Clinical trials: Gastroenteritis Rotavirus
Rotavirus Infections, Rotavirus Gastroenteritis
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
- Trial name
- NCT05621655
- Testing
- Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine, High dose Recombinant Trivalent Subunit Rotavirus Vaccine
- Where
- 2 sites in China
- Volunteers
- 1,512 people, healthy volunteers welcome
- Sponsor
- MAXVAX Biotechnology Limited Liability Company
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
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 Gastroenteritis
To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus
Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.
- Trial name
- ROTAVAC5C (NCT04819412)
- Testing
- ROTAVAC®, ROTAVAC 5C -F1, ROTAVAC 5C -F2
- Volunteers
- 1,975 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Pediatric Gastroenteritis
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions.
- Trial name
- NCT01195844
- Testing
- Rotavirus Vaccine
- Volunteers
- 230 people
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Gastroenteritis
Estimation of the Burden of Rotavirus Gastroenteritis (RV GE) in Children Less Than 5 Years in Greece
The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data.
- Trial name
- NCT00751686
- Testing
- Stool sample, Data collection
- Where
- 6 sites in Greece
- Volunteers
- 128 people
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants
Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in children aged less than 5 years worldwide and are reported to infect nearly every child by the age of 5 years.
- Trial name
- HSRV (NCT02728869)
- Testing
- Heat Stable Rotavirus (HSRV) Vaccine, RotaTeq®
- Where
- Bangladesh
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.
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
Infections, Rotavirus
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants
To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
- Trial name
- NCT00425737
- Testing
- Rotarix
- Volunteers
- 405 people, healthy volunteers welcome
- 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
Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than…
- Trial name
- NCT00137930
- Testing
- Live attenuated rotavirus vaccine
- Where
- 5 sites in Finland
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gastroenteritis, Diarrhea
The Treatment Effect of Bio-Three on Children With Enteritis
Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are infected by rotavirus or salmonella. Base on the past researches, there is benefit effect of probiotics on patients with diarrhea or acute…
- Trial name
- Bio-three (NCT01480947)
- Testing
- Bio-three
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Kaohsiung Veterans General Hospital.
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
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, Diphtheria
A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.
- Conditions
- Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01003431
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP), Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Rotavirus Infection, Viral Gastroenteritis Due to Rotavirus
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
- Trial name
- NCT01328925
- Testing
- Nitazoxanide
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Romark Laboratories L.C.
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
Infections, Rotavirus, Rotavirus Vaccines
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
- Trial name
- NCT00432380
- Testing
- Rotarix™
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline