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

NCT ID: NCT03020628

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Influenza, Human

Keywords

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Influenza Vaccines Vaccines, Inactivated Cell Culture-Derived

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NBP607-QIV 0.5mL

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Group Type EXPERIMENTAL

NBP607-QIV

Intervention Type BIOLOGICAL

For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]

NBP607-TIV 0.25mL

Trivalent Inactivated Cell Culture-derived Influenza Vaccine

Group Type ACTIVE_COMPARATOR

NBP607-TIV

Intervention Type BIOLOGICAL

For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]

Interventions

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NBP607-QIV

For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]

Intervention Type BIOLOGICAL

NBP607-TIV

For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun Kyung Kim

Role: STUDY_CHAIR

Korea University Ansan Hospital

Hye Kyung Cho

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Ki Hwan Kim

Role: PRINCIPAL_INVESTIGATOR

Incheon St.Mary's Hospital

Byung Wook Eun

Role: PRINCIPAL_INVESTIGATOR

Eulji General Hospital

Yae Jean Kim

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Jina Lee

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Dong Ho Kim

Role: PRINCIPAL_INVESTIGATOR

Korea Institute of Radiological and Medical Science

Hwang Min Kim

Role: PRINCIPAL_INVESTIGATOR

Wonju Severance Christian Hospital

Nam Hee Kim

Role: PRINCIPAL_INVESTIGATOR

Inje University Ilsan Paik Hospital

Dae Sun Jo

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Eun Young Cho

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Seon Hee Shin

Role: PRINCIPAL_INVESTIGATOR

Hallym University Dongtan Sacred Heart Hospital

Locations

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Korea University ANSAN hospital

Ansan, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Goyang, , South Korea

Site Status

Gachon University Gil Medical center

Incheon, , South Korea

Site Status

The Catholic University of Korea, Incheon ST. Mary's Hospital

Incheon, , South Korea

Site Status

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Eulji General Hospital

Seoul, , South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital

Seoul, , South Korea

Site Status

Korea Institute of Radiological and Medical Science

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NBP607-QIV_FluC_III_2016

Identifier Type: -

Identifier Source: org_study_id