A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children

This study will enroll 3 age cohorts:

Adults: 18-49 years, Children: 3-17 years and 6-35 months of age.

Inclusion Criteria:

Adults 18-49 years cohort:

- A male or female between, and including, 18 and 49 years of age at the time of
vaccination.

- Subjects who the investigator believes that they/their parent(s)/Legally Acceptable
Representatives (LAR(s)) can and will comply with the requirements of the protocol.

- Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.

- Written informed assent obtained from the subject if/as required by local regulations.

- Healthy subjects or those with chronic well-controlled disease as established by
medical history and clinical examination before entering into the study.

- Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, ovariectomy.

- 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 pregnancy test on the day of vaccination, and has agreed to continue
adequate contraception for 2 months after vaccination.

Pediatric cohort:

United States:

• A male or female subject between, and including, the ages of 3 and 17 years in the United
States.

Rest of the World:

• A male or female subject between, and including, the ages of 6 months to 17 years all
countries with the exception of the United States.

All participating countries:

- Subjects who the investigator believes that they/their parent(s)/Legally Acceptable
Representatives (LAR(s)) can and will comply with the requirements of the protocol.

- Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.

- Written informed assent obtained from the subject if/as required by local regulations.

- Healthy subjects or those with chronic well-controlled disease as established by
medical history and clinical examination before entering into the study.

- Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, ovariectomy.

- 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 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:

Adults aged 18-49 years cohort:

- Child in care.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine, or planned use
during the study period.

- 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 (pharmaceutical or device).

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs within 6 months prior to the first vaccine dose.
Inhaled and topical steroids are allowed.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.

- Any administration of a long-acting immune-modifying drug within 6 months before study
start, or planned administration during the study period.

- Administration of an influenza vaccine during the 6 months preceding entry into the
study.

- Administration of a vaccine not foreseen by the study protocol within 30 days before
vaccination or planned administration during the study period.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.

- Any known or suspected allergy to any constituent of influenza vaccines (including egg
proteins); a history of anaphylactic-type reaction to consumption of eggs; or a
history of severe adverse reaction to a previous influenza vaccine.

- Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or
renal functional abnormality, as determined by physical examination or laboratory
tests.

- Any history of Guillain-Barré Syndrome.

- Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥
38.0ºC/100.4ºF.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- History of chronic alcohol consumption and/or drug abuse.

- Any contra-indication to intramuscular administration of influenza vaccines.

- Any other condition which, in the opinion of the investigator, prevents the subject
from participating in the study.

Pediatric cohort

- Child in care.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine, or planned use
during the study period.

- 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 (pharmaceutical or device).

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs within 6 months prior to the first vaccination dose.
Inhaled and topical steroids are allowed.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.

- Any administration of a long-acting immune-modifying drug within 6 months before study
start, or planned administration during the study period.

- Administration of an influenza vaccine during the 6 months preceding entry into the
study.

- Administration of a vaccine not foreseen by the study protocol within 30 days before
vaccination or planned administration during the study period.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.

- Any known or suspected allergy to any constituent of influenza vaccines (including egg
proteins); a history of anaphylactic-type reaction to consumption of eggs; or a
history of severe adverse reaction to a previous influenza vaccine.

- Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or
renal functional abnormality, as determined by physical examination or laboratory
tests.

- Any history of Guillain-Barré Syndrome.

- Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥
38.0ºC/100.4ºF.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- History of chronic alcohol consumption and/or drug abuse.

- Any contra-indication to intramuscular administration of influenza vaccines.

- Any other condition which, in the opinion of the investigator, prevents the subject
from participating in the study.