Clinical trials: Rotavirus Vaccine
Infections, Rotavirus
Drug Use Investigation for ROTARIX®
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
- Trial name
- NCT01636193
- Testing
- Oral Rotarix®, Data collection
- Volunteers
- 1,607 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Intussusception (IS), Rotavirus Vaccines
Intussusception Surveillance After Rotarix Introduction in Mexico
GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico.
- Trial name
- NCT00595205
- Testing
- Hospital log review.
- Where
- Mexico
- Volunteers
- 786 people
- Sponsor
- GlaxoSmithKline
Rotavirus Vaccine
Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
Assess the immunological behavior of children from 2 months of age that receive one out of seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 - Rotarix plus sterile water) and Group 2…
- Trial name
- NCT02193061
- Testing
- Rotarix, RotaTeq
- Where
- Mexico
- Volunteers
- 1,498 people, healthy volunteers welcome
- Sponsor
- National Institute of Pediatrics, Mexico
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
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which…
- Trial name
- NCT00653198
- Testing
- No intervention
- Where
- Panama
- Volunteers
- 885 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of…
- Trial name
- NCT00533507
- Testing
- Synflorix, Infanrix hexa, Rotarix
- Where
- 3 sites in Taiwan
- Volunteers
- 230 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
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, 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
Rotavirus Gastroenteritis, Gastroenteritis
Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia
This study aims to monitor the incidence rates and duration of hospitalisations for rotavirus gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to 2009, in children < 5 years of age after the…
- Trial name
- NCT01236066
- Testing
- Database analysis
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Rotavirus Infections, Gastroenteritis
Vaccine Effectiveness of RV1 in a Naïve Population
Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would amount to 13,600 Canadian children < 5 years.
- Conditions
- Rotavirus Infections, Gastroenteritis, Diarrhea
- Trial name
- NCT01467037
- Testing
- No intervention done
- Where
- 3 sites in Canada
- Volunteers
- 374 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
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 Infection
Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection
This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged…
- Trial name
- NCT04626856
- Testing
- Low dosage IRV on a 0- and 28-day schedule, Medium dosage IRV on a 0- and 28-day schedule, High dosage IRV on a 0- and 28-day schedule
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences
Rotavirus Gastroenteritis
Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island
The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the…
- Trial name
- NCT01026779
- Where
- United States
- Volunteers
- 803 people
- Sponsor
- Lifespan
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
V260 Registration Study (V260-013)(COMPLETED)
Immunogenicity and Safety of V260 in Healthy Infants in Korea
- Trial name
- NCT00166517
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Infections, Rotavirus
Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy adults aged 18 to 45 years in China.
- Trial name
- NCT01162590
- Testing
- Rotarix ™
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Disease
V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)
The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.
- Trial name
- NCT00258154
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Infanrix(tm) Hexa
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC