Influenza
Conditions
Keywords
influenza infection, GSK Bio's influenza vaccine GSK2340272A
Brief summary
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Interventions
BIOLOGICALPandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections and a booster IM injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
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. * 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. * Healthy children as established by medical history and clinical examination when entering into the study. * Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.
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. * Clinically or virologically confirmed influenza infection within six months preceding the study start. * Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * 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. * Acute disease and/or fever at the time of enrolment * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * Previous administration of any H1N1 A/California-like vaccine. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. * Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination. * Child in Care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Factor (SCF) for HI Antibody Titers | At Day 42 | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value | At Day 0 | The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09). |
| Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | At Day 42 | The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09. |
| Titers for Serum HI Antibodies | At Day 0 | Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | At Day 42 | A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies | At Day 42 | Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Neutralizing Antibodies | At Days 0, 21 and 42 | Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09). |
| Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | At Days 21 and 42 | A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09. |
| Number of Subjects With Normal or Abnormal Biochemical Levels | At Days 0, 21 and 42 | Among biochemical parameters assessed were alanine aminotransferase \[ALAT\], aspartate aminotransferase \[ASAT\], bilirubin \[BILI\], creatinine \[CREA\] and blood urea nitrogen \[BUN\]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | At Days 0, 21, 42 and at Month 12 | The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09. |
| Number of Subjects With Any Medically-attended Events (MAEs) | During the entire study period (from Day 0 up to Month 12) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs) | During the entire study period (from Day 0 up to Month 12) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 21-day (Days 0-20) follow-up period after the first vaccination | An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Month 12) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Titers for Serum HI Antibodies | At Days 0, 21, 42 and at Month 12 | Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | At Days 21, 42 and at Month 12 | A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Seroprotected Subjects in Terms of HI Antibodies | At Days 0, 21, 42 and at Month 12 | Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09. |
| Seroconversion Factor (SCF) for HI Antibody Titers | At Days 21, 42 and at Month 12 | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | At Days 0, 21 and 42 | The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09. |
Countries
Spain
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK2340272A (3-5Y) Group Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. | 53 |
| GSK2340272A (6-9Y) Group Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. | 57 |
| GSK2340272A (10-17Y) Group Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm. | 100 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 6 |
Baseline characteristics
| Characteristic | GSK2340272A (3-5Y) Group | GSK2340272A (6-9Y) Group | GSK2340272A (10-17Y) Group | Total |
|---|---|---|---|---|
| Age, Continuous | 3.5 Years STANDARD_DEVIATION 0.7 | 7.5 Years STANDARD_DEVIATION 1.18 | 13.3 Years STANDARD_DEVIATION 2.23 | 9.25 Years STANDARD_DEVIATION 4.46 |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Unspecified | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European heritage | 53 Participants | 56 Participants | 99 Participants | 208 Participants |
| Sex: Female, Male Female | 31 Participants | 25 Participants | 61 Participants | 117 Participants |
| Sex: Female, Male Male | 22 Participants | 32 Participants | 39 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 57 | 0 / 100 |
| other Total, other adverse events | 52 / 53 | 57 / 57 | 95 / 100 |
| serious Total, serious adverse events | 0 / 53 | 0 / 57 | 1 / 100 |
Outcome results
Primary
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | 191 Participants |
Primary
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies | 194 Participants |
Primary
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Time frame: At Day 0
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value | 40 Participants |
Primary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | 194 Participants |
Primary
Seroconversion Factor (SCF) for HI Antibody Titers
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibody Titers | 208.5 Fold increase |
Primary
Titers for Serum HI Antibodies
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies | 1538.5 Titers |
Primary
Titers for Serum HI Antibodies
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies | 7.4 Titers |
Secondary
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
Time frame: At Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | 24 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | 30 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | 25 Participants |
Secondary
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
Time frame: At Days 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | Flu A/Neth/602/09, Day 21 | 26 Participants |
| GSK2340272A Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | Flu A/Neth/602/09, Day 42 | 29 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | Flu A/Neth/602/09, Day 21 | 32 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | Flu A/Neth/602/09, Day 42 | 37 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | Flu A/Neth/602/09, Day 21 | 26 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies | Flu A/Neth/602/09, Day 42 | 29 Participants |
Secondary
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Days 21, 42 and at Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 42 | 41 Participants |
| GSK2340272A Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 41 Participants |
| GSK2340272A Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 12 | 42 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 42 | 49 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 12 | 48 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 50 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 42 | 80 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 85 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 12 | 82 Participants |
Secondary
Number of Seroprotected Subjects in Terms of HI Antibodies
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Days 0, 21, 42 and at Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 0 | 0 Participants |
| GSK2340272A Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 41 Participants |
| GSK2340272A Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 42 | 41 Participants |
| GSK2340272A Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 12 | 42 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 12 | 49 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 0 | 3 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 42 | 49 Participants |
| GSK2340272A (6-9Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 50 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 12 | 87 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 87 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 42 | 83 Participants |
| GSK2340272A (10-17Y) Group | Number of Seroprotected Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 0 | 12 Participants |
Secondary
Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: During the entire study period (from Day 0 up to Month 12)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs) | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 18 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 15 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 40 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 44 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 18 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 16 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 47 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 7 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 22 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 25 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 3 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 4 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 54 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 56 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 3 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 22 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 4 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 14 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 26 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 30 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 19 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 8 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 16 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 8 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 3 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 55 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 6 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 90 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 12 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 33 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 26 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 6 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 50 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 6 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 91 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 8 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 95 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 21 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 6 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 41 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 16 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 60 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhea, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhea, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhea, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 11 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 10 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 5 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhea, Dose 2 | 6 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhea, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhea, Dose 2 | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 17 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 15 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 15 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 21 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 17 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 6 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 5 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 6 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 26 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 23 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhea, Across doses | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhea, Across doses | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhea, Across doses | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 22 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 19 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 21 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 19 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 28 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 21 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 11 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 7 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 10 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 5 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 33 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 26 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 1 | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 21 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 20 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 9 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 25 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 24 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 15 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 7 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 1 | 9 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 10 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 2 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 29 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 28 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 9 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 26 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 26 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 16 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 16 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 7 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 20 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 19 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Across doses | 20 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 19 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 35 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 34 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 17 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 34 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 5 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 34 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 23 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 21 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 19 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 15 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 9 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 5 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 27 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 23 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 1 | 26 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 47 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 16 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 1 | 26 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 44 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 38 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 44 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 40 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 12 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 27 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 25 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 6 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 48 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 10 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 3 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 25 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 41 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 35 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 8 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 70 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 34 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 19 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 11 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 7 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 14 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 6 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 8 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 23 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 33 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 5 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 17 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 64 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 16 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 15 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 2 | 34 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Across doses | 44 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 56 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 32 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 50 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 14 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 5 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 43 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 48 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 4 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 10 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 63 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 33 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 6 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 9 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 51 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 53 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 5 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 59 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 50 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 37 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 26 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 4 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 41 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 6 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 7 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 21-day (Days 0-20) follow-up period after the first vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 29 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 22 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 4 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 30 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 6 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
Secondary
Number of Subjects With Any Medically-attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: During the entire study period (from Day 0 up to Month 12)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With Any Medically-attended Events (MAEs) | 36 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Any Medically-attended Events (MAEs) | 21 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Any Medically-attended Events (MAEs) | 33 Participants |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
Time frame: At Days 0, 21, 42 and at Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 0 Participants |
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 41 Participants |
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 42 | 41 Participants |
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Month 12 | 42 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Month 12 | 50 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 6 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 42 | 49 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 50 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Month 12 | 87 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 87 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 42 | 83 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 22 Participants |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
Time frame: At Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | 25 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | 32 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | 28 Participants |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 21 | 31 Participants |
| GSK2340272A Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 0 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 42 | 29 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 21 | 37 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 0 | 6 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 42 | 37 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 0 | 3 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 42 | 29 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Flu A/Neth/602/09, Day 21 | 30 Participants |
Secondary
Number of Subjects With Normal or Abnormal Biochemical Levels
Among biochemical parameters assessed were alanine aminotransferase \[ALAT\], aspartate aminotransferase \[ASAT\], bilirubin \[BILI\], creatinine \[CREA\] and blood urea nitrogen \[BUN\]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Unknown | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Unknown | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Above | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Within | 50 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Unknown | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Within | 28 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Unknown | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Below | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Unknown | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Unknown | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Unknown | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Within | 30 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Within | 50 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Above | 3 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Unknown | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Above | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Unknown | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Within | 50 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Within | 52 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Unknown | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Within | 28 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Unknown | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Unknown | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Within | 47 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Unknown | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Above | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Above | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Within | 28 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Within | 45 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Above | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Within | 30 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Below | 5 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Unknown | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Within | 49 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Unknown | 2 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Within | 52 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Above | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Within | 50 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Below | 0 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Within | 44 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Above | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Below | 1 Participants |
| GSK2340272A Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Below | 7 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Within | 38 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Within | 57 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Unknown | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Within | 55 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Within | 38 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Unknown | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Within | 56 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Unknown | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Within | 55 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Within | 38 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Within | 57 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Unknown | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Within | 55 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Above | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Within | 33 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Above | 5 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Below | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Within | 53 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Above | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Unknown | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Below | 2 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Within | 52 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Above | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Unknown | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Within | 37 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Above | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Within | 52 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Above | 5 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Unknown | 1 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Below | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Within | 47 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Above | 8 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Unknown | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Above | 1 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Below | 1 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Within | 94 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Within | 90 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Within | 92 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 21 | Above | 4 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 21 | Unknown | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Unknown | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Above | 1 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Above | 4 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Below | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Within | 58 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Above | 3 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Within | 85 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Above | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 42 | Above | 6 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 0 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Within | 89 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Above | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Within | 91 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Within | 59 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Within | 90 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Within | 57 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Above | 5 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 21 | Unknown | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Above | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 0 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Within | 57 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 0 | Above | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Within | 90 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 42 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 42 | Above | 3 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BILI, Day 0 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Above | 1 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Unknown | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Above | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 21 | Unknown | 2 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Below | 1 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Within | 91 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ALAT, Day 21 | Within | 94 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Within | 54 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | ASAT, Day 42 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | BUN, Day 42 | Below | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Normal or Abnormal Biochemical Levels | CREA, Day 0 | Above | 4 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Day 0 up to Month 12)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2340272A (6-9Y) Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2340272A (10-17Y) Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Seroconversion Factor (SCF) for HI Antibody Titers
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Days 21, 42 and at Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Day 42 | 316.2 Fold increase |
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Day 21 | 33.7 Fold increase |
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Month 12 | 24.8 Fold increase |
| GSK2340272A (6-9Y) Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Day 42 | 151.7 Fold increase |
| GSK2340272A (6-9Y) Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Day 21 | 44.9 Fold increase |
| GSK2340272A (6-9Y) Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Month 12 | 16.8 Fold increase |
| GSK2340272A (10-17Y) Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Day 21 | 61.8 Fold increase |
| GSK2340272A (10-17Y) Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Month 12 | 28.3 Fold increase |
| GSK2340272A (10-17Y) Group | Seroconversion Factor (SCF) for HI Antibody Titers | Flu A/CAL/7/09, Day 42 | 119.8 Fold increase |
Secondary
Titers for Serum HI Antibodies
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Days 0, 21, 42 and at Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 0 | 5.0 Titers |
| GSK2340272A Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 21 | 168.3 Titers |
| GSK2340272A Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 42 | 1581.1 Titers |
| GSK2340272A Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Month 12 | 123.9 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Month 12 | 106.3 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 0 | 6.3 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 42 | 964.6 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 21 | 284.4 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Month 12 | 251.0 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 21 | 547.9 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 42 | 1008.9 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum HI Antibodies | Flu A/CAL/7/09, Day 0 | 8.9 Titers |
Secondary
Titers for Serum Neutralizing Antibodies
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.
Time frame: At Month 12
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum Neutralizing Antibodies | 269.1 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum Neutralizing Antibodies | 168.4 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum Neutralizing Antibodies | 118.1 Titers |
Secondary
Titers for Serum Neutralizing Antibodies
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 21 | 60.2 Titers |
| GSK2340272A Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 0 | 4.1 Titers |
| GSK2340272A Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 42 | 1277.4 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 21 | 149.0 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 0 | 6.1 Titers |
| GSK2340272A (6-9Y) Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 42 | 751.0 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 0 | 5.3 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 42 | 553.4 Titers |
| GSK2340272A (10-17Y) Group | Titers for Serum Neutralizing Antibodies | Flu A/Neth/602/09, Day 21 | 113.0 Titers |