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

Phase 3

Completed

• Conditions: Influenza, Human
• Interventions: Biological: NBP607-QIV; Biological: NBP607-TIV

• Registration Number: NCT03020628
• Lead Sponsor: SK Chemicals Co., Ltd.

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Primary Completion: 2017-03
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBP607-QIV 0.5mL	NBP607-QIV	Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine
NBP607-TIV 0.25mL	NBP607-TIV	Trivalent Inactivated Cell Culture-derived Influenza Vaccine

Primary Outcome Measures

Name	Time	Method
HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%	At Day 28 post-vaccination	Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40
HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%	At Day 28 post-vaccination	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
HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5	At Day 28 post-vaccination	GMR \[geometric mean ratio, mean fold increase\]

Trial Locations

Locations (12)

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Korea, Republic of

The Catholic University of Korea, Incheon ST. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of

Gachon University Gil Medical center; 🇰🇷 Incheon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Korea University ANSAN hospital; 🇰🇷 Ansan, Korea, Republic of

Hallym University Dongtan Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Eulji General Hospital; 🇰🇷 Seoul, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Korea Institute of Radiological and Medical Science; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of