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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable
Representative(s) (LAR) can and will comply with the requirements of the protocol.
- For non US countries:
- - Children, male or female, aged between 6 months and 17 years at the time of the
first study vaccination.
For US :
- Children, male or female, aged between 3 and 17 years at the time of the first study
vaccination
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject.
Assent obtained from the subject when applicable.
- Subjects in stable health as determined by investigator's clinical examination and
assessment of subjects' medical history.
- Written informed assent obtained from the subject if/as required by local regulations.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the
subject:
- - has practiced adequate contraception for 30 days prior to vaccination,
- - and has a negative urine pregnancy test on the day of vaccination,
- - and has agreed to continue adequate contraception during the entire treatment period
and for 2 months after completion of the vaccination series
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine
within 30 days preceding the first dose of the study vaccine or planned use during the
study period. Routine registered childhood vaccinations are permitted.
- Planned administration of any vaccine 30 days prior and 30 days after any study
vaccine administration.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by medical history and physical examination.
- Prior receipt of any seasonal or pandemic influenza vaccine (registered or
investigational) within 6 months preceding the first dose of study vaccine, or planned
use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within
three months prior to enrolment in this study or planned administration during the
study period.
- Administration of immunoglobulins and/or any blood products within the three months
prior to the enrolment in this study, or planned during the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.
- History of seizures or progressive neurological disease.
- History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated
influenza virus vaccine.
- Concurrently participating in another clinical study, at any time during the study
period in which the subject has been or will be exposed to an investigational or a
non-investigational product .
- History of hypersensitivity to a previous dose of influenza vaccine, history of any
reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
- Acute disease and/or fever at the time of enrolment
- Ongoing aspirin therapy
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive
precautions.
- Any other condition which, in the opinion of the investigator, prevents the subject
from participating in the study
- Child in Care.
Age minimum:
6 Months
Age maximum:
17 Years
Gender:
All
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Secondary Outcome(s)
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
[Time Frame: During the 7-day (Days 0-6) follow-up period after any vaccination.]
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Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
[Time Frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]
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Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).
[Time Frame: During the entire study period (Day 0 - Day 180)]
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
[Time Frame: During the 7-day (Days 0-6) follow-up period after any vaccination.]
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Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
[Time Frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]
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Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
[Time Frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]
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Number of Days With Solicited Local Symptoms.
[Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination.]
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Number of Subjects With Any and Related Serious Adverse Events (SAEs).
[Time Frame: During the entire study period (Day 0 - Day 180)]
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Number of Seroprotected Subjects Against 4 Strains of Influenza.
[Time Frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
[Time Frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]
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Number of Days With Solicited General Symptoms
[Time Frame: During the 7-day (Days 0-6) follow-up period after vaccination.]
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Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
[Time Frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
[Time Frame: During the 28-day (Days 0-27) follow-up period after any vaccination.]
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Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
[Time Frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]
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Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
[Time Frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]
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Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
[Time Frame: During the entire study period (Day 0 - Day 180)]
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
[Time Frame: During the 7-day (Days 0-6) follow-up period after any vaccination.]
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