Clinical trials: Rotavirus Infections
Infections, Rotavirus
Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants
The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.
- Trial name
- NCT01107587
- Testing
- GSK Biologicals' human rotavirus vaccine 444563
- Where
- China
- Volunteers
- 50 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
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 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
Infections, Rotavirus
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan.
- Trial name
- NCT03954743
- Testing
- PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine, Lyophilized formulation of GSK's oral live attenuated HRV vaccine
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 1,351 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK…
- Trial name
- NCT00197210
- Testing
- Rotavirus
- Where
- 4 sites in Singapore
- Volunteers
- 10,708 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
- Trial name
- NCT00334607
- Testing
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Where
- 42 sites in United States
- Volunteers
- 484 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Intussusception, Rotavirus Infections
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses.
- Trial name
- NCT02542462
- Testing
- Rotarix®,, Rotarix®, with other routine vaccines, RotaTeq®,
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Poliomyelitis, Tropical Enteropathy
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
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…
- Trial name
- NCT01571505
- Testing
- IPV vaccination
- Where
- India
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Infections, Rotavirus
Study to Evaluate the Safety of Rotarix™ in Chinese Children
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.
- Trial name
- NCT01086436
- Testing
- Rotarix ™
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Infections, Rotavirus
Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
This study aims to estimate the clinical and cost impact of Rotarix vaccinations among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population.
- Trial name
- NCT01915888
- Testing
- Data interpretation
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections
Rotavirus Efficacy and Safety Trial (REST)(V260-006)
This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.
- Trial name
- NCT00090233
- Testing
- Rotateq™
- Volunteers
- 69,274 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Infections
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) for intradermal administration in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series.
- Trial name
- NCT06962904
- Testing
- 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV), 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
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
Infections, Rotavirus
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the…
- Trial name
- NCT00420745
- Testing
- Rotarix™
- Where
- 31 sites in France, Poland and 2 more
- Volunteers
- 1,009 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus
Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants
The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix…
- Trial name
- NCT02907216
- Testing
- Squarekids, Rotarix
- Where
- 11 sites in Japan
- Volunteers
- 292 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India
Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by…
- Trial name
- NCT00289172
- Testing
- Live attenuated human rotavirus vaccine
- Where
- 4 sites in India
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections, Intestinal Bacteria Flora Disturbance
The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.
- Conditions
- Rotavirus Infections, Intestinal Bacteria Flora Disturbance, Reaction - Vaccine Nos, Tetanus
- Trial name
- Rota-biome (NCT02538211)
- Testing
- Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine
- Where
- Netherlands
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least…
- Trial name
- NCT00750893
- Testing
- Rotarix or Rotarix liquid formulation
- Where
- South Korea
- Volunteers
- 3,111 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline