Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

Phase 3

Completed

• Conditions: Influenza, Human
• Interventions: Biological: NBP607-QIV; Biological: Agrippal S1

• Registration Number: NCT02621164
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Study First Submitted: 2015-11-30
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Study First Posted: 2015-12-03
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBP607-QIV	NBP607-QIV	Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine
Agrippal S1	Agrippal S1	Trivalent Inactivated Egg-derived Influenza Vaccine

Primary Outcome Measures

Name	Time	Method
CHMP criteria	At Day 28 post-vaccination	Seroprotection rate \> 70%, Seroconversion rate \> 40%, GMR \> 2.5

Secondary Outcome Measures

Name	Time	Method
Incidence rate of Advers Event (AE)	During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE	Including Solicited Local AE, Solicited Systemic AE, and 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
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
Physical Examination	At Day 0 and at Day 28 post-vaccination