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Infections, Rotavirus clinical trials

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NCT ID: NCT03954743 Completed - Clinical trials for Infections, Rotavirus

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start date: July 19, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.

NCT ID: NCT02914184 Completed - Clinical trials for Infections, Rotavirus

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

NCT ID: NCT02153333 Completed - Clinical trials for Infections, Rotavirus

Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™

Start date: February 2014
Phase: N/A
Study type: Observational

This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.

NCT ID: NCT01978223 Withdrawn - Clinical trials for Infections, Rotavirus

Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis

Start date: December 2014
Phase: N/A
Study type: Observational

This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.

NCT ID: NCT01915888 Completed - Clinical trials for Infections, Rotavirus

Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination

Start date: August 2013
Phase: N/A
Study type: Observational

This study aims to estimate the clinical and cost impact of Rotarix vaccinations among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population. The impact of incomplete and complete Rotarix vaccination will also be examined, overall and stratified by calendar time of Rotarix vaccination (e.g., 2008 onward).

NCT ID: NCT01733862 Completed - Clinical trials for Infections, Rotavirus

Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis

Start date: November 27, 2012
Phase:
Study type: Observational

This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City (administrative district), Japan, where RV vaccines have been introduced since November 2011 and financial support for vaccination costs by Nagoya city, Japan have been implemented from October 2012.

NCT ID: NCT01733849 Completed - Clinical trials for Infections, Rotavirus

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

Start date: December 2012
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01682005 Completed - Clinical trials for Infections, Rotavirus

Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotavirus (RV) Vaccination

Start date: August 2012
Phase: N/A
Study type: Observational

This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq® and Rotarix®) among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population. The impact of incomplete and complete RV vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months, 8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).

NCT ID: NCT01636739 Completed - Clinical trials for Infections, Rotavirus

Special Drug Use Investigation for ROTARIX®

Start date: July 2012
Phase: N/A
Study type: Observational

This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.

NCT ID: NCT01636193 Completed - Clinical trials for Infections, Rotavirus

Drug Use Investigation for ROTARIX®

Start date: June 2012
Phase: N/A
Study type: Observational

This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.