Clinical trials: Rotavirus Infections
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
Rotavirus Infections
CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series.
- Trial name
- NCT06485258
- Testing
- 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV), 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Rotavirus Infections, Reaction - Vaccine Nos
Does the Fecal Microbiome Influence Rotarix Immunogenicity
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan.
- Conditions
- Rotavirus Infections, Reaction - Vaccine Nos, Intestinal Bacteria Flora Disturbance
- Trial name
- NCT02220439
- Volunteers
- 76 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or…
- Trial name
- NCT02153333
- Testing
- Serum sample
- Volunteers
- 1 people
- 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
Acute Diarrheal Disease, Rotavirus Infection
Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile
The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from…
- Trial name
- NCT00895492
- Where
- 2 sites in Chile
- Volunteers
- 967 people
- Sponsor
- University of Chile
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
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Background: China's healthcare system for children faces significant challenges, particularly due to the limited pediatric service capacity of primary healthcare institutions.
- Conditions
- Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock, Hand-foot-and-mouth Disease, Acute Appendicitis
- Trial name
- NCT06699433
- Testing
- Virtual standardized patients (VSPs), Case teaching manuals, Case teaching videos
- Where
- 3 sites in China
- Volunteers
- 459 people, healthy volunteers welcome
- Sponsor
- Southern Medical University, China
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
Poliomyelitis, Tropical Enteropathy
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased…
- Trial name
- NCT01571505
- Testing
- IPV vaccination
- Where
- India
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
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
Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease…
- Trial name
- NCT01978223
- Testing
- Stool sample collection
- 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
Diarrhoeal Disease
Development of a Live Attenuated Rotavirus Vaccine as a Human Infection Challenge Model
The impact of licensed rotavirus vaccines in LMICs is limited by their lower immunogenicity and efficacy in these settings. Improved vaccines and vaccination schedules would result in substantially greater reductions in infant…
- Trial name
- NCT04123119
- Testing
- Rotavirus vaccine
- Where
- Zambia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Rotavirus Infections
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) for intradermal administration in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series.
- Trial name
- NCT06962904
- Testing
- 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV), 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
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
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which…
- Trial name
- NCT00653198
- Testing
- No intervention
- Where
- Panama
- Volunteers
- 885 people
- 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