Clinical trials: Rotavirus Vaccines
Infections, Rotavirus
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic drifts (point mutations) in the vaccine…
- Trial name
- NCT01339221
- Testing
- Stool samples
- Where
- 11 sites in Belgium
- Volunteers
- 72 people
- 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
Rotavirus Gastroenteritis
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
- Trial name
- NCT01177657
- Testing
- Stool sampling
- Where
- Brazil
- Volunteers
- 1,944 people
- Sponsor
- GlaxoSmithKline
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
Gastroenteritis, Rotavirus
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
- Trial name
- NCT00496054
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Rotavirus
Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
- Trial name
- NCT01110044
- Testing
- 251154 vaccine, Infanrix hexa™, Synflorix™
- Volunteers
- 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 Gastroenteritis
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines
- Trial name
- NCT04185545
- Testing
- Rotavirus RV3 Vaccine (Bio Farma)
- Where
- 21 sites in Indonesia
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Infections, Rotavirus
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam.
- Trial name
- NCT00345956
- Testing
- Human rotavirus liquid vaccine
- Where
- 2 sites in Vietnam
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
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.
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
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