NCT03020628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

January 11, 2017

Last Update Submit

October 31, 2017

Conditions

Influenza, Human

Keywords

Influenza VaccinesVaccines, InactivatedCell Culture-Derived

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

NBP607-QIV 0.5mL

EXPERIMENTAL

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Biological: NBP607-QIV

NBP607-TIV 0.25mL

ACTIVE COMPARATOR

Trivalent Inactivated Cell Culture-derived Influenza Vaccine

Biological: NBP607-TIV

Interventions

NBP607-QIVBIOLOGICAL

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-QIV 0.5mL
NBP607-TIVBIOLOGICAL

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

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Korea University ANSAN hospital

Ansan, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Gachon University Gil Medical center

Incheon, South Korea

Location

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

Incheon, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Eulji General Hospital

Seoul, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Seoul, South Korea

Location

Korea Institute of Radiological and Medical Science

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Yun Kyung Kim

    Korea University Ansan Hospital

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(12)