NCT03020628

Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children Aged 6~35 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6\~35 months.

Detailed description

Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	NBP607-QIV	For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]
BIOLOGICAL	NBP607-TIV	For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-01
• Completion: 2017-06-01
• First posted: 2017-01-13
• Last updated: 2017-11-01

Locations

12 sites across 1 country: South Korea