Clinical trials: Rotavirus Vaccines
Infections, Rotavirus
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
- Trial name
- NCT00140686
- Testing
- Rotavirus (vaccine)
- Where
- 101 sites in Czechia, Finland and 4 more
- Volunteers
- 3,994 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infections
Consistency Lots Vaccine Study (V260-009)
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
- Trial name
- NCT00092456
- Testing
- rotavirus vaccine, live, oral, pentavalent
- Volunteers
- 793 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Rotavirus
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV…
- Trial name
- NCT00382772
- Testing
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Where
- 12 sites in Finland
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
- Trial name
- NCT00383903
- Testing
- HRV vaccine
- Where
- 6 sites in South Africa
- Volunteers
- 472 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Infections, Rotavirus
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants.
- Trial name
- NCT00263666
- Testing
- Rotarix, Tritanrix-HB+Hib, Polio Sabin
- Where
- 6 sites in South Africa
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City (administrative district), Japan, where RV vaccines have been introduced since November 2011 and financial support for vaccination costs by…
- Trial name
- NCT01733862
- Testing
- Data collection
- Where
- 7 sites in Japan
- Volunteers
- 5,394 people
- 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
Rotavirus Gastroenteritis
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants 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
- NCT04596696
- Testing
- Rotavac
- Where
- Vietnam
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
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
Rotavirus Gastroenteritis, Diphtheria
A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.
- Conditions
- Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01003431
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP), Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Rotavirus
Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.
- Trial name
- NCT01171963
- Testing
- GSK Biologicals' liquid human rotavirus vaccine 444563, Infanrix™, Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
- Where
- 4 sites in China
- Volunteers
- 3,340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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 Efficacy and Safety Trial (REST)(V260-006)
This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.
- Trial name
- NCT00090233
- Testing
- Rotateq™
- Volunteers
- 69,274 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus
Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants
The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix…
- Trial name
- NCT02907216
- Testing
- Squarekids, Rotarix
- Where
- 11 sites in Japan
- Volunteers
- 292 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
Hepatitis B
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose…
- Trial name
- NCT00158756
- Testing
- Tritanrix™-HepB, Rotarix™, Zilbrix™
- Where
- 9 sites in Russia
- Volunteers
- 308 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
- Trial name
- NCT01177826
- Testing
- Sample collection
- Where
- 29 sites in Belgium
- Volunteers
- 643 people
- Sponsor
- GlaxoSmithKline
Rotavirus Disease
Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants.
- Trial name
- NCT01926015
- Testing
- RotaTeq™ (V260), DTP-IPV
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC