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Infections, Rotavirus clinical trials

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NCT ID: NCT01110044 Withdrawn - Clinical trials for Infections, Rotavirus

Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Start date: April 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.

NCT ID: NCT01107587 Completed - Clinical trials for Infections, Rotavirus

Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants

Start date: April 13, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.

NCT ID: NCT01086436 Completed - Clinical trials for Infections, Rotavirus

Study to Evaluate the Safety of Rotarix™ in Chinese Children

Start date: March 13, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.

NCT ID: NCT00969228 Completed - Clinical trials for Infections, Rotavirus

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

Start date: August 25, 2009
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00938327 Completed - Clinical trials for Infections, Rotavirus

Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants

Start date: August 3, 2009
Phase: N/A
Study type: Observational

This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.

NCT ID: NCT00875641 Completed - Clinical trials for Infections, Rotavirus

Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States

Start date: April 20, 2009
Phase:
Study type: Observational

This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with Rotarix within 60 days of vaccination in a real life setting (routine use) in the US. This study will also include monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination. This study involves three cohorts, one exposed and two control cohorts: infants who receive Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B). This is a combined prospective and retrospective cohort study. Prospective component of the study identifies and compares study outcomes following Rotarix and IPV vaccination in the Exposed cohort and Unexposed cohort A, respectively. Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.

NCT ID: NCT00779779 Completed - Clinical trials for Infections, Rotavirus

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

Start date: November 22, 2008
Phase:
Study type: Observational

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).

NCT ID: NCT00757770 Completed - Clinical trials for Infections, Rotavirus

Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

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

The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.

NCT ID: NCT00750893 Completed - Clinical trials for Infections, Rotavirus

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

Start date: September 2, 2008
Phase:
Study type: Observational

This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.

NCT ID: NCT00729001 Completed - Clinical trials for Infections, Rotavirus

Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

Start date: November 2000
Phase: Phase 2
Study type: Interventional

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.