Clinical trials: Gastroenteritis 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
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
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
Gastroenteritis, Rotavirus
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
- Trial name
- NCT00496054
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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
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
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
Rotavirus, Gastroenteritis
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
- Trial name
- NCT00718237
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
- Volunteers
- 762 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Gastroenteritis
The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy, Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants.
- Trial name
- NCT05958771
- Testing
- ROTAVAC 5D
- Where
- 16 sites in Chile
- Volunteers
- 4,270 people, healthy volunteers welcome
- Sponsor
- University of Chile
Infections, Rotavirus
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
- Trial name
- NCT00757770
- Testing
- Rotarix
- Where
- 4 sites in Colombia, Mexico and 1 more
- Volunteers
- 854 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections, Gastroenteritis
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.
- Trial name
- NCT00130832
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Oral Poliovirus Vaccine (OPV), Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
- Volunteers
- 735 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
Gastroenteritis
A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants
The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese…
- Trial name
- NCT06331156
- Testing
- HRV PCV-free, IPV
- Where
- 5 sites in China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)
This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants.
- Trial name
- NCT04481191
- Testing
- RotaTeq (V260), IPV
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Infection of Children
A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg…
- Trial name
- NCT04010448
- Testing
- TV P2-VP8, Rotarix
- Where
- Zambia
- Volunteers
- 8,200 people, healthy volunteers welcome
- Sponsor
- PATH
Rotavirus Gastroenteritis
Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement
Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The investigators hypothesize that use of a food based prophylactic will decrease incidence of rotavirus infection in young children in south…
- Trial name
- NCT01265355
- Testing
- Anti-rotavirus protein, Maltodextrin
- Where
- India
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Christian Medical College, Vellore, India
Infections, Rotavirus
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
- Trial name
- NCT00938327
- Testing
- Rotarix™
- Where
- 12 sites in India
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam
- Trial name
- NCT04596696
- Testing
- Rotavac
- Where
- Vietnam
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited