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Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

NBP607-QIV

Agrippal S1

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NBP607-QIV

Agrippal S1

Arm Description

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Trivalent Inactivated Egg-derived Influenza Vaccine

Outcomes

Primary Outcome Measures

CHMP criteria

Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5

Secondary Outcome Measures

Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80

Immunogenicity compared to control group

Incidence rate of Advers Event (AE)

Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE

Incidence rate of Severe Adverse Event (SAE)

Vital Sign

Physical Examination

Full Information

NCT ID

NCT02621164

First Posted

November 30, 2015

Last Updated

December 1, 2015

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02621164

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

June 2015 (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 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.

6. Conditions and Keywords

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

Influenza, Human

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

454 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NBP607-QIV

Arm Type

Experimental

Arm Description

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Arm Title

Agrippal S1

Arm Type

Active Comparator

Arm Description

Trivalent Inactivated Egg-derived Influenza Vaccine

Intervention Type

Biological

Intervention Name(s)

NBP607-QIV

Intervention Description

For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

Intervention Type

Biological

Intervention Name(s)

Agrippal S1

Intervention Description

For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

Primary Outcome Measure Information:

Title

CHMP criteria

Description

Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5

Time Frame

At Day 28 post-vaccination

Secondary Outcome Measure Information:

Title

Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80

Time Frame

At Day 28 post-vaccination

Title

Immunogenicity compared to control group

Time Frame

At Day 28 post-vaccination

Title

Incidence rate of Advers Event (AE)

Description

Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE

Time Frame

During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE

Title

Incidence rate of Severe Adverse Event (SAE)

Time Frame

During 6 months post-vaccination

Title

Vital Sign

Time Frame

At Day 0 and at Day 28 post-vaccination

Title

Physical Examination

Time Frame

At Day 0 and at Day 28 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: