Clinical trials: Rotavirus Infections
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
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
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 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
Infections, Rotavirus
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
- Trial name
- NCT00140686
- Testing
- Rotavirus (vaccine)
- Where
- 101 sites in Czechia, Finland and 4 more
- Volunteers
- 3,994 people, healthy volunteers welcome
- 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
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 Infections
Consistency Lots Vaccine Study (V260-009)
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
- Trial name
- NCT00092456
- Testing
- rotavirus vaccine, live, oral, pentavalent
- Volunteers
- 793 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Infections, Rotavirus
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
- Trial name
- NCT00383903
- Testing
- HRV vaccine
- Where
- 6 sites in South Africa
- Volunteers
- 472 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Vaccination, Rotavirus Infections
A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
A two-phases study will be carried out with the following aims 1. st phase (2018-2020) To investigate the vaccination coverage for Rotavirus vaccine (RV) in Campania Region together with other pediatric vaccinations scheduled in…
- Conditions
- Vaccination, Rotavirus Infections, Meningococcal Infections
- Trial name
- STORM (NCT05212935)
- Testing
- Rotavirus Vaccine
- Volunteers
- 2,000 people
- Sponsor
- Federico II University
Infections, Rotavirus
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants.
- Trial name
- NCT00263666
- Testing
- Rotarix, Tritanrix-HB+Hib, Polio Sabin
- Where
- 6 sites in South Africa
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
HIV Infection, Rotavirus Infection
Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries.
- Trial name
- NCT00880698
- Testing
- RotaTeq
- Where
- 6 sites in Botswana, Tanzania and 2 more
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infections, Rotavirus, Rotavirus Vaccines
Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City (administrative district), Japan, where RV vaccines have been introduced since November 2011 and financial support for vaccination costs by…
- Trial name
- NCT01733862
- Testing
- Data collection
- Where
- 7 sites in Japan
- Volunteers
- 5,394 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of…
- Trial name
- NCT00875641
- Testing
- Health Insurance Database
- Where
- United States
- Volunteers
- 390,659 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 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
Rotavirus Gastroenteritis, Diphtheria
A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.
- Conditions
- Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01003431
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP), Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC