Clinical trials: Infections, Rotavirus
Rotavirus Gastroenteritis, Infections, Rotavirus
Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden
This study aims to estimate the burden of RV GE. The study will focus on children hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household contacts of children hospitalized with RV GE.
- Trial name
- NCT00489567
- Testing
- Blood sample collection
- Volunteers
- 642 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh
The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).
- Trial name
- NCT00139334
- Testing
- Rotavirus
- Where
- Bangladesh
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diarrhea, Rotavirus Infection
Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children
The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.
- Trial name
- NCT00981877
- Testing
- GB (Florestor), GRALB
- Where
- Bolivia
- Volunteers
- 76 people
- Sponsor
- Centro Pediatrico Albina de Patino
Infections, Rotavirus
Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.
- Trial name
- NCT01171963
- Testing
- GSK Biologicals' liquid human rotavirus vaccine 444563, Infanrix™, Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
- Where
- 4 sites in China
- Volunteers
- 3,340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Rotavirus Infection
Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization
The first multicenter prospective, randomized, double-blind, placebo-controlled clinical trial of the pentavalent live vaccine for RVI prevention was conducted in Russia among healthy infants aged 2 months at the time of the…
- Trial name
- NCT05032391
- Testing
- The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)
- Where
- 2 sites in Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Limited Liability Company Pharm Aid
Infections, Rotavirus
Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotavirus (RV) Vaccination
This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq® and Rotarix®) among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population.
- Trial name
- NCT01682005
- Testing
- Data interpretation
- Volunteers
- 1 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
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
Rotavirus Infection
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight…
- Trial name
- NCT01266850
- Testing
- Rotarix®, RotaTeq®
- Where
- 13 sites in United States
- Volunteers
- 1,384 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rotavirus Infections
To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
"The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.
- Trial name
- NCT00346892
- Testing
- Rotavirus (vaccine)
- Where
- South Africa
- Volunteers
- 450 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
Acute Diarrheal Disease, Rotavirus Infection
Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile
The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from…
- Trial name
- NCT00895492
- Where
- 2 sites in Chile
- Volunteers
- 967 people
- Sponsor
- University of Chile
Rotavirus Infections, Reaction - Vaccine Nos
Does the Fecal Microbiome Influence Rotarix Immunogenicity
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan.
- Conditions
- Rotavirus Infections, Reaction - Vaccine Nos, Intestinal Bacteria Flora Disturbance
- Trial name
- NCT02220439
- Volunteers
- 76 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Infections, Rotavirus
Special Drug Use Investigation for ROTARIX®
This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.
- Trial name
- NCT01636739
- Testing
- Oral Rotarix®, Data collection
- Volunteers
- 10,982 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium
This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in…
- Trial name
- NCT01592838
- Testing
- Data collection
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Rotaviral Gastroenteritis
Evaluation of the Role of Vitamin D in Reducing the Severity and Duration of Rotavirus Infection in Iraqi Children
The aim of this study is to evaluate the effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital.
- Trial name
- NCT07167797
- Testing
- Vitamin D (Cholecalciferol ), Standard treatment for rotavirus
- Where
- Iraq
- Volunteers
- 60 people
- Sponsor
- University of Baghdad
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