Clinical trials: Rotavirus Infection
- Condition Rotavirus Infection
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
Infections, Rotavirus
A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
The main objectives of this study are: 1) In a subset (N = 20 000), 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
- NCT00140673
- Testing
- Rotavirus
- Where
- 17 sites in Argentina, Brazil and 10 more
- Volunteers
- 63,227 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in…
- Trial name
- NCT00480324
- Testing
- Rotarix
- Where
- 20 sites in Japan
- Volunteers
- 765 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
- Trial name
- NCT01110044
- Testing
- 251154 vaccine, Infanrix hexa™, Synflorix™
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
Rotavirus Infections, Gastroenteritis
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.
- Trial name
- NCT00130832
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Oral Poliovirus Vaccine (OPV), Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
- Volunteers
- 735 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Rotavirus
Special Drug Use Investigation for ROTARIX®
This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.
- Trial name
- NCT01636739
- Testing
- Oral Rotarix®, Data collection
- Volunteers
- 10,982 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously…
- Trial name
- NCT00729001
- Testing
- Human Rotavirus Vaccine - two different formulations, Prevnar, IPOL
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Study of Immunogenicity & Safety of 2 Different Formulations of 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
- NCT00137930
- Testing
- Live attenuated rotavirus vaccine
- Where
- 5 sites in Finland
- Volunteers
- 250 people, healthy volunteers welcome
- 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 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
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
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
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
Infections, Rotavirus
Drug Use Investigation for ROTARIX®
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
- Trial name
- NCT01636193
- Testing
- Oral Rotarix®, Data collection
- Volunteers
- 1,607 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants
To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
- Trial name
- NCT00425737
- Testing
- Rotarix
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy adults aged 18 to 45 years in China.
- Trial name
- NCT01162590
- Testing
- Rotarix ™
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline