Clinical trials: Infections, Rotavirus
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
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
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
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
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan.
- Trial name
- NCT03954743
- Testing
- PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine, Lyophilized formulation of GSK's oral live attenuated HRV vaccine
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 1,351 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis
Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study
This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a…
- Trial name
- fIPV (NCT02847026)
- Testing
- IPV at 14 and 22 weeks of age, Rotarix, IPV at 14 and 22 weeks of age, RotaTeq, IPV at 14 and fIPV at 22 weeks, Rotarix
- Where
- Bangladesh
- Volunteers
- 1,144 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Infections, Rotavirus
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
- Trial name
- NCT00334607
- Testing
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Where
- 42 sites in United States
- Volunteers
- 484 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
Rotavirus Infections, Rotavirus Gastroenteritis
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
- Trial name
- NCT05621655
- Testing
- Mid dose Recombinant Trivalent Subunit Rotavirus Vaccine, High dose Recombinant Trivalent Subunit Rotavirus Vaccine
- Where
- 2 sites in China
- Volunteers
- 1,512 people, healthy volunteers welcome
- Sponsor
- MAXVAX Biotechnology Limited Liability Company
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
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
- Trial name
- NCT00938327
- Testing
- Rotarix™
- Where
- 12 sites in India
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Rotavirus Infections, Environmental Enteric Dysfunction
SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
This is a controlled cohort study to assess the effect of improved sanitation on oral rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique.
- Conditions
- Rotavirus Infections, Environmental Enteric Dysfunction, Enteric Infections
- Trial name
- NCT03313128
- Testing
- Sanitation
- Where
- Mozambique
- Volunteers
- 261 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
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
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
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
Infections, Rotavirus
Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India
Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by…
- Trial name
- NCT00289172
- Testing
- Live attenuated human rotavirus vaccine
- Where
- 4 sites in India
- Volunteers
- 360 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
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