Clinical trials: Rotavirus Vaccines
Rotavirus Gastroenteritis
Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
- Trial name
- NCT02584816
- Testing
- BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV, BRV-PV Lot C + DPT-HepB-Hib + OPV
- Where
- 10 sites in India
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Viral Gastroenteritis Due to Rotavirus
A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E
The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe rotavirus gastroenteritis, in comparison…
- Trial name
- ROTAVAC (NCT01305109)
- Testing
- ORV 116E
- Where
- 3 sites in India
- Volunteers
- 6,800 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Rotavirus Infection
The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines
This study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization…
- Trial name
- ERVS (NCT02662543)
- Where
- Estonia
- Volunteers
- 2,260 people
- Sponsor
- University of Tartu
Safety Issues
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
- Trial name
- NCT03462108
- Testing
- Rotavirus (Bio Farma) Vaccine
- Where
- 4 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
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
Healthy
A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of Age Immunization Schedule
The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an…
- Trial name
- NCT03566940
- Testing
- sIPV, cIPV
- Where
- 3 sites in Philippines
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Diarrhea, Diarrhea Rotavirus
Phase III Study of Liquid Formulation of ROTAVIN
This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second…
- Trial name
- NCT03703336
- Testing
- ROTAVIN (liquid formulation), ROTAVIN-M1 (frozen formulation)
- Where
- 2 sites in Vietnam
- Volunteers
- 825 people, healthy volunteers welcome
- Sponsor
- Center for Research and Production of Vaccines and Biologicals, Vietnam
Rotavirus Vaccines
Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine
Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination.
- Trial name
- NCT03804489
- Testing
- Decision aids
- Where
- Taiwan
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Diarrhea, Gastroenteritis
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months).
- Trial name
- NCT01960725
- Testing
- RV5 (Pentavalent Rotavirus Vaccine)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dennis Clements
Measles Antibody Seroconversion, Rubella Antibody Seroconversion
Coadministration of Measles-rubella and Rotavirus Vaccines
The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates.
- Conditions
- Measles Antibody Seroconversion, Rubella Antibody Seroconversion, Rotavirus Geometric Mean Titer (GMT), Rotavirus Immunoglobulin A (IgA) Seropositivity
- Trial name
- NCT01700621
- Testing
- Rotarix vaccine, measles-rubella vaccine
- Where
- Bangladesh
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PATH
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 Vaccine
Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine
The study will evaluate safety and immunogenicity of LORV (Rotarix and RV3-BB) when TV P2-VP8, a parentally administered rotavirus vaccine is administered either concomitantly or as a prime/boost model.
- Trial name
- NCT04344054
- Testing
- RV3-BB, Trivalent P2-VP8, Rotarix
- Where
- 2 sites in South Africa
- Volunteers
- 850 people, healthy volunteers welcome
- Sponsor
- PATH
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
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
Randomized, Double-blind
Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.
- Conditions
- Randomized, Double-blind, Placebo Control Design
- Trial name
- NCT01738074
- Testing
- trivalent rotavirus genetic reassortment vaccine
- Volunteers
- 10,020 people, healthy volunteers welcome
- Sponsor
- Center for Disease Control and Prevention, Henan Province
Healthy Volunteers
Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
- Trial name
- NCT06350058
- Testing
- Inactivated rotavirus vaccine (low dose), Inactivated rotavirus vaccine (high dose)
- Where
- China
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Rotavirus Gastroenteritis
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners.
- Trial name
- IVANHOE (NCT00740935)
- Testing
- Rotateq vaccine
- Where
- France
- Volunteers
- 7,204 people
- Sponsor
- University Hospital, Brest