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

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

NBP607-QIV

NBP607-TIV

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza Vaccines, Vaccines, Inactivated, Cell Culture-Derived

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Korea University ANSAN hospital
Chungnam National University Hospital
Inje University Ilsan Paik Hospital
Gachon University Gil Medical center
The Catholic University of Korea, Incheon ST. Mary's Hospital
Chonbuk National University Hospital
Asan Medical Center
Eulji General Hospital
Hallym University Dongtan Sacred Heart Hospital
Korea Institute of Radiological and Medical Science
Samsung Medical Center
Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NBP607-QIV 0.5mL

NBP607-TIV 0.25mL

Arm Description

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Trivalent Inactivated Cell Culture-derived Influenza Vaccine

Outcomes

Primary Outcome Measures

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

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

HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5

GMR [geometric mean ratio, mean fold increase]

Secondary Outcome Measures

Full Information

NCT ID

NCT03020628

First Posted

January 11, 2017

Last Updated

October 31, 2017

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03020628

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human

Keywords

Influenza Vaccines, Vaccines, Inactivated, Cell Culture-Derived

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

171 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NBP607-QIV 0.5mL

Arm Type

Experimental

Arm Description

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Arm Title

NBP607-TIV 0.25mL

Arm Type

Active Comparator

Arm Description

Trivalent Inactivated Cell Culture-derived Influenza Vaccine

Intervention Type

Biological

Intervention Name(s)

NBP607-QIV

Intervention Description

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]

Intervention Type

Biological

Intervention Name(s)

NBP607-TIV

Intervention Description

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]

Primary Outcome Measure Information:

Title

HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%

Description

Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40

Time Frame

At Day 28 post-vaccination

Title

HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%

Description

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

Time Frame

At Day 28 post-vaccination

Title

HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5

Description

GMR [geometric mean ratio, mean fold increase]

Time Frame

At Day 28 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Accepts Healthy Volunteers

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.

Overall Study Officials: