Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Influenza, Human

Intervention / Treatment
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* Biological: NBP607-QIV
* Biological: Agrippal S1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBP607-QIV<br>Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine | Biological: NBP607-QIV<br>* 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)<br>|
| Active Comparator: Agrippal S1<br>Trivalent Inactivated Egg-derived Influenza Vaccine | Biological: Agrippal S1<br>* 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)<br>|

What is the study measuring?
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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 |