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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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