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

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

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.

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.

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.