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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: NBP607-QIV; Biological: NBP607-TIV

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Korea University Ansan Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Goyang, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Incheon, Korea, Republic of
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Hallym University Dongtan Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Korea Institute of Radiological and Medical Science
  • Wonju, Korea, Republic of
    • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NBP607-QIV 0.5mL; Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine	Biological: NBP607-QIV; For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]
Active Comparator: NBP607-TIV 0.25mL; Trivalent Inactivated Cell Culture-derived Influenza Vaccine	Biological: NBP607-TIV; For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%	Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40	At Day 28 post-vaccination
HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%	Seroconversion is defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer	At Day 28 post-vaccination
HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5	GMR [geometric mean ratio, mean fold increase]	At Day 28 post-vaccination

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Study Chair: Yun Kyung Kim, Korea University Ansan Hospital; Principal Investigator: Hye Kyung Cho, Gachon University Gil Medical Center; Principal Investigator: Ki Hwan Kim, Incheon St.Mary's Hospital; Principal Investigator: Byung Wook Eun, Eulji General Hospital; Principal Investigator: Yae Jean Kim, Samsung Medical Center; Principal Investigator: Jina Lee, Asan Medical Center; Principal Investigator: Dong Ho Kim, Korea Institute of Radiological and Medical Science; Principal Investigator: Hwang Min Kim, Wonju Severance Christian Hospital; Principal Investigator: Nam Hee Kim, Inje University Ilsan Paik Hospital; Principal Investigator: Dae Sun Jo, Chonbuk National University Hospital; Principal Investigator: Eun Young Cho, Chungnam National University Hospital; Principal Investigator: Seon Hee Shin, Hallym University Dongtan Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Influenza Vaccines; Vaccines, Inactivated; Cell Culture-Derived
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: NBP607-QIV_FluC_III_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO