NCT02153112 - Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children | Biotech Hunter

Enrollment

840

Participants

Timeline

Start Date

June 23, 2015

Primary Completion Date

June 20, 2018

Study Completion Date

June 20, 2018

Conditions

Norovirus

Interventions

BIOLOGICAL

GI.1/GII.4 (15/15)

Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

BIOLOGICAL

GI.1/GII.4 (15/50)

Norovirus GI.1/GII.4 (15 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

BIOLOGICAL

GI.1/GII.4 (50/50)

Norovirus GI.1/GII.4 (50 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

BIOLOGICAL

GI.1/GII.4 (50/150)

Norovirus GI.1/GII.4 (50 μg/150 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

DRUG

Placebo

Placebo saline solution

Trial Locations (12)

2230

Espoon Rokotetutkimusklinikka, Espoo

20520

Turun Rokotetutkimusklinikka, Turku

28100

Porin Rokotetutkimusklinikka, Pori

33100

Oulun Rokotetutkimusklinikka, Oulu

Tampere Vaccine Research Clinic, Tampere

60100

Seinajoen Rokotetutkimusklinikka, Seinäjoki

90220

Ita-Helsingin Rokotetutkimusklinikka, Helsinki

Unknown

Centro de Estudios em Infectologia Pediatrica SAS, Santiago de Cali

CEVAXIN Plaza Carolina - Ciudad de Panama, Panama City

CEVAXIN, Panama City

00100

Etela-Helsingin Rokotetutkimusklinikka, Helsinki

04400

Jarvenpaan Rokotetutkimusklinikka, Jarvenpaan