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Rotavirus Gastroenteritis clinical trials

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NCT ID: NCT01575197 Completed - Clinical trials for Rotavirus Gastroenteritis

Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.

NCT ID: NCT01508533 Completed - Clinical trials for Rotavirus Gastroenteritis

Epidemiology of Rotavirus Infection in North India Community

Start date: July 2009
Phase: N/A
Study type: Observational

This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.

NCT ID: NCT01265355 Completed - Clinical trials for Rotavirus Gastroenteritis

Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement

Start date: March 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The investigators hypothesize that use of a food based prophylactic will decrease incidence of rotavirus infection in young children in south India, prevent intestinal damage and overall result in lower infection rates and better gut function. This trial will evaluate the efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or antibody fragments expressed in yeast or placebo are given daily as a food supplement to children between the ages of 6 and 12 months. The children will followed for one year and rates of rotavirus diarrhoea, antibody responses and gut function will be compared between children receiving antibody fragments or placebo.

NCT ID: NCT01236066 Completed - Gastroenteritis Clinical Trials

Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia

Start date: October 2010
Phase: N/A
Study type: Observational

This study aims to monitor the incidence rates and duration of hospitalisations for rotavirus gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to 2009, in children < 5 years of age after the introduction of Rotarix in 2006 by year, both inside and outside rotavirus season in Australia. It further aims to compare the two dose regimen of Rotarix with the three dose regimen of RotaTeq from 2007 to 2009.

NCT ID: NCT01202201 Completed - Clinical trials for Rotavirus Gastroenteritis

A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan

Start date: September 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the epidemiology and baseline disease burden of rotavirus gastroenteritis in children < 6 years of age, in Japan.

NCT ID: NCT01199874 Completed - Clinical trials for Rotavirus Gastroenteritis

Immunogenicity of Rotavirus Vaccine

Start date: April 2011
Phase: Phase 4
Study type: Interventional

Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives: 1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life. 2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.

NCT ID: NCT01177657 Completed - Clinical trials for Rotavirus Gastroenteritis

Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil

Start date: May 2008
Phase: N/A
Study type: Observational

The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.

NCT ID: NCT01091298 Completed - Clinical trials for Rotavirus Gastroenteritis

A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers

Start date: April 2010
Phase: Phase 1
Study type: Interventional

This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 mL of vaccine.

NCT ID: NCT01026779 Completed - Clinical trials for Rotavirus Gastroenteritis

Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island

Start date: July 2009
Phase:
Study type: Observational

The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. The investigators will use cases of rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the 2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island. Finally using the state child health database, KIDSNET the investigators plan to investigate the reasons that children may not have received rotavirus vaccine in order to better target educational efforts for parents and health care providers.

NCT ID: NCT00953056 Completed - Clinical trials for Rotavirus Gastroenteritis

A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)

Start date: September 2009
Phase: Phase 1
Study type: Interventional

This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.