Clinical trial NCT02621164: Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
Official title: 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 and Adolescents Aged 6 Months ~ 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-03
Enrollment: 454
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: CHMP criteria
timeFrame: At Day 28 post-vaccination
Secondary outcomes:
measure: Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80
timeFrame: At Day 28 post-vaccination
measure: Immunogenicity compared to control group
timeFrame: At Day 28 post-vaccination
measure: Incidence rate of Advers Event (AE)
timeFrame: During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE
measure: Incidence rate of Severe Adverse Event (SAE)
timeFrame: During 6 months post-vaccination
measure: Vital Sign
timeFrame: At Day 0 and at Day 28 post-vaccination
measure: Physical Examination
timeFrame: At Day 0 and at Day 28 post-vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Ansan Hospital
name: Yun Kyung Kim
role: STUDY_CHAIR
affiliation: Eulji General Hospital
name: Byung Wook Eun
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA University
name: Taek Jin Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Jina Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Children's Hospital
name: Ki Hwan Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea Institute of Radiological and Medical Science
name: Dong Ho Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Dae Sun Jo
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Dongtan Sacred Heart Hospital
name: Seon Hee Shin
role: PRINCIPAL_INVESTIGATOR
References: