Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

NCT ID: NCT02621164

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 454 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-06-30

Brief Summary

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

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.

Conditions

Influenza, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

NBP607-QIV

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Group Type: EXPERIMENTAL

NBP607-QIV

Intervention Type: BIOLOGICAL

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)

Agrippal S1

Trivalent Inactivated Egg-derived Influenza Vaccine

Group Type: ACTIVE_COMPARATOR

Agrippal S1

Intervention Type: BIOLOGICAL

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)

Interventions

NBP607-QIV

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)

Intervention Type: BIOLOGICAL

Agrippal S1

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)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun Kyung Kim

Role: STUDY_CHAIR

Korea University Ansan Hospital

Byung Wook Eun

Role: PRINCIPAL_INVESTIGATOR

Eulji General Hospital

Taek Jin Lee

Role: PRINCIPAL_INVESTIGATOR

CHA University

Jina Lee

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Ki Hwan Kim

Role: PRINCIPAL_INVESTIGATOR

Severance Children's Hospital

Dong Ho Kim

Role: PRINCIPAL_INVESTIGATOR

Korea Institute of Radiological and Medical Science

Dae Sun Jo

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Seon Hee Shin

Role: PRINCIPAL_INVESTIGATOR

Hallym University Dongtan Sacred Heart Hospital

Other Identifiers

NBP607-QIV_FluC_III_2014

Identifier Type: -

Identifier Source: org_study_id