Clinical trials: Gastroenteritis Rotavirus
Infections, Rotavirus
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe…
- Trial name
- NCT00241644
- Testing
- Rotarix™
- Where
- 13 sites in Malawi, South Africa
- Volunteers
- 2,089 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Gastroenteritis, Dehydration
Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
This study aims to determine the contribution of rotavirus infection as a cause of gastroenteritis requiring hospitalization in children younger than 5 years of age.
- Trial name
- NCT01321216
- Where
- 4 sites in Lebanon
- Volunteers
- 1,555 people
- Sponsor
- American University of Beirut Medical Center
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
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine
- Trial name
- NCT00363545
- Testing
- Lyophilized formulation of HRV vaccine, Liquid formulation of HRV vaccine
- Where
- 3 sites in Panama
- Volunteers
- 1,274 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
Gastroenteritis
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK) oral live attenuated human rotavirus (HRV)…
- Trial name
- NCT06025695
- Testing
- GSK's liquid oral live attenuated HRV, PCV-free liquid formulation of GSK's oral live attenuated HRV
- Where
- 12 sites in China
- Volunteers
- 2,000 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, 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
Infections, Rotavirus, Rotavirus Vaccines
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the…
- Trial name
- NCT00353366
- Testing
- Rotarix, Data collection
- Where
- 18 sites in Philippines
- Volunteers
- 1,439 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa.
- Trial name
- NCT01575197
- Testing
- Human Rotavirus Vaccine
- Where
- Ghana
- Volunteers
- 456 people, healthy volunteers welcome
- Sponsor
- PATH
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
Diarrhea, Gastroenteritis
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months).
- Trial name
- NCT01960725
- Testing
- RV5 (Pentavalent Rotavirus Vaccine)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dennis Clements
Rotavirus Gastroenteritis
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants.
- Trial name
- NCT02062385
- Testing
- V260, OPV, DTaP
- Volunteers
- 4,040 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
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
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, Acute Gastroenteritis
Effectiveness of Monovalent Rotavirus Vaccine (RV1)
To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and the Medical University of South Carolina…
- Trial name
- NCT01871038
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
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