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

SK chemicals

Status and phase

Completed

Phase 3

Conditions

Influenza, Human

Treatments

Biological: NBP607-QIV

Biological: NBP607-TIV

Study type

Interventional

Funder types

Industry

Identifiers

NCT03020628

NBP607-QIV_FluC_III_2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment

171 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

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.