Clinical trials: Rotavirus Gastroenteritis
Infections, Rotavirus
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human…
- Trial name
- NCT00329745
- Testing
- Rotarix™
- Where
- 4 sites in Singapore
- Volunteers
- 8,687 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
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).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- 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
Gastroenteritis
Rotavirus Vaccine in Premature Babies
This study will establish the duration of excretion of rotavirus vaccine in stool following vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.
- Trial name
- RotaNeo (NCT02252029)
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- University of Oxford
Hepatitis B
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
- Trial name
- NCT00429481
- Testing
- Rotarix
- Volunteers
- 2,464 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus, Acute Gastroenteritis
Effectiveness of Monovalent Rotavirus Vaccine (RV1)
To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and the Medical University of South Carolina…
- Trial name
- NCT01871038
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Immunogenicity of Rotavirus Vaccine
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide.
- Trial name
- NCT01199874
- Testing
- Rotavirus vaccine
- Where
- Pakistan
- Volunteers
- 1,140 people, healthy volunteers welcome
- Sponsor
- PATH
Rotavirus Gastroenteritis, Rotavirus Vaccines
ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings.
- Conditions
- Rotavirus Gastroenteritis, Rotavirus Vaccines, Antimicrobial Resistance (AMR), Antibiotic
- Trial name
- NCT06882070
- Testing
- Vaccine
- Where
- 2 sites in Ghana, Zambia
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rotavirus Gastroenteritis
Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of…
- Trial name
- NCT03474055
- Testing
- Liquid Rotavirus Vaccine
- Where
- 8 sites in India
- Volunteers
- 1,500 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
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
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Background: China's healthcare system for children faces significant challenges, particularly due to the limited pediatric service capacity of primary healthcare institutions.
- Conditions
- Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock, Hand-foot-and-mouth Disease, Acute Appendicitis
- Trial name
- NCT06699433
- Testing
- Virtual standardized patients (VSPs), Case teaching manuals, Case teaching videos
- Where
- 3 sites in China
- Volunteers
- 459 people, healthy volunteers welcome
- Sponsor
- Southern Medical University, China
Gastroenteritis, Rotavirus Infections
Surveillance of Rotavirus Gastroenteritis in Children <5 Years
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.
- Trial name
- NCT01363726
- Where
- Israel
- Volunteers
- 30,000 people
- Sponsor
- Soroka University Medical Center
Rotavirus Gastroenteritis
Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine
A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]in Indian infants.
- Trial name
- NCT01061658
- Testing
- Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine
- Where
- India
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Infections, Rotavirus
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
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…
- Trial name
- NCT00729001
- Testing
- Human Rotavirus Vaccine - two different formulations, Prevnar, IPOL
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
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.
- Trial name
- NCT01575197
- Testing
- Human Rotavirus Vaccine
- Where
- Ghana
- Volunteers
- 456 people, healthy volunteers welcome
- Sponsor
- PATH
Gastroenteritis Rotavirus
ROTATEQ Reexamination Study (V260-037)
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting…
- Trial name
- NCT01074242
- Volunteers
- 3,798 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotaviral Gastroenteritis
Evaluation of the Role of Vitamin D in Reducing the Severity and Duration of Rotavirus Infection in Iraqi Children
The aim of this study is to evaluate the effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital.
- Trial name
- NCT07167797
- Testing
- Vitamin D (Cholecalciferol ), Standard treatment for rotavirus
- Where
- Iraq
- Volunteers
- 60 people
- Sponsor
- University of Baghdad
Feasibility Study, Vaccine Immune Response
How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia
The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including…
- Conditions
- Feasibility Study, Vaccine Immune Response, Rota Virus Gastroenteritis, Transcriptomics
- Trial name
- Rota-Omics (NCT07626606)
- Testing
- Rotarix®,
- Where
- Zambia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia