Clinical trials: Rotavirus
Rotavirus Infection, Vaccine Response Impaired
The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries.
- Conditions
- Rotavirus Infection, Vaccine Response Impaired, Vaccine Virus Shedding
- Trial name
- NCT02992197
- Testing
- Rotarix, dose 1, Rotarix, dose 2
- Where
- Bangladesh
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- University of Vermont
Rotavirus Gastroenteritis
Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab
The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) to determine the population effectiveness of…
- Trial name
- NCT00737503
- Testing
- Rotavirus Vaccine (ROTARIX)
- Where
- Bangladesh
- Volunteers
- 4,550 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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.
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
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
Infections, Rotavirus
Study to Evaluate the Safety of Rotarix™ in Chinese Children
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.
- Trial name
- NCT01086436
- Testing
- Rotarix ™
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Epidemiology of Rotavirus Infection in North India Community
This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.
- Trial name
- NCT01508533
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Society for Applied Studies
Rotavirus
A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)
This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response to RotaTeq™ /placebo in subjects of 65 to 80 years of age.
- Trial name
- NCT00836498
- Testing
- Comparator: RotaTeq
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Gastroenteritis
A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers
This is a Phase I study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy Indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration…
- Trial name
- NCT01091298
- Testing
- Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
- Where
- India
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
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
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines
- Trial name
- NCT04185545
- Testing
- Rotavirus RV3 Vaccine (Bio Farma)
- Where
- 21 sites in Indonesia
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Pertussis Immunisation, Diphtheria Immunisation
Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Primary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: To describe the immunogenicity profile…
- Conditions
- Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation, Hepatitis B Immunisation
- Trial name
- NCT04429295
- Testing
- DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus), DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b), Inactivated Poliomyelitis Vaccine
- Where
- 3 sites in Thailand
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Rotavirus
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after…
- Trial name
- NCT01198769
- Testing
- Rotarix TM
- Where
- Taiwan
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diarrhoeal Disease
Development of a Live Attenuated Rotavirus Vaccine as a Human Infection Challenge Model
The impact of licensed rotavirus vaccines in LMICs is limited by their lower immunogenicity and efficacy in these settings. Improved vaccines and vaccination schedules would result in substantially greater reductions in infant…
- Trial name
- NCT04123119
- Testing
- Rotavirus vaccine
- Where
- Zambia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia