Clinical trials: Rotavirus
Rotavirus Infections
Dose Confirmation Efficacy Study (V260-007)
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
- Trial name
- NCT00092443
- Testing
- RotaTeq™, rotavirus vaccine, live, oral, pentavalent
- Volunteers
- 1,312 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Rotavirus
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
- Trial name
- NCT00139347
- Testing
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Where
- 17 sites in Argentina, Brazil and 4 more
- Volunteers
- 6,360 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
Rotavirus Infections
Surveillance of Hospitalizations Due to Rotavirus Infections Among Children From Israel
Objectives 1. To determine the burden and characteristics of rotavirus-associated hospitalizations among children under five years of age of northern Israel 2.
- Trial name
- NCT00484952
- Where
- 2 sites in Israel
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
Infections, Rotavirus
Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than…
- Trial name
- NCT00134732
- Testing
- Live attenuated human rotavirus vaccine
- Where
- 6 sites in South Korea
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diarrhea, Diarrhea Rotavirus
Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa
Despite the widespread introduction of vaccines against Rotavirus, Rotavirus continues to be a cause of significant morbidity and mortality in the developing world.
- Trial name
- NCT04658914
- Testing
- Rotarix, Trivalent P2-VP8
- Where
- Zambia
- Volunteers
- 720 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Rotavirus Vaccine
Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
Assess the immunological behavior of children from 2 months of age that receive one out of seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 - Rotarix plus sterile water) and Group 2…
- Trial name
- NCT02193061
- Testing
- Rotarix, RotaTeq
- Where
- Mexico
- Volunteers
- 1,498 people, healthy volunteers welcome
- Sponsor
- National Institute of Pediatrics, Mexico
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.
Evaluation of a Rotavirus Vaccine
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers.
- Trial name
- NCT02109484
- Testing
- P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg, P2-VP8 Subunit Vaccine 60mcg
- Where
- South Africa
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- PATH
Diarrhea Rotavirus
Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization…
- Trial name
- NCT02286895
- Testing
- pentavalent rotavirus vaccine (PRV), measles vaccine (MV), yellow fever vaccine (YFV)
- Where
- Mali
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PATH
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
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
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
Innate Immune Response
Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.
- Trial name
- PPIR (NCT01700127)
- Testing
- Breastfeeding
- Where
- India
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Society for Applied Studies
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
Rotavirus Infections
Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus…
- Trial name
- NCT00757926
- Testing
- Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]
- Where
- India
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Infections, Rotavirus
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
- Trial name
- NCT00757770
- Testing
- Rotarix
- Where
- 4 sites in Colombia, Mexico and 1 more
- Volunteers
- 854 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam.
- Trial name
- NCT03367559
- Testing
- ROTAVAC®
- Where
- Vietnam
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
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
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