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

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Agrippal S1; Biological: NBP607-QIV

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.

• Study Type: Interventional
• Enrollment (Actual): 454
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children and adolescents aged 6 months to 18 years.
• Those who was born after normal pregnancy period(37 weeks) for aged 6 months to < 1 year
• Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.

Exclusion Criteria:

• Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
• Subjects with immune deficiency disorder or malignant cancer.
• History of Guillain-Barre syndrome.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day.
• Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
• Subjects who had received blood products or immunoglobulin within 3 months before screening.
• Subjects who had received influenza vaccination within 6 months prior to the screening.
• Subjects who had received other vaccination within a month before. screening, or those who had another vaccination scheduled within a month after study vaccination.
• Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
• Subjects with clinically significant chronic disease.
• Pregnant women, breast-feeding women.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Agrippal S1; Trivalent Inactivated Egg-derived Influenza Vaccine	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)
Experimental: NBP607-QIV; Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHMP criteria	Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5	At Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80		At Day 28 post-vaccination
Immunogenicity compared to control group		At Day 28 post-vaccination
Incidence rate of Advers Event (AE)	Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE	During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE
Incidence rate of Severe Adverse Event (SAE)		During 6 months post-vaccination
Vital Sign		At Day 0 and at Day 28 post-vaccination
Physical Examination		At Day 0 and at Day 28 post-vaccination

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Study Chair: Yun Kyung Kim, Korea University Ansan Hospital; Principal Investigator: Byung Wook Eun, Eulji General Hospital; Principal Investigator: Jina Lee, Asan Medical Center; Principal Investigator: Dong Ho Kim, Korea Institute of Radiological and Medical Science; Principal Investigator: Dae Sun Jo, Chonbuk National University Hospital; Principal Investigator: Seon Hee Shin, Hallym University Dongtan Sacred Heart Hospital; Principal Investigator: Taek Jin Lee, CHA University; Principal Investigator: Ki Hwan Kim, Severance Children's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: NBP607-QIV_FluC_III_2014