Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

SK chemicals

Status and phase

Completed

Phase 3

Conditions

Influenza, Human

Treatments

Biological: Agrippal S1

Biological: NBP607-QIV

Study type

Interventional

Funder types

Industry

Identifiers

NCT02621164

NBP607-QIV_FluC_III_2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

454 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

Accepts Healthy Volunteers

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.