience with rotavirus vaccination in Latin America and the Caribbean: a systematic review and meta-analysis.

Latin American countries were among the first to adopt rotavirus vaccines into national immunization programs; we reviewed one decade of their experience with rotavirus vaccination. Areas covered: We ...

Molecular and biological characterization of the human-bovine rotavirus-based reassortant rotavirus.

Rotaviruses (RV) are the leading cause of acute infantile gastroenteritis, associated with elevated mortality in low-income countries. Morbidity and mortality, length and rates of hospitalization due ...

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.

Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE).

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