Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children

NCT02153112 PHASE2 COMPLETED Results posted

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for further development in children.

Details

Lead sponsor	Takeda
Phase	PHASE2
Status	COMPLETED
Enrolment	840
Start date	Tue Jun 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jun 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Norovirus

Interventions

• GI.1/GII.4 (15/15)
• GI.1/GII.4 (15/50)
• GI.1/GII.4 (50/50)
• GI.1/GII.4 (50/150)
• Placebo

Countries

Panama, Colombia, Finland