Influenza
Conditions
Keywords
influenza infection, GSK Bio's influenza vaccine GSK2340272A
Brief summary
The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.
Interventions
BIOLOGICALGSK pandemic vaccine GSK2340272A
2 intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 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 9 years at the time of first study vaccination. * Written informed consent obtained from the parent(s) or LAR(s) of the subject. * Healthy children, as established by medical history and clinical examination when entering the study.
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. * Have received any seasonal flu vaccine since last year. * Previous administration of any H1N1 A/California-like vaccine * 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. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * 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. * History of hypersensitivity to vaccines. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures. * Acute disease and/or fever at the time of enrolment: * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38°C on rectal setting. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study. * Child in Care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen | At Day 42 | Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Seropositive Subjects for HI Antibodies | At Day 42 | A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Seroconverted Subjects in Terms of HI Antibodies | At Day 42 | Seroconversion (SCR) was defined as: For initially seronegative subjects \[pre-vaccination titer below (\<) 1:10\], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Seroprotected Subjects for HI Antibodies | At Day 42 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09. |
| Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | At Day 42 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| 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 drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination |
| Number of Subjects With Any Medically-attended Events (MAEs) | During the entire study period (from Month 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 Seropositive Subjects for HI Antibodies | At Day 0, Day 21 and Month 7 | A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within the 42-day (Days 0-41) post-vaccination period | 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 Month 0 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 Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) | During the entire study period (from Month 0 up to Month 12) | Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| HI Antibody Titers Against Vaccine H1N1 Antigen | At Day 0, Day 21 and Month 7 | Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Seroconverted Subjects in Terms of HI Antibodies | At Day 21 and Month 7 | Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below \< 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09. |
| Number of Seroprotected Subjects for HI Antibodies | At Day 0, Day 21 and Month 7 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09. |
| Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | At Day 21 and Month 7 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. |
Countries
Czechia
Participant flow
Pre-assignment details
From a total of 60 subjects enrolled in the study only 58 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| GSK2340272A F1 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule. | 7 |
| GSK2340272A F1 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule. | 13 |
| GSK2340272A F2 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule. | 5 |
| GSK2340272A F2 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule. | 15 |
| GSK2340272A F3 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule. | 6 |
| GSK2340272A F3 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule. | 12 |
| Total | 58 |
Baseline characteristics
| Characteristic | GSK2340272A F1 Y3-5 Group | GSK2340272A F1 Y6-9 Group | GSK2340272A F2 Y3-5 Group | GSK2340272A F2 Y6-9 Group | GSK2340272A F3 Y3-5 Group | GSK2340272A F3 Y6-9 Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 4.1 Years STANDARD_DEVIATION 0.9 | 7.5 Years STANDARD_DEVIATION 1.2 | 3.8 Years STANDARD_DEVIATION 0.84 | 7.3 Years STANDARD_DEVIATION 0.9 | 3.8 Years STANDARD_DEVIATION 0.98 | 7.6 Years STANDARD_DEVIATION 0.9 | 6.36 Years STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 2 Participants | 4 Participants | 1 Participants | 3 Participants | 20 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 3 Participants | 11 Participants | 5 Participants | 9 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 7 | 13 / 13 | 4 / 5 | 15 / 15 | 6 / 6 | 11 / 12 |
| serious Total, serious adverse events | 0 / 7 | 1 / 13 | 1 / 5 | 1 / 15 | 0 / 6 | 1 / 12 |
Outcome results
Primary
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (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, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A F1 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | 64 Fold change |
| GSK2340272A F2 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | 71.9 Fold change |
| GSK2340272A F3 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | 40.3 Fold change |
Primary
Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A F1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen | 954.6 Titers |
| GSK2340272A F2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen | 838.1 Titers |
| GSK2340272A F3 Group | Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen | 359.1 Titers |
Primary
Number of Seroconverted Subjects in Terms of HI Antibodies
Seroconversion (SCR) was defined as: For initially seronegative subjects \[pre-vaccination titer below (\<) 1:10\], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), 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, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A F1 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | 13 Participants |
| GSK2340272A F2 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | 9 Participants |
| GSK2340272A F3 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | 12 Participants |
Primary
Number of Seropositive Subjects for HI Antibodies
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 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, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A F1 Group | Number of Seropositive Subjects for HI Antibodies | 13 Participants |
| GSK2340272A F2 Group | Number of Seropositive Subjects for HI Antibodies | 9 Participants |
| GSK2340272A F3 Group | Number of Seropositive Subjects for HI Antibodies | 12 Participants |
Primary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually 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, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A F1 Group | Number of Seroprotected Subjects for HI Antibodies | 13 Participants |
| GSK2340272A F2 Group | Number of Seroprotected Subjects for HI Antibodies | 9 Participants |
| GSK2340272A F3 Group | Number of Seroprotected Subjects for HI Antibodies | 12 Participants |
Secondary
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 21 and Month 7
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A F1 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | Flu A/CAL/7/09, Day 21 | 28.8 Fold change |
| GSK2340272A F1 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | Flu A/CAL/7/09, Month 7 | 10.5 Fold change |
| GSK2340272A F2 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | Flu A/CAL/7/09, Day 21 | 24.5 Fold change |
| GSK2340272A F2 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | Flu A/CAL/7/09, Month 7 | 9.3 Fold change |
| GSK2340272A F3 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | Flu A/CAL/7/09, Day 21 | 13.8 Fold change |
| GSK2340272A F3 Group | Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer | Flu A/CAL/7/09, Month 7 | 9.5 Fold change |
Secondary
HI Antibody Titers Against Vaccine H1N1 Antigen
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Day 0, Day 21 and Month 7
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A F1 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Day 21 | 429.1 Titers |
| GSK2340272A F1 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Day 0 | 14.9 Titers |
| GSK2340272A F1 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Month 7 | 155.9 Titers |
| GSK2340272A F2 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Day 21 | 285.3 Titers |
| GSK2340272A F2 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Day 0 | 11.7 Titers |
| GSK2340272A F2 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Month 7 | 108.7 Titers |
| GSK2340272A F3 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Day 0 | 8.9 Titers |
| GSK2340272A F3 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Month 7 | 84.8 Titers |
| GSK2340272A F3 Group | HI Antibody Titers Against Vaccine H1N1 Antigen | Flu A/CAL/7/09, Day 21 | 123.2 Titers |
Secondary
Number of Seroconverted Subjects in Terms of HI Antibodies
Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below \< 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 21 and Month 7
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A F1 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 13 Participants |
| GSK2340272A F1 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 7 | 12 Participants |
| GSK2340272A F2 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 8 Participants |
| GSK2340272A F2 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 7 | 7 Participants |
| GSK2340272A F3 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Day 21 | 9 Participants |
| GSK2340272A F3 Group | Number of Seroconverted Subjects in Terms of HI Antibodies | Flu A/CAL/7/09, Month 7 | 10 Participants |
Secondary
Number of Seropositive Subjects for HI Antibodies
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0, Day 21 and Month 7
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A F1 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 13 Participants |
| GSK2340272A F1 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 6 Participants |
| GSK2340272A F1 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Month 7 | 13 Participants |
| GSK2340272A F2 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 9 Participants |
| GSK2340272A F2 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 3 Participants |
| GSK2340272A F2 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Month 7 | 9 Participants |
| GSK2340272A F3 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 4 Participants |
| GSK2340272A F3 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Month 7 | 12 Participants |
| GSK2340272A F3 Group | Number of Seropositive Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 12 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 0, Day 21 and Month 7
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A F1 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 13 Participants |
| GSK2340272A F1 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 6 Participants |
| GSK2340272A F1 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Month 7 | 13 Participants |
| GSK2340272A F2 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 9 Participants |
| GSK2340272A F2 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 2 Participants |
| GSK2340272A F2 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Month 7 | 8 Participants |
| GSK2340272A F3 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 2 Participants |
| GSK2340272A F3 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Month 7 | 11 Participants |
| GSK2340272A F3 Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 9 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)
Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: During the entire study period (from Month 0 up to Month 12)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A F1 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs)/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 = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. 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 with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 5 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 5 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 6 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 4 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 4 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 6 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 6 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 5 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 5 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 12 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 3 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 13 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 9 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 13 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 6 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 9 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 6 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 10 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 3 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 3 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 3 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 4 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 2 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 4 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 5 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 13 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 8 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 8 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 12 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 5 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 12 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 3 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 2 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 3 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 6 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 7 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 3 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 4 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 4 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 4 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 3 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 6 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally 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 with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 4 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 2 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 3 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 3 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 2 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever \> 39.0 °C.
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 with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 6 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 6 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 5 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 4 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 4 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 7 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 6 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 10 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 4 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 2 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 4 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 3 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 5 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 5 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 7 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 3 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 9 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 9 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 3 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 9 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 8 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 1 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 2 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 3 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 8 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 2 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 5 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Across doses | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 5 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature/(Axillary), Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 2 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature/(Axillary), Dose 2 | 0 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 Month 0 up to Month 12)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A F1 Group | Number of Subjects With Any Medically-attended Events (MAEs) | 4 Participants |
| GSK2340272A F2 Group | Number of Subjects With Any Medically-attended Events (MAEs) | 11 Participants |
| GSK2340272A F3 Group | Number of Subjects With Any Medically-attended Events (MAEs) | 5 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Any Medically-attended Events (MAEs) | 11 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Any Medically-attended Events (MAEs) | 6 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Any Medically-attended Events (MAEs) | 10 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 Month 0 to Month 12)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A F1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With 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: Within the 42-day (Days 0-41) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A F1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |
| GSK2340272A F1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 1 Participants |
| GSK2340272A F1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
| GSK2340272A F2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| GSK2340272A F2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 2 Participants |
| GSK2340272A F2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 1 Participants |
| GSK2340272A F3 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 0 Participants |
| GSK2340272A F3 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 2 Participants |
| GSK2340272A F2 Y6-9 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 2 Participants |
| GSK2340272A F3 Y3-5 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 2 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Participants |
| GSK2340272A F3 Y6-9 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Participants |