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Rotavirus Infections clinical trials

View clinical trials related to Rotavirus Infections.

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NCT ID: NCT00346892 Completed - Clinical trials for Rotavirus Infections

To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV

Start date: November 2001
Phase: Phase 2
Study type: Interventional

"The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines. The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."

NCT ID: NCT00345956 Completed - Clinical trials for Infections, Rotavirus

To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)

Start date: September 2006
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT00334607 Completed - Clinical trials for Infections, Rotavirus

Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA

Start date: June 2006
Phase: Phase 3
Study type: Interventional

The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.

NCT ID: NCT00302640 Completed - Rotavirus Infection Clinical Trials

Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Start date: February 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.

NCT ID: NCT00289172 Completed - Clinical trials for Infections, Rotavirus

Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India

Start date: February 10, 2006
Phase: Phase 3
Study type: Interventional

Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.

NCT ID: NCT00280111 Completed - Clinical trials for Rotavirus Infections

Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants

Start date: January 2005
Phase: Phase 1
Study type: Interventional

It has been observed that in children who get a severe rotavirus infection, subsequent infections cause either no symptoms or generally only mild or moderate diarrhea. This evidence is the basis for developing a vaccine since it suggests that the first infection immunizes the child against disease upon re-infection. It was found that neonatal avirulent strains 116E and I321 induce protective immunity and offer clinical protection for at least one year. Both these strains are well characterized and the safety studies have been done in animal models. These candidate vaccine strains have been evaluated for safety and immunogenicity in adults and children (2 to 12 years of age) by a randomized double blind placebo controlled trial in Cincinnati, USA. In India, the diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and co-infection with other enteric pathogens. These vaccines have therefore, also been tested in India.

NCT ID: NCT00263666 Completed - Clinical trials for Infections, Rotavirus

A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

Start date: March 16, 2005
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00258154 Completed - Rotavirus Disease Clinical Trials

V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

Start date: February 2006
Phase: Phase 3
Study type: Interventional

The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.

NCT ID: NCT00197210 Completed - Clinical trials for Infections, Rotavirus

A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Start date: December 2003
Phase: Phase 3
Study type: Interventional

The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

NCT ID: NCT00140686 Completed - Clinical trials for Infections, Rotavirus

To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

Start date: September 2004
Phase: Phase 3
Study type: Interventional

The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.