Clinical trials: Rotavirus Infections
Rotavirus Infection
A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.
- Trial name
- NCT01764256
- Testing
- P2-VP8 subunit rotavirus vaccine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- PATH
Intussusception, Rotavirus Infections
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses.
- Trial name
- NCT02542462
- Testing
- Rotarix®,, Rotarix®, with other routine vaccines, RotaTeq®,
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
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
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
Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries.
- Conditions
- Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine, Shedding of Oral Rotavirus Vaccine
- Trial name
- NCT01616693
- Testing
- Probiotic, Zinc, Rotavirus vaccine
- Where
- India
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- PATH
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
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
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
Rotavirus Infections, Gastroenteritis
Vaccine Effectiveness of RV1 in a Naïve Population
Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would amount to 13,600 Canadian children < 5 years.
- Conditions
- Rotavirus Infections, Gastroenteritis, Diarrhea
- Trial name
- NCT01467037
- Testing
- No intervention done
- Where
- 3 sites in Canada
- Volunteers
- 374 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Rotavirus Disease
V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)
The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.
- Trial name
- NCT00258154
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Infanrix(tm) Hexa
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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 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
HIV Infection, Rotavirus Infection
Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries.
- Trial name
- NCT00880698
- Testing
- RotaTeq
- Where
- 6 sites in Botswana, Tanzania and 2 more
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Infections
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.
- Trial name
- NCT03483116
- Testing
- RV3-BB
- Where
- Malawi
- Volunteers
- 711 people, healthy volunteers welcome
- Sponsor
- Murdoch Childrens Research Institute
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
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 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