Influenza Clinical Trial
Official title:
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. Part 1 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),
study subjects eligible for participating this trial protocol were assigned to test
group and receiving the test drug 1 times or 2 times according to age.
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
Status | Completed |
Enrollment | 543 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 19 Years |
Eligibility |
Inclusion Criteria: 1. Healthy infants and adolescents aged 6 month to 19 years 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: 1. Those with a history of allergic reaction to eggs or chicken, the vaccine components 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Changwon Fatima Hospital | Changwon | |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | The Catholic Univ. of Korea Daejeon St. Mary's Hospital | Daejeon | |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Inha University Hospital | Incheon | |
Korea, Republic of | Chonbuk National University Hospital | Jeonju | |
Korea, Republic of | Eulji University Medical Center | Seoul | |
Korea, Republic of | Kepco Medical Center | Seoul | |
Korea, Republic of | Korea Cancer Center Hospital | Seoul | |
Korea, Republic of | The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | |
Korea, Republic of | The Catholic Univ. of Korea St. Vincent's Hospital | Suwon | |
Korea, Republic of | Wonju Severance Christian Hospital | Wonju |
Lead Sponsor | Collaborator |
---|---|
Green Cross Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | SAEs (VIsit 1 to Day 180) | The presence of the serious adverse events occurred from visit 1 to day 180 | VIsit 1 (Day 0) to Day 180 | Yes |
Primary | 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) | No |
Secondary | GMT | GMT (Geometric Mean Titer) of HI antibody titer before vaccination (Day 0) and after vaccination (Day 28) | Post-vaccination (Day 28) | No |
Secondary | GMR | GMR (Geometric Mean Ratio) of HI antibody titer before vaccination (Day 0) and after vaccination (Day 28) | Post-vaccination (Day 28) | No |
Secondary | The solicited adverse events (7 days after vaccination) | The presence of the solicited adverse events occurred during 7 days after vaccination Local reaction: pain, tenderness, erythema/redness, induration/swelling Systemic reaction: fever, sweating, chills, nausea/vomiting, diarrhea, fatigue/malaise, headache, myalgia, arthralgia | Post-vaccination (Day 7) | Yes |
Secondary | The unsolicited adverse events (28 days after vaccination) | The presence of the unsolicited adverse events occurred during 28 days after the study vaccination | Post-vaccination (Day 28) | Yes |
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