Clinical trials: Rotavirus Vaccine
Rotavirus Infection of Children
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
- Trial name
- Rota5DCHILE (NCT06200844)
- Testing
- ROTAVAC 5D
- Where
- 16 sites in Chile
- Volunteers
- 5,800 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
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
Hepatitis B
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
- Trial name
- NCT00429481
- Testing
- Rotarix
- Volunteers
- 2,464 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Innate Immune Response
Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.
- Trial name
- PPIR (NCT01700127)
- Testing
- Breastfeeding
- Where
- India
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Society for Applied Studies
Rotavirus Infection, Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in…
- Trial name
- NCT01511133
- Testing
- Stool sample, Serum sample
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Rotavirus Infections, Rotavirus Vaccines
Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.
The purpose of the presented study was to evaluate the safety and immunological efficacy in preventing the rotavirus infection within a cohort of healthy subjects (target age of 18-45 years old) by using the pentavalent rotavirus…
- Trial name
- NCT05037435
- Testing
- The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)
- Where
- Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Limited Liability Company Pharm Aid
Diarrhea
Effectiveness of Rotavirus Immunization in Nicaragua
The purpose of the investigators study is to compare the rates of childhood diarrhea at the community level before and after the rotavirus vaccination program in León, Nicaragua.
- Trial name
- NCT01133808
- Volunteers
- 667 people
- Sponsor
- Sylvia Becker-Dreps
Healthy
Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
A study to investigate the safety and reactogenicity of MT-5625 independently in adults aged 18-35 years, toddlers ages 12-24 months, and infants aged 6-10 weeks
- Trial name
- NCT03507738
- Testing
- MT-5625 low dose, MT-5625 middle dose, MT-5625 high dose
- Where
- 2 sites in Australia, South Africa
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Rotavirus
The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and…
- Trial name
- NCT03031743
- Where
- Pakistan
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rotavirus, Acute Gastroenteritis
Effectiveness of Monovalent Rotavirus Vaccine (RV1)
To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and the Medical University of South Carolina…
- Trial name
- NCT01871038
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Vomiting, Diarrhea
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
- Conditions
- Vomiting, Diarrhea, Fever
- Trial name
- NCT00362648
- Testing
- RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
- Volunteers
- 7,504 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pertussis Immunisation, Diphtheria Immunisation
Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Primary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: To describe the immunogenicity profile…
- Conditions
- Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation, Hepatitis B Immunisation
- Trial name
- NCT04429295
- Testing
- DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus), DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b), Inactivated Poliomyelitis Vaccine
- Where
- 3 sites in Thailand
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rotavirus Infections
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks 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
- NCT03367559
- Testing
- ROTAVAC®
- Where
- Vietnam
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Rotavirus Infection
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight…
- Trial name
- NCT01266850
- Testing
- Rotarix®, RotaTeq®
- Where
- 13 sites in United States
- Volunteers
- 1,384 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Safety and Immunogenicity Study of Trivalent P2-VP8 Subunit Rotavirus Vaccine in Adults, Toddlers and Infants
This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers…
- Trial name
- NCT02646891
- Testing
- Trivalent P2-VP8 Subunit Rotavirus Vaccine
- Where
- 3 sites in South Africa
- Volunteers
- 618 people, healthy volunteers welcome
- Sponsor
- PATH
Rotavirus Gastroenteritis
Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab
The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) to determine the population effectiveness of…
- Trial name
- NCT00737503
- Testing
- Rotavirus Vaccine (ROTARIX)
- Where
- Bangladesh
- Volunteers
- 4,550 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Infections, Rotavirus
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human…
- Trial name
- NCT00329745
- Testing
- Rotarix™
- Where
- 4 sites in Singapore
- Volunteers
- 8,687 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline