Clinical trials: Gastroenteritis Rotavirus
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
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
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.
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
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
Rotavirus Gastroenteritis
A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years…
- Trial name
- NCT00953056
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Gastroenteritis
Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
- Trial name
- NCT02584816
- Testing
- BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV, BRV-PV Lot C + DPT-HepB-Hib + OPV
- Where
- 10 sites in India
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Rotavirus Gastroenteritis
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants.
- Trial name
- NCT01600092
- Testing
- RotaTeq™ experimental formulation, RotaTeq™ existing formulation
- Volunteers
- 1,020 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Infections, Gastroenteritis
ROTATEQ™ Post-Marketing Surveillance in the Philippines
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.
- Trial name
- NCT01357174
- Volunteers
- 915 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Gastroenteritis
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants.
- Trial name
- NCT02062385
- Testing
- V260, OPV, DTaP
- Volunteers
- 4,040 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Gastroenteritis
Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis
This study evaluates a new drug, new enteroadsorbent polymethylsiloxane (Enterosgel) in the treatment of rotavirus gastroenteritis in children.
- Trial name
- NCT04116307
- Testing
- Polymethylsiloxane, Lactobacillus reuteri
- Where
- Croatia
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- University Hospital for Infectious Diseases, Croatia
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Viral Gastroenteritis Due to Rotavirus
Optimising Rotavirus Vaccine in Aboriginal Children
Australian Indigenous children, particularly those living in remote communities, suffer a disproportionately high burden of rotavirus gastroenteritis disease.
- Trial name
- ORVAC (NCT02941107)
- Testing
- Rotarix (RV1)
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Telethon Kids Institute