Clinical trials: Rotavirus Vaccine
Infections, Rotavirus, Rotavirus Vaccines
Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free…
- Trial name
- NCT02914184
- Testing
- HRV PCV-free liquid vaccine, Rotarix
- Where
- 66 sites in United States, Costa Rica and 6 more
- Volunteers
- 1,612 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections, Rotavirus Gastroenteritis
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
- Trial name
- NCT05621655
- Testing
- Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine, High dose Recombinant Trivalent Subunit Rotavirus Vaccine
- Where
- 2 sites in China
- Volunteers
- 1,512 people, healthy volunteers welcome
- Sponsor
- MAXVAX Biotechnology Limited Liability Company
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)
Rotavirus Gastroenteritis, Rotavirus Vaccines
ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings.
- Conditions
- Rotavirus Gastroenteritis, Rotavirus Vaccines, Antimicrobial Resistance (AMR), Antibiotic
- Trial name
- NCT06882070
- Testing
- Vaccine
- Where
- 2 sites in Ghana, Zambia
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Gastroenteritis Rotavirus
ROTATEQ Reexamination Study (V260-037)
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting…
- Trial name
- NCT01074242
- Volunteers
- 3,798 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Dengue, Chikungunya
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics.
- Conditions
- Dengue, Chikungunya, Zika Virus Infection, Japanese Encephalitis
- Trial name
- RACSMEI (NCT07358910)
- Where
- Cambodia
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur du Cambodge
Severe Rotavirus Gastroenteritis
Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger
The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV.
- Trial name
- ROSE (NCT02145000)
- Testing
- Rotavirus vaccine (BRV-PV)
- Where
- Niger
- Volunteers
- 6,586 people, healthy volunteers welcome
- Sponsor
- Epicentre
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
Gastrointestinal Diseases
Evaluation of Universal Rotavirus Vaccination Program
Two rotavirus vaccines have been authorized for use in Canada: RotaTeq®, Merck Frost Canada, Inc. and Rotarix®, Glaxo Smith Kline (GSK).
- Trial name
- NCT01273077
- Where
- Canada
- Volunteers
- 12,705 people, healthy volunteers welcome
- Sponsor
- Dalhousie University
Rotavirus Gastroenteritis
Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5…
- Trial name
- NCT00169455
- Testing
- Live attenuated human rotavirus vaccine
- Where
- 2 sites in Thailand
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Diarrhea, Fever
A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam.
- Conditions
- Diarrhea, Fever, Nausea, Vomit
- Trial name
- NCT01377571
- Testing
- Rotarix
- Where
- Vietnam
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute of Hygiene and Epidemiology, Vietnam
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
Rotavirus Infections
Rotavirus Vaccine Produced by Butantan Institute
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
- Trial name
- NCT00981669
- Testing
- rotavirus vaccine
- Where
- Brazil
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Butantan Institute
Infections, Rotavirus
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
- Trial name
- NCT00385320
- Testing
- HRV vaccine
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo.
- Trial name
- NCT00396630
- Testing
- Rotarix
- Where
- Dominican Republic
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
- Trial name
- NCT00969228
- Testing
- Rotarix ™
- Where
- 18 sites in South Korea
- Volunteers
- 684 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
Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants
Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in children aged less than 5 years worldwide and are reported to infect nearly every child by the age of 5 years.
- Trial name
- HSRV (NCT02728869)
- Testing
- Heat Stable Rotavirus (HSRV) Vaccine, RotaTeq®
- Where
- Bangladesh
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.
Infections, Rotavirus
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.
- Trial name
- NCT00370318
- Testing
- 10 valent pneumococcal conjugate vaccine, Infanrix Hexa, Rotarix
- Where
- 10 sites in Czechia
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline