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The purpose of this study was to evaluate the antibody response to each of the four influenza vaccine strains included in the study vaccine, as measured by hemagglutination inhibition (HAI) at 4 weeks after the last dose of the study vaccine in young subjects aged between 3 years old and 17 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Aged 3 to 8 years old vaccine naïve subject (without prior seasonal influenza vaccine exposure) |
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| Group B | Active Comparator | Aged 3 to 8 years old vaccine non-naïve subject (with prior seasonal influenza vaccine exposure) |
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| Group C | Experimental | Aged 9 to 17 years old subject |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdimFlu-S (QIS) | Biological | This was an open study to demonstrate the use of AdimFlu-S (QIS) (2016-2017 season) vaccine in young subjects aged between 3 years old to 17 years old. All subjects were divided into two subgroups. That were subjects aged 3 to 8 years old, who received 2 doses of 0.5 mL vaccine separated by 4 weeks, and subjects aged 9 to 17 years old, who received one dose of 0.5 mL vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroconversion rate | The primary endpoint of immunogenicity evaluation was the seroconversion rate | Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization |
| Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by geometric mean folds increase | The primary endpoint of immunogenicity evaluation was the geometric mean folds increase | Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroprotection rate | The secondary endpoint of immunogenicity evaluation was the seroprotection rate | Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization |
| Evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S (QIS) |
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Inclusion Criteria:
Exclusion Criteria:
Main exclusion criteria:
3. Treatment discontinuation
Subject with any of the following criteria might be contraindicated to take the second vaccination:
i. Had any Grade 3 or Grade 4 adverse reaction within 7 days after first dose. ii. Had any SAE related to first dose during the follow-up of first dose. iii. Any situations met the exclusion criteria, except the exclusion criterion (1) and (8).
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
Evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of QIS. Reactogenicity events were pre-specified adverse events systematically recorded on diary cards during post-vaccination period by all participants for 7 days after each vaccination. Unsolicited adverse events were recorded on the diary card till 28 days post vaccination, while serious adverse events should be recorded throughout the study period |
| In regard to the long term safety of the study vaccine, the significant and/or serious adverse event(s) will be recorded during the 6 months follow up after the scheduled last vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |