A Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children
NCT ID: NCT02541253
Last Updated: 2016-11-07
Study Results
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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COMPLETED
PHASE3
543 participants
INTERVENTIONAL
2015-09-30
2016-06-30
Brief Summary
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2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2 times according to age as below;
* 6 m \~ 3 years
* 3 years \~ 9 years
* 9 years \~ 19 years
Detailed Description
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The safety data collected during part A will be reviewed by DSMB to evaluate the solicited adverse events for 7 days after each vaccination.
However, if no toxicity higher than grade 3 according to FDA guidance the study was allowed to proceed to Part 2 without DSMB review.
Efficacy and safety assessment methods, and visiting schedule will be the same as Part 2.
2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test drug 1 times or 2 times according to age as below;
* 6 m \~ 3 years
* 3 years \~ 9 years
* 9 years \~ 19 years The investigator will evaluate the efficacy and safety of the test product while clinical trial.
Blood samples will be collected at visit 1 for efficacy evaluation. The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety.
At visit1, blood samples will be collected from randomized study subjects and investigational drug of doses of 0.25mL or 0.5mL according to age will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, aged of over than 6 months to less than 9 years study subjects, will re-visit and have the 2nd vaccination, 4\~5 weeks after the 1st vaccination.
After 4\~5 weeks since last vaccination, study subjects will visit and blood sample will be collected. And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit.
The study subjects with 1 dose of vaccine will have 4 visits including Visit 1\~2 and Visit 5\~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 1\~2, Visit 3\~4 and Visit 5\~6.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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GC3110A
One injection : 0.5ml or 0.25ml, IM on day 0 Two injection : 0.5ml or 0.25ml, IM on day 0
GC3110A
A single 0.5mL dose intramuscular injection
GCFLU Pre-filled Syringe inj.
One 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.
A single 0.5mL dose intramuscular injection
Interventions
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GC3110A
A single 0.5mL dose intramuscular injection
GCFLU Pre-filled Syringe inj.
A single 0.5mL dose intramuscular injection
Eligibility Criteria
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Inclusion Criteria
2. study Subject was born at full term pregnancy(37 weeks)
3. 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)
Exclusion Criteria
2. Those who had been ad ministered the influenza vaccine 6 months prior to the study drug vaccination
3. Those with immunologic impairment including immune deficiency disorders or family history about it.
4. Those with a history of Guillain-Barre syndrome
5. Those with a history of Down's syndrome or cytogenetic disorders
6. 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)
7. Hemophilia patients at risk of serious bleeding with intramuscular injection or those receiving anticoagulant therapy
8. Those who have active infection or who have fever higher than 38.0℃ within 72 hours prior to the dosing of study drug
9. 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
10. 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.
11. 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
12. Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4 hours prior to the dosing of study drug
13. study Subject who had participated in other clinical trial within 28 days prior to the study vaccination
14. Those whose clinically significant medical or psychiatric condition at the discretion of the investigator that would be ineligible to participate the study
6 Months
19 Years
ALL
Yes
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jin-han Kang, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Locations
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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
Countries
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References
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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.
Other Identifiers
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GC3110A_C_P3
Identifier Type: -
Identifier Source: org_study_id