Clinical trials: Gastroenteritis Rotavirus
- Condition Gastroenteritis Rotavirus
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
Rotavirus Gastroenteritis
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
- Trial name
- NCT01177657
- Testing
- Stool sampling
- Where
- Brazil
- Volunteers
- 1,944 people
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus
Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.
- Trial name
- ROTAVAC5C (NCT04819412)
- Testing
- ROTAVAC®, ROTAVAC 5C -F1, ROTAVAC 5C -F2
- Volunteers
- 1,975 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
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 Infection, Viral Gastroenteritis Due to Rotavirus
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
- Trial name
- NCT01328925
- Testing
- Nitazoxanide
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Romark Laboratories L.C.
Infections, Rotavirus
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam.
- Trial name
- NCT00345956
- Testing
- Human rotavirus liquid vaccine
- Where
- 2 sites in Vietnam
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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, Rotavirus Vaccines
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
- Trial name
- NCT00432380
- Testing
- Rotarix™
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pediatric Gastroenteritis
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions.
- Trial name
- NCT01195844
- Testing
- Rotavirus Vaccine
- Volunteers
- 230 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Rotavirus Gastroenteritis
A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
- Trial name
- NCT02133690
- Testing
- Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
- Where
- 6 sites in India
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Rotavirus Infections, Gastroenteritis
ROTATEQ™ Post-Marketing Surveillance in the Philippines
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.
- Trial name
- NCT01357174
- Volunteers
- 915 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Rotaviral Gastroenteritis
Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates
The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates.
- Trial name
- NCT01201252
- Testing
- Stool sampling
- Where
- 3 sites in United Arab Emirates
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants.
- Trial name
- NCT01600092
- Testing
- RotaTeq™ experimental formulation, RotaTeq™ existing formulation
- Volunteers
- 1,020 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Infections, Rotavirus
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247).
- Trial name
- NCT00420316
- Testing
- Rotarix (primary vaccination study)
- Where
- 15 sites in Finland
- Volunteers
- 1,613 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of…
- Trial name
- NCT03474055
- Testing
- Liquid Rotavirus Vaccine
- Where
- 8 sites in India
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Rotavirus Gastroenteritis
PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
The Phase II clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in infants aged 6 to 12 weeks.
- Trial name
- NCT06967272
- Testing
- Oral hexavalent reassortant rotavirus attenuated live vaccine, Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Sinovac Life Sciences Co., Ltd.
Gastroenteritis
A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants
The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese…
- Trial name
- NCT06331156
- Testing
- HRV PCV-free, IPV
- Where
- 5 sites in China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline