Influenza
Conditions
Keywords
Influenza, Korea, FluarixTM
Brief summary
The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).
Interventions
BIOLOGICALFluarixTM
All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female \> 6 months of age at the time of the first vaccination. * Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study. * If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
Exclusion criteria
* Clinical signs of acute febrile illness at the time of entry into the study. * Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Severe Unsolicited Adverse Events | During the 21-day follow-up period (Day 0 to Day 20) after vaccination | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | During the 4-day follow up (Day 0 to 3) after vaccination. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis. |
| Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | During the 4-day follow up (Day 0 to 3) after vaccination. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis. |
| Number of Participant Reporting Unsolicited Adverse Events. | During the 21-day follow-up period (Day 0 to Day 20) after vaccination | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Number of Participants Reporting Serious Adverse Events (SAE). | Within 1 month following vaccination | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unprimed, > 6 to < 72 Months Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed). | 294 |
| Unprimed, ≥ 72 to < 108 Months Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed). | 1 |
| Primed, > 6 to < 72 Months Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed). | 384 |
| Primed, ≥ 72 to < 108 Months Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed). | 79 |
| Primed, ≥ 108 to < 216 Months Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed). | 46 |
| Primed, ≥ 216 Months Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). | 71 |
| Total | 875 |
Baseline characteristics
| Characteristic | Primed, > 6 to < 72 Months | Primed, ≥ 72 to < 108 Months | Primed, ≥ 108 to < 216 Months | Primed, ≥ 216 Months | Total | Unprimed, > 6 to < 72 Months | Unprimed, ≥ 72 to < 108 Months |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.3 months STANDARD_DEVIATION 18.8 | 86.4 months STANDARD_DEVIATION 10.6 | 132.7 months STANDARD_DEVIATION 22 | 454.5 months STANDARD_DEVIATION 174.4 | 73.2 months STANDARD_DEVIATION 128.07 | 13.7 months STANDARD_DEVIATION 10.6 | 85.0 months STANDARD_DEVIATION 0 |
| Sex: Female, Male Female | 178 Participants | 41 Participants | 27 Participants | 56 Participants | 445 Participants | 142 Participants | 1 Participants |
| Sex: Female, Male Male | 206 Participants | 38 Participants | 19 Participants | 15 Participants | 430 Participants | 152 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 294 | 0 / 1 | 90 / 384 | 27 / 79 | 10 / 46 | 11 / 71 |
| serious Total, serious adverse events | 1 / 294 | 0 / 1 | 0 / 384 | 0 / 79 | 0 / 46 | 0 / 71 |
Outcome results
Primary
Number of Participants Reporting Severe Unsolicited Adverse Events
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities
Time frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Severe Unsolicited Adverse Events | 0 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Severe Unsolicited Adverse Events | 0 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Severe Unsolicited Adverse Events | 0 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Severe Unsolicited Adverse Events | 0 participants |
| Primed, ≥ 108 to < 216 Months | Number of Participants Reporting Severe Unsolicited Adverse Events | 0 participants |
| Primed, ≥ 216 Months | Number of Participants Reporting Severe Unsolicited Adverse Events | 0 participants |
Secondary
Number of Participant Reporting Unsolicited Adverse Events.
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unprimed, > 6 to < 72 Months | Number of Participant Reporting Unsolicited Adverse Events. | 28 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participant Reporting Unsolicited Adverse Events. | 0 participants |
| Primed, > 6 to < 72 Months | Number of Participant Reporting Unsolicited Adverse Events. | 67 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participant Reporting Unsolicited Adverse Events. | 12 participants |
| Primed, ≥ 108 to < 216 Months | Number of Participant Reporting Unsolicited Adverse Events. | 6 participants |
| Primed, ≥ 216 Months | Number of Participant Reporting Unsolicited Adverse Events. | 3 participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAE).
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: Within 1 month following vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Serious Adverse Events (SAE). | 1 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Serious Adverse Events (SAE). | 0 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Serious Adverse Events (SAE). | 0 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Serious Adverse Events (SAE). | 0 participants |
| Primed, ≥ 108 to < 216 Months | Number of Participants Reporting Serious Adverse Events (SAE). | 0 participants |
| Primed, ≥ 216 Months | Number of Participants Reporting Serious Adverse Events (SAE). | 0 participants |
Secondary
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.
Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.
Time frame: During the 4-day follow up (Day 0 to 3) after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Headache | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fever | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Induration | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Shivering | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fatigue | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Redness | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Pain | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Myalgia | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Malaise | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Swelling | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Sweating/diaphoresis | 0 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Shivering | 0 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Pain | 23 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Redness | 11 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Swelling | 10 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Induration | 8 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fatigue | 3 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fever | 2 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Headache | 4 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Malaise | 1 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Myalgia | 6 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Sweating/diaphoresis | 0 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Shivering | 0 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fever | 1 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Swelling | 6 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Headache | 2 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Pain | 7 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Malaise | 1 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Redness | 7 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Sweating/diaphoresis | 0 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Myalgia | 3 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Induration | 5 participants |
| Primed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fatigue | 3 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fatigue | 2 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Sweating/diaphoresis | 2 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Fever | 0 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Swelling | 4 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Shivering | 2 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Myalgia | 5 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Headache | 1 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Redness | 4 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Pain | 10 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Induration | 4 participants |
| Primed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Malaise | 1 participants |
Secondary
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.
Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.
Time frame: During the 4-day follow up (Day 0 to 3) after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Redness | 3 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Fever | 7 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Pain | 3 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Shivering | 0 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Swelling | 2 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Sweating/diaphoresis | 1 participants |
| Unprimed, > 6 to < 72 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Induration | 3 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Sweating/diaphoresis | 2 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Induration | 22 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Pain | 58 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Redness | 40 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Swelling | 36 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Fever | 9 participants |
| Unprimed, ≥ 72 to < 108 Months | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Shivering | 3 participants |