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

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 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
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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.

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 Aged 6 35 Months

Conditions
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Influenza, Human

Intervention / Treatment
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* Biological: NBP607-QIV
* Biological: NBP607-TIV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 6 months to 35 months 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 with immune deficiency disorder or malignant cancer. History of any hypersensitivity following administration of vaccine or 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 received any other investigational products within 4 weeks prior to study vaccination. Subjects with clinically significant chronic disease. 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: 35 Months

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 0.5mL<br>Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine | Biological: NBP607-QIV<br>* 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]<br>|
| Active Comparator: NBP607-TIV 0.25mL<br>Trivalent Inactivated Cell Culture-derived Influenza Vaccine | Biological: NBP607-TIV<br>* 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]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70% | Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40 | At Day 28 post-vaccination | 
| HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40% | Seroconversion is defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer | At Day 28 post-vaccination | 
| HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5 | GMR [geometric mean ratio, mean fold increase] | At Day 28 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza Vaccines, Vaccines, Inactivated, Cell Culture-Derived