A Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children
An Open-label(Part1), Single Arm(Part1), Randomized(Part2), Double-blind(Part2), Active-controlled(Part2), Phase III Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children
1 other identifier
interventional
543
1 country
12
Brief Summary
- 6 m \~ 3 years
- 3 years \~ 9 years
- 9 years \~ 19 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Shorter than P25 for phase_3
12 active sites
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
First Submitted
Initial submission to the registry
August 28, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 7, 2016
November 1, 2016
9 months
August 28, 2015
November 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage of study subjects achieving seroconversion* for HI antibody(seroconversion rate) The percentage of study subjects achieving a post-vaccination HI antibody titer≥1:40 (seroprotection rate)
the percentage of study subjects with a pre-vaccination (Day 0) HI titer\<1:10 and post-vaccination (Day 28) HI antibody titer≥1:40(Case1), or the percentage of study subjects with a pre-vaccination HI antibody titer≥1:10 and a minimum four-fold rise in post-vaccination HI antibody titer(Case 2)
Post-vaccination (Day 28)
Secondary Outcomes (4)
GMT
Post-vaccination (Day 28)
GMR
Post-vaccination (Day 28)
The solicited adverse events (7 days after vaccination)
Post-vaccination (Day 7)
The unsolicited adverse events (28 days after vaccination)
Post-vaccination (Day 28)
Other Outcomes (1)
SAEs (VIsit 1 to Day 180)
VIsit 1 (Day 0) to Day 180
Study Arms (2)
GC3110A
EXPERIMENTALOne injection : 0.5ml or 0.25ml, IM on day 0 Two injection : 0.5ml or 0.25ml, IM on day 0
GCFLU Pre-filled Syringe inj.
ACTIVE COMPARATOROne injection : 0.5ml or 0.25ml, IM on day 0 Two injection : 0.5ml or 0.25ml, IM on day 0
Interventions
A single 0.5mL dose intramuscular injection
Eligibility Criteria
You may qualify if:
- Healthy infants and adolescents aged 6 month to 19 years
- study Subject was born at full term pregnancy(37 weeks)
- study Subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form (less than 7 years of age, written informed consent by study subject's legal guardians)
You may not qualify if:
- Those with a history of allergic reaction to eggs or chicken, the vaccine components
- Those who had been ad ministered the influenza vaccine 6 months prior to the study drug vaccination
- Those with immunologic impairment including immune deficiency disorders or family history about it.
- Those with a history of Guillain-Barre syndrome
- Those with a history of Down's syndrome or cytogenetic disorders
- Those who would be ineligible to participate the study as follows: serious chronic disease (cardiovascular system disease; excluding controlled hypertension and respiratory system disease; including respiratory failure, metabolic disease, renal dysfunction, hemoglobinopathy, etc)
- Hemophilia patients at risk of serious bleeding with intramuscular injection or those receiving anticoagulant therapy
- Those who have active infection or who have fever higher than 38.0℃ within 72 hours prior to the dosing of study drug
- Those who had been vaccinated with another vaccine within 28 days prior to the dosing of study drug or had a scheduled vaccination during the clinical trial period
- Those who had received an immunosuppressant, immunity-modifying drug within 3 months prior to the dosing of study drug - (1) Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc., (2) Those receiving high dose of corticosteroid(15mg/day of prednisolone is acceptable, but study subject used consistently 2mg/kg more than 14days is considered a high dose, so excluded in this clinical trial. However, inhalated, intra nasal and topical administration is acceptable regardless of dose.
- Those who had received immunoglobulin or a blood-derived product within 3 months prior to the dosing of study drug or is scheduled to receive those products during the study period
- Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4 hours prior to the dosing of study drug
- study Subject who had participated in other clinical trial within 28 days prior to the study vaccination
- Those whose clinically significant medical or psychiatric condition at the discretion of the investigator that would be ineligible to participate the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Changwon Fatima Hospital
Changwon, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
The Catholic Univ. of Korea Daejeon St. Mary's Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Inha University Hospital
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Eulji University Medical Center
Seoul, South Korea
Kepco Medical Center
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic Univ. of Korea St. Vincent's Hospital
Suwon, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Related Publications (1)
Lee J, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Hong YJ, Choi YY, Jo DS, Ma SH, Kang JH. Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study. J Korean Med Sci. 2018 Mar 26;33(13):e100. doi: 10.3346/jkms.2018.33.e100.
PMID: 29573247DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-han Kang, Dr.
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2015
First Posted
September 4, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
November 7, 2016
Record last verified: 2016-11