Clinical trials: Severe Rotavirus Gastroenteritis
Viral Gastroenteritis Due to Rotavirus
A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E
The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe rotavirus gastroenteritis, in comparison…
- Trial name
- ROTAVAC (NCT01305109)
- Testing
- ORV 116E
- Where
- 3 sites in India
- Volunteers
- 6,800 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Severe Rotavirus Gastroenteritis
Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger
The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV.
- Trial name
- ROSE (NCT02145000)
- Testing
- Rotavirus vaccine (BRV-PV)
- Where
- Niger
- Volunteers
- 6,586 people, healthy volunteers welcome
- Sponsor
- Epicentre
Rotavirus Gastroenteritis
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
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.
- Trial name
- NCT01177657
- Testing
- Stool sampling
- Where
- Brazil
- Volunteers
- 1,944 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
- Trial name
- NCT01177826
- Testing
- Sample collection
- Where
- 29 sites in Belgium
- Volunteers
- 643 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
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…
- Trial name
- NCT01978223
- Testing
- Stool sample collection
- Sponsor
- GlaxoSmithKline
Viral Gastroenteritis Due to Rotavirus, Gastroenteritis
Impact of Rotavirus Vaccine Introduction for South Australian Children
This project aims to assess the impact of rotavirus vaccine introduction on severe gastroenteritis in South Australian children.
- Trial name
- NCT01472575
- Where
- Australia
- Volunteers
- 1,200 people
- Sponsor
- Associate Professor Helen Marshall
Rotavirus Gastroenteritis, Infections, Rotavirus
Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden
This study aims to estimate the burden of RV GE. The study will focus on children hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household contacts of children hospitalized with RV GE.
- Trial name
- NCT00489567
- Testing
- Blood sample collection
- Volunteers
- 642 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which…
- Trial name
- NCT00653198
- Testing
- No intervention
- Where
- Panama
- Volunteers
- 885 people
- Sponsor
- GlaxoSmithKline
Rotavirus Severe Gastroenteritis
Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants
This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in…
- Trial name
- NCT00655187
- Testing
- Collection of information, Collection of stool samples
- Where
- Singapore
- Volunteers
- 1,270 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic drifts (point mutations) in the vaccine…
- Trial name
- NCT01339221
- Testing
- Stool samples
- Where
- 11 sites in Belgium
- Volunteers
- 72 people
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
- Trial name
- NCT02133690
- Testing
- Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
- Where
- 6 sites in India
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Rotavirus Gastroenteritis, Young Taiwanese Children
Hospital-based Surveillance of Rotavirus Gastroenteritis in Young Taiwanese Children
Rotavirus remains among the leading causes of pediatric gastroenteritis requiring hospitalization in the world. Surveillance studies revealed that more than 90% of the global circulating rotavirus strains were predominated by…
- Trial name
- NCT03550937
- Where
- 10 sites in Taiwan
- Volunteers
- 5,040 people
- Sponsor
- National Taiwan University Hospital
Gastroenteritis, Acute Gastroenteritis
Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation)
The GASTROVIM research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess…
- Trial name
- Gastrovimc (NCT02902445)
- Testing
- rotavirus rapid screen test, polymorphism exploration
- Where
- France
- Volunteers
- 611 people
- Sponsor
- Nantes University Hospital
Rotavirus Infection of Children
A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg…
- Trial name
- NCT04010448
- Testing
- TV P2-VP8, Rotarix
- Where
- Zambia
- Volunteers
- 8,200 people, healthy volunteers welcome
- Sponsor
- PATH