NCT02621164

Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

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 and Adolescents Aged 6 Months ~ 18 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Accepted

Summary

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Detailed description

Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. 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 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
BIOLOGICAL	Agrippal S1	For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-02-01
• Completion: 2015-06-01
• First posted: 2015-12-03
• Last updated: 2015-12-03