Influenza Vaccine Clinical Trial
Official title:
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, 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 or control drug 1 time or 2 times.
Status | Not yet recruiting |
Enrollment | 260 |
Est. completion date | August 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 35 Months |
Eligibility |
Inclusion Criteria: 1. Healthy infants aged 6 month to 3 years. 2. Study subject was born at full term pregnancy(37 week) 3. Study subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form 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 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 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | The Catholic Univ.of Korea Seoul St.Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Green Cross Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion rate for HI antibody after final injection | 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 or 56) | |
Primary | Seroprotection rate for HI antibody after final injection | Post-vaccination (Day 28 or 56) | ||
Secondary | GMT | GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28) | Post-vaccination (Day 28 or 56) | |
Secondary | GMR | GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28) | Post-vaccination (Day 28 or 56) |
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