Clinical trial NCT03020628: Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months
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 Aged 6~35 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Influenza Vaccines
Vaccines, Inactivated
Cell Culture-Derived
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 171
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
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 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%
timeFrame: At Day 28 post-vaccination
measure: HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%
timeFrame: At Day 28 post-vaccination
measure: HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5
timeFrame: At Day 28 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University ANSAN hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical center
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon ST. Mary's Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Institute of Radiological and Medical Science
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Korea University Ansan Hospital
name: Yun Kyung Kim
role: STUDY_CHAIR
affiliation: Gachon University Gil Medical Center
name: Hye Kyung Cho
role: PRINCIPAL_INVESTIGATOR
affiliation: Incheon St.Mary's Hospital
name: Ki Hwan Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji General Hospital
name: Byung Wook Eun
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Yae Jean Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Jina Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea Institute of Radiological and Medical Science
name: Dong Ho Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Severance Christian Hospital
name: Hwang Min Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Ilsan Paik Hospital
name: Nam Hee Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Dae Sun Jo
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Eun Young Cho
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Dongtan Sacred Heart Hospital
name: Seon Hee Shin
role: PRINCIPAL_INVESTIGATOR
References: