Bivalent Norovirus Vaccine Study

Status Completed

Clinical Trial Summary

Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by IM injection, 28 days apart.

The hypotheses for this study are:

- The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and Al(OH)3.

- Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.

- The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Gastroenteritis

Clinical Trial Details

NCT number	NCT01168401
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 1
Start date	September 3, 2010
Completion date	January 9, 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02541695` - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli	N/A
Completed	`NCT02473887` - Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting	Phase 1
Completed	`NCT01911143` - A Retrospective, Blinded Validation of a Host-response Based Diagnostics	N/A
Not yet recruiting	`NCT01671137` - Probiotic for the Prevention of Functional Disorders in Childhood	N/A
Completed	`NCT01917461` - Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections	N/A
Withdrawn	`NCT00691275` - Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration	N/A
Recruiting	`NCT06025695` - Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks	Phase 3
Completed	`NCT04463082` - Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound	N/A
Completed	`NCT02497417` - A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients	N/A
Active, not recruiting	`NCT03000296` - Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease	N/A
Completed	`NCT01236066` - Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia	N/A
Completed	`NCT01225042` - The Effect of Probiotics on E. Coli Gastroenteritis	N/A
Recruiting	`NCT00987519` - Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age	N/A
Terminated	`NCT01357174` - ROTATEQ™ Post-Marketing Surveillance in the Philippines	N/A
Completed	`NCT01033799` - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers	N/A
Recruiting	`NCT01363726` - Surveillance of Rotavirus Gastroenteritis in Children <5 Years	N/A
Completed	`NCT00130832` - Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)	Phase 3
Terminated	`NCT02568189` - Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration	N/A
Terminated	`NCT02165813` - Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children	Phase 2/Phase 3
Completed	`NCT01853124` - Emergency Department Probiotic Treatment of Pediatric Gastroenteritis	Phase 3