Influenza
Conditions
Keywords
Influenza Vaccine, Immunogenicity
Brief summary
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.
Interventions
BIOLOGICALAdimFlu-S (QIS)
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.
Sponsors
Adimmune Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Boys or girls aged 3 years old to 17 years old on the day of first vaccination; 2. Subject and/or parents(s)/legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits; 3. Subject must be in good physical health on the basis of medical history, physical examination; 4. Subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
Exclusion criteria
Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroconversion rate | Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization | The primary endpoint of immunogenicity evaluation was the seroconversion rate |
| Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by geometric mean folds increase | Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization | The primary endpoint of immunogenicity evaluation was the geometric mean folds increase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroprotection rate | Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization | The secondary endpoint of immunogenicity evaluation was the seroprotection rate |
| 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) | 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 | 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 |
Outcome results
None listed