Clinical trials: Diarrhea Rotavirus
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
Rotavirus, Diarrhea
Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam
The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City…
- Trial name
- NCT03587389
- Testing
- Rotarix vaccine
- Where
- Vietnam
- Volunteers
- 818 people, healthy volunteers welcome
- Sponsor
- Oxford University Clinical Research Unit, Vietnam
Diarrhea Rotavirus
Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization…
- Trial name
- NCT02286895
- Testing
- pentavalent rotavirus vaccine (PRV), measles vaccine (MV), yellow fever vaccine (YFV)
- Where
- Mali
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PATH
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
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
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.
Infections, Rotavirus
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe…
- Trial name
- NCT00241644
- Testing
- Rotarix™
- Where
- 13 sites in Malawi, South Africa
- Volunteers
- 2,089 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Diarrhea, Vaccine Virus Shedding
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased…
- Conditions
- Rotavirus Diarrhea, Vaccine Virus Shedding, Tropical Enteropathy
- Trial name
- PROVIDE (NCT01375647)
- Testing
- IPV (inactivated polio vaccine), Rotarix
- Where
- Bangladesh
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- University of Vermont
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)
Diarrhea, Diarrhea Rotavirus
Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia
The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks of age.
- Trial name
- ROTAVAC (NCT03602053)
- Testing
- ROTAVAC®, ROTAVAC 5D, Rotarix®
- Where
- Zambia
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Diarrhea
Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old
This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged 8-20 weeks at three…
- Trial name
- NCT00439660
- Testing
- Oral Rotavirus Vaccine 116E Live Attenuated
- Where
- India
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Diarrhea, Gastroenteritis
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months).
- Trial name
- NCT01960725
- Testing
- RV5 (Pentavalent Rotavirus Vaccine)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dennis Clements
Diarrhea, Diarrhea Rotavirus
Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa
Despite the widespread introduction of vaccines against Rotavirus, Rotavirus continues to be a cause of significant morbidity and mortality in the developing world.
- Trial name
- NCT04658914
- Testing
- Rotarix, Trivalent P2-VP8
- Where
- Zambia
- Volunteers
- 720 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Rotavirus Infections, Diarrhea
Phase II Clinical Trial of the Inactivated Rotavirus Vaccine
This study is a randomized, double-blinded, placebo-controlled phase 2 clinical trial to evaluate the immunogenicity and safety of Inactivated Rotavirus Vaccine (IRV) in children (aged 2-71 months).
- Trial name
- NCT06080906
- Testing
- IRV on a 0- and 28-day schedule, IRV on a 0-, 28- and 56-day schedule
- Where
- China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
Infections, Rotavirus
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV…
- Trial name
- NCT00382772
- Testing
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Where
- 12 sites in Finland
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Diarrhea, Vomit
Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults
The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
- Conditions
- Diarrhea, Vomit, Fever, Nausea
- Trial name
- NCT01375907
- Testing
- Rotavin
- Where
- Vietnam
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- National Institute of Hygiene and Epidemiology, Vietnam
Diarrhoea
Causes of Rotavirus Vaccine Failure in Zambian Children
Zambia recently introduced routine infant immunization against rotavirus - the most important cause of severe gastroenteritis and diarrhoea mortality in children.
- Trial name
- NCT01886833
- Where
- Zambia
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Diarrhea, Fever
A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam.
- Conditions
- Diarrhea, Fever, Nausea, Vomit
- Trial name
- NCT01377571
- Testing
- Rotarix
- Where
- Vietnam
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute of Hygiene and Epidemiology, Vietnam
Diarrhea, Diarrhea Rotavirus
Phase III Study of Liquid Formulation of ROTAVIN
This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second…
- Trial name
- NCT03703336
- Testing
- ROTAVIN (liquid formulation), ROTAVIN-M1 (frozen formulation)
- Where
- 2 sites in Vietnam
- Volunteers
- 825 people, healthy volunteers welcome
- Sponsor
- Center for Research and Production of Vaccines and Biologicals, Vietnam