Influenza
Conditions
Keywords
Influenza, H1N1, Pandemic
Brief summary
The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.
Interventions
BIOLOGICALGSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)
Intramuscular injection, one or two doses
BIOLOGICALGSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)
Intramuscular injection, two doses
BIOLOGICALPlacebo
Intramuscular injection, one dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female children 6 months to less than 10 years of age at the time of the first vaccination. Less than 10 years of age implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of first vaccine dose under this protocol. * Written informed consent obtained from the subject's parent(s)/legally acceptable representative(s) (LAR(s)); written informed assent obtained from the subject if appropriate pre local requirements). * Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment. * Parent(s)/LAR(s) available and accessible for active surveillance contacts. * Parent(s)/LAR(s) and (if age-appropriate, subjects) who, in the investigator's opinion, can and will comply with the requirements of the protocol as documented by signature on the informed consent document. * Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.
Exclusion criteria
* Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine. * Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus. * Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/LAR(s) unable/unlikely to provide accurate safety reports. * Presence of a temperature ≥ 38.0ºC (≥ 100.4ºF) by any route or method, or acute symptoms greater than mild severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed. * Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible. * An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine. * Administration of any licensed live attenuated vaccine within 4 weeks before the first vaccination or of any licensed inactivated vaccine within 2 weeks before the first vaccination. * Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate. * Planned use of a pandemic monovalent A/California/7/2009 (H1N1)v-like virus vaccine other than the study vaccines during the study period. * Planned administration of seasonal trivalent influenza vaccine during the 4 month period following Day 0. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days before the first dose of study vaccine, or planned use during the study period. * Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least One A/California Influenza Event | From 14 days after first vaccination until study conclusion on Day 385 | The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | From 14 days after first vaccination until study conclusion on Day 385 | The influenza virus presence was confirmed by a positive culture. |
| Number of Subjects With at Least One Pneumonia Event | From 14 days after first vaccination until study conclusion on Day 385 | — |
| Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | From Day 0 until study end at Day 385 | Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. |
| Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | From Day 0 until study end at Day 385 | Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day follow-up period (Day 0 - Day 6) after 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 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness which prevented normal everyday activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (gastro.sympt.), headache, joint pain at other location, muscle aches, shivering, sweating and temperature \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = Incidence of a particular symptom regardless of intensity grade or relationship to study vaccination. Grade 3 = symptom which prevented normal everyday activity. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | Up to Day 385 | 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. |
| Number of Subjects With Any Medically-attended Adverse Events (MAEs) | Up to Day 385 | 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 Reporting at Least One A/California Influenza Event | From 42 days after first vaccination until study conclusion on Day 385 | The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR). |
| Number of Subjects With Serious Adverse Events (SAEs) | Up to Day 385 | 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. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | At Days 0 and 42 | Titers are presented as geometric mean titers (GMTs). |
| Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | At Days 0 and 42 | A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10. |
| Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | At Day 42 | Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. |
| Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | At Days 0 and 42 | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | At Day 42 | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0. |
| Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | At Day 42 | The geometric mean titer ratio (GMT ratio) was defined as the ratio of geometric mean of the post-vaccination reciprocal HI titer between groups. The analysis was not performed for Day 182 and Day 385 as planned per protocol. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | At Days 0 and 182 | Titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | From Day 0 to Day 42 | 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. |
Countries
Australia, Brazil, Colombia, Costa Rica, Mexico, Philippines, Singapore, Thailand
Participant flow
Pre-assignment details
Out of the 1654 subjects enrolled, study vaccine was not administered but subject number was allocated to 9 subjects. These 9 subjects were excluded from the study, therefore leading to 1645 subjects starting the study.
Participants by arm
| Arm | Count |
|---|---|
| Arepanrix 2D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. | 610 |
| Arepanrix 2D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). | 1,438 |
| Arepanrix 1D 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. | 612 |
| Arepanrix 1D 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). | 1,436 |
| GSK2340273A 6M-3Y Group Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. | 613 |
| GSK2340273A 3Y-10Y Group Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). | 1,436 |
| Total | 6,145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Consent not received from both parents | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Data not reliable | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Failure to comply with protocol | 0 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 13 | 22 | 15 | 17 | 10 | 24 |
| Overall Study | Migrated/moved from study area | 1 | 6 | 6 | 8 | 7 | 3 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 2 | 1 |
| Overall Study | Refused blood sampling | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Subject lost legal representation | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Unable to attend visit(s) | 2 | 4 | 2 | 1 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 16 | 30 | 13 | 28 | 12 | 34 |
Baseline characteristics
| Characteristic | Arepanrix 2D 6M-3Y Group | Arepanrix 2D 3Y-10Y Group | Arepanrix 1D 6M-3Y Group | Arepanrix 1D 3Y-10Y Group | GSK2340273A 6M-3Y Group | GSK2340273A 3Y-10Y Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 21.0 Months STANDARD_DEVIATION 8.8 | 73.4 Months STANDARD_DEVIATION 23.8 | 21.2 Months STANDARD_DEVIATION 8.8 | 73.2 Months STANDARD_DEVIATION 24.2 | 21.2 Months STANDARD_DEVIATION 8.6 | 73.2 Months STANDARD_DEVIATION 24.3 | 57.7 Months STANDARD_DEVIATION 31.6 |
| Race/Ethnicity, Customized African Heritage/African American | 8 Participants | 22 Participants | 4 Participants | 22 Participants | 3 Participants | 26 Participants | 85 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian-South East Asian Heritage | 297 Participants | 507 Participants | 301 Participants | 503 Participants | 297 Participants | 499 Participants | 2404 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific islander | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 235 Participants | 731 Participants | 246 Participants | 745 Participants | 243 Participants | 734 Participants | 2934 Participants |
| Race/Ethnicity, Customized White-Arabic/North African Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Caucasian/European Heritage | 68 Participants | 172 Participants | 59 Participants | 161 Participants | 68 Participants | 165 Participants | 693 Participants |
| Sex: Female, Male Female | 291 Participants | 688 Participants | 308 Participants | 748 Participants | 291 Participants | 732 Participants | 3058 Participants |
| Sex: Female, Male Male | 319 Participants | 750 Participants | 304 Participants | 688 Participants | 322 Participants | 704 Participants | 3087 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 | 1 / 610 | 1 / 1,438 | 1 / 612 | 0 / 1,436 | 0 / 613 | 0 / 1,436 |
| other Total, other adverse events | 498 / 610 | 1,116 / 1,438 | 439 / 612 | 1,047 / 1,436 | 446 / 613 | 891 / 1,436 |
| serious Total, serious adverse events | 35 / 610 | 41 / 1,438 | 29 / 612 | 37 / 1,436 | 33 / 613 | 35 / 1,436 |
Outcome results
Primary
Number of Subjects Reporting at Least One A/California Influenza Event
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Time frame: From 14 days after first vaccination until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects Reporting at Least One A/California Influenza Event | 3 Participants |
| Arepanrix 1D Group | Number of Subjects Reporting at Least One A/California Influenza Event | 7 Participants |
| GSK2340273A Group | Number of Subjects Reporting at Least One A/California Influenza Event | 13 Participants |
Comparison: Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.95% CI: [18.53, 93.39]
Secondary
Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
The geometric mean titer ratio (GMT ratio) was defined as the ratio of geometric mean of the post-vaccination reciprocal HI titer between groups. The analysis was not performed for Day 182 and Day 385 as planned per protocol.
Time frame: At Day 42
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arepanrix 2D Group | Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | 278.9 Adjusted GMT ratio |
| Arepanrix 1D Group | Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | 1548.5 Adjusted GMT ratio |
| GSK2340273A Group | Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | 275.8 Adjusted GMT ratio |
Comparison: Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).95% CI: [4.92, 6.41]
Comparison: Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).95% CI: [0.93, 1.19]
Secondary
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Day 42
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 228 Participants |
| Arepanrix 1D Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 166 Participants |
| GSK2340273A Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 224 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 149 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 187 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 155 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Day 385
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 58 Participants |
| Arepanrix 1D Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 30 Participants |
| GSK2340273A Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 35 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 17 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 18 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 18 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Day 182
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 66 Participants |
| Arepanrix 1D Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 38 Participants |
| GSK2340273A Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 54 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 33 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 32 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain | 34 Participants |
Secondary
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.
Time frame: At Days 0 and 42
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with both doses of study vaccine/placebo administered per protocol treatment assignment and assay results for antibodies against A/California at the relevant timepoints were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 66 Participants |
| Arepanrix 2D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 233 Participants |
| Arepanrix 1D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 82 Participants |
| Arepanrix 1D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 167 Participants |
| GSK2340273A Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 62 Participants |
| GSK2340273A Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 232 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 69 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 156 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 60 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 220 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 73 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 163 Participants |
Secondary
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.
Time frame: At Days 0 and 182
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 20 Participants |
| Arepanrix 2D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 186 Participants |
| Arepanrix 1D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 15 Participants |
| Arepanrix 1D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 378 Participants |
| GSK2340273A Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 17 Participants |
| GSK2340273A Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 177 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 29 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 384 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 17 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 174 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 18 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 377 Participants |
Secondary
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seropositive subject was defined as a subject whose HI titers was greater than or equal to (≥) 1:10.
Time frame: At Days 0 and 385
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 173 Participants |
| Arepanrix 2D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 12 Participants |
| Arepanrix 1D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 16 Participants |
| Arepanrix 1D Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 349 Participants |
| GSK2340273A Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 11 Participants |
| GSK2340273A Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 163 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 14 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 334 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 14 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 142 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 14 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 333 Participants |
Secondary
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Time frame: At Days 0 and 182
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 19 Participants |
| Arepanrix 2D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 184 Participants |
| Arepanrix 1D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 10 Participants |
| Arepanrix 1D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 374 Participants |
| GSK2340273A Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 16 Participants |
| GSK2340273A Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 120 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 17 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 288 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 17 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 117 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 14 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 182 | 337 Participants |
Secondary
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Time frame: At Days 0 and 385
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 169 Participants |
| Arepanrix 2D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 11 Participants |
| Arepanrix 1D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 12 Participants |
| Arepanrix 1D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 339 Participants |
| GSK2340273A Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 10 Participants |
| GSK2340273A Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 128 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 266 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 10 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 11 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 82 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 259 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 9 Participants |
Secondary
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Time frame: At Days 0 and 42
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with both doses of study vaccine/placebo administered per protocol treatment assignment and assay results for antibodies against A/California at the relevant timepoints were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 61 Participants |
| Arepanrix 2D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 233 Participants |
| Arepanrix 1D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 66 Participants |
| Arepanrix 1D Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 167 Participants |
| GSK2340273A Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 55 Participants |
| GSK2340273A Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 229 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 154 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 45 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 55 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 199 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 53 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 160 Participants |
Secondary
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
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: Up to Day 385
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. This analysis compared the different treatment groups based on the type of vaccine received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Arepanrix 1D Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | 2 Participants |
| GSK2340273A Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | 3 Participants |
Secondary
Number of Subjects Reporting at Least One A/California Influenza Event
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Time frame: From Day 0 until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects Reporting at Least One A/California Influenza Event | 4 Participants |
| Arepanrix 1D Group | Number of Subjects Reporting at Least One A/California Influenza Event | 9 Participants |
| GSK2340273A Group | Number of Subjects Reporting at Least One A/California Influenza Event | 13 Participants |
Secondary
Number of Subjects Reporting at Least One A/California Influenza Event
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Time frame: From 42 days after first vaccination until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects Reporting at Least One A/California Influenza Event | 3 Participants |
| Arepanrix 1D Group | Number of Subjects Reporting at Least One A/California Influenza Event | 5 Participants |
| GSK2340273A Group | Number of Subjects Reporting at Least One A/California Influenza Event | 9 Participants |
Secondary
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
Time frame: From Day 0 until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 3 Participants |
| Arepanrix 1D Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 7 Participants |
| GSK2340273A Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 8 Participants |
Secondary
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
Time frame: From 14 days after first vaccination until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 2 Participants |
| Arepanrix 1D Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 6 Participants |
| GSK2340273A Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 8 Participants |
Secondary
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
Time frame: From 42 days after first vaccination until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 2 Participants |
| Arepanrix 1D Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 4 Participants |
| GSK2340273A Group | Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event | 5 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 100 millimeters (mm) of injection site.
Time frame: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, from the age strata groups, who received at least 1 dose of study vaccine and who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 31 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 8 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 213 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 288 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 24 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 14 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 13 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 12 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 24 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 11 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 20 Participants |
| Arepanrix 2D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 204 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 19 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 16 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 42 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 9 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 16 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 30 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 369 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 39 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 454 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 344 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 24 Participants |
| Arepanrix 1D Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 7 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 25 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 34 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 17 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 25 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 21 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 16 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 487 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 416 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 23 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 347 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 13 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 38 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 16 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 13 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 8 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 17 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 189 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 222 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 8 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 17 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 104 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 153 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 357 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 24 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 8 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 16 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 4 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 382 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 28 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 8 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 17 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 27 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 25 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 18 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 30 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 133 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 431 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 18 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 4 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 409 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 1 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 32 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 5 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 3 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 122 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 154 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 10 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 86 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 2 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| GSK2340273A 6M-3Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 212 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 6 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 2 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 258 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 10 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 7 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 157 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 16 Participants |
| GSK2340273A 3Y-6Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 11 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 15 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 213 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 7 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 13 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 322 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 10 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 4 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 6 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 6 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 254 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 Participants |
| GSK2340273A 6Y-10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness which prevented normal everyday activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, from the age strata groups, who received at least 1 dose of study vaccine and who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Across doses | 120 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 2 | 164 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Across doses | 122 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 1 | 109 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 1 | 5 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 2 | 73 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Across doses | 198 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Across doses | 175 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 1 | 62 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 1 | 7 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Across doses | 143 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Across doses | 47 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Across doses | 237 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Across doses | 16 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 2 | 29 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 1 | 68 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 2 | 9 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 1 | 105 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 1 | 7 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Across doses | 14 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Across doses | 182 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 1 | 77 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 1 | 97 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 2 | 148 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 2 | 81 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Across doses | 15 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 2 | 115 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 1 | 18 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 2 | 114 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 1 | 149 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Across doses | 163 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 2 | 10 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 1 | 45 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 2 | 8 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 2 | 112 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 2 | 113 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 1 | 103 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 2 | 92 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 2 | 74 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Across doses | 145 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Across doses | 160 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 2 | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 1 | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 2 | 65 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 2 | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Across doses | 116 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 2 | 95 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Across doses | 18 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Across doses | 10 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 2 | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 1 | 70 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 1 | 70 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 2 | 72 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 2 | 96 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Across doses | 160 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 2 | 11 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Across doses | 109 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 1 | 106 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 2 | 56 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Across doses | 7 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 1 | 5 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Across doses | 107 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 1 | 64 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Across doses | 170 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 1 | 59 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 1 | 7 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 2 | 99 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Across doses | 120 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 1 | 7 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 1 | 99 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 1 | 40 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Across doses | 5 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 1 | 50 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 2 | 61 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 2 | 22 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 2 | 12 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 2 | 27 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 2 | 44 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 1 | 128 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Across doses | 124 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 1 | 3 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 1 | 93 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Across doses | 71 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 1 | 82 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 2 | 7 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 1 | 89 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Across doses | 83 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Across doses | 12 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 1 | 5 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Across doses | 126 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 1 | 51 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 1 | 88 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Across doses | 104 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 1 | 21 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Across doses | 5 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 1 | 63 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 1 | 3 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 2 | 53 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Across doses | 164 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 2 | 3 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Across doses | 71 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 2 | 32 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Across doses | 33 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 2 | 81 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Across doses | 6 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 2 | 2 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Across doses | 124 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 2 | 44 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 1 | 63 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 1 | 112 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 1 | 1 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 1 | 74 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 1 | 111 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 1 | 1 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 1 | 80 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 1 | 97 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 1 | 4 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 1 | 15 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 1 | 55 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 1 | 39 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 2 | 58 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 2 | 3 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 2 | 42 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 2 | 63 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 2 | 2 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 2 | 46 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 2 | 67 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 2 | 2 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 2 | 49 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 2 | 47 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 2 | 10 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 2 | 27 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Across doses | 137 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Across doses | 4 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Across doses | 97 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Across doses | 139 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Across doses | 3 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Across doses | 109 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Across doses | 134 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Across doses | 6 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Across doses | 94 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Across doses | 97 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Across doses | 25 Participants |
| Arepanrix 1D 6M-3Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Across doses | 62 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 2 | 6 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 1 | 63 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Across doses | 8 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 2 | 73 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Across doses | 175 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 2 | 6 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 1 | 8 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Across doses | 190 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 1 | 116 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 1 | 3 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Across doses | 14 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Across doses | 149 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 2 | 52 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 1 | 83 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 1 | 25 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 2 | 104 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Across doses | 109 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Across doses | 51 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 1 | 2 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Across doses | 8 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 1 | 135 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 1 | 56 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 1 | 106 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 2 | 56 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 1 | 18 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 2 | 62 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Across doses | 92 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 2 | 6 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Across doses | 97 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 2 | 14 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 1 | 45 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Across doses | 30 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 2 | 102 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Across doses | 121 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 2 | 28 Participants |
| Arepanrix 1D 3Y-6Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 2 | 64 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 2 | 19 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 2 | 2 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Across doses | 34 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Across doses | 133 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 2 | 48 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 1 | 62 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Across doses | 6 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Dose 2 | 41 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 2 | 1 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Drowsiness, Across doses | 89 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 2 | 59 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Drowsiness, Dose 1 | 5 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Across doses | 95 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Temperature, Dose 1 | 16 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 1 | 3 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Across doses | 2 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 1 | 33 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Across doses | 66 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 1 | 45 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 1 | 5 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Across doses | 6 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Across doses | 115 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 1 | 82 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Across doses | 7 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 1 | 43 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Irritability, Dose 1 | 1 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Drowsiness, Dose 1 | 101 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Across doses | 69 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Irritability, Dose 1 | 67 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Loss of appetite, Dose 2 | 34 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Dose 2 | 31 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Loss of appetite, Dose 2 | 2 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Grade 3 Temperature, Dose 2 | 4 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Loss of appetite, Dose 2 | 53 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Any Temperature, Across doses | 59 Participants |
| Arepanrix 1D 6Y-10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years | Related Irritability, Dose 2 | 34 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (gastro.sympt.), headache, joint pain at other location, muscle aches, shivering, sweating and temperature \[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = Incidence of a particular symptom regardless of intensity grade or relationship to study vaccination. Grade 3 = symptom which prevented normal everyday activity. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, from the age strata groups, who received at least 1 dose of study vaccine and who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Dose 1 | 3 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Across doses | 102 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Dose 2 | 14 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Dose 1 | 46 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Dose 2 | 7 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Dose 2 | 61 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Dose 1 | 105 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Across doses | 21 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Across doses | 51 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Dose 1 | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Dose 2 | 25 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Dose 1 | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Dose 2 | 3 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Dose 1 | 18 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Across doses | 165 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Dose 1 | 5 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Across doses | 139 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Dose 2 | 36 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Dose 2 | 22 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Dose 1 | 34 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Dose 1 | 27 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Dose 1 | 81 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Dose 1 | 7 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Dose 1 | 28 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Dose 2 | 1 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Dose 1 | 26 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Dose 2 | 34 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Dose 2 | 82 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Dose 2 | 105 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Dose 2 | 89 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Across doses | 73 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Dose 2 | 42 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Dose 2 | 10 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Across doses | 3 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Dose 2 | 5 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Dose 2 | 34 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Across doses | 11 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Dose 2 | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Dose 2 | 105 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Dose 2 | 148 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Across doses | 89 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Across doses | 38 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Across doses | 63 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Across doses | 168 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Dose 2 | 68 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Dose 1 | 90 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Across doses | 56 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Dose 1 | 6 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Across doses | 131 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Across doses | 16 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Dose 1 | 65 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Across doses | 36 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Across doses | 231 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Dose 1 | 41 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Dose 2 | 23 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Across doses | 42 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Dose 1 | 5 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Dose 1 | 9 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Across doses | 7 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Dose 1 | 22 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Across doses | 5 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Across doses | 66 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Dose 1 | 141 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Dose 2 | 9 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Across doses | 104 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Dose 1 | 21 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Across doses | 14 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Dose 1 | 103 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Dose 2 | 61 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Dose 2 | 42 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Dose 1 | 63 Participants |
| Arepanrix 2D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Across doses | 7 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Across doses | 22 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Dose 1 | 31 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Dose 1 | 1 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Dose 1 | 19 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Dose 1 | 29 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Dose 1 | 1 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Dose 1 | 19 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Dose 2 | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Dose 2 | 19 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Dose 2 | 75 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Dose 2 | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Dose 2 | 10 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Dose 2 | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Across doses | 118 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Across doses | 41 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Across doses | 6 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Across doses | 67 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Across doses | 41 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Dose 1 | 82 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Dose 1 | 4 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Dose 1 | 52 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Dose 1 | 45 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Dose 1 | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Dose 1 | 27 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Dose 1 | 129 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Dose 1 | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Dose 1 | 87 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Dose 1 | 65 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Dose 1 | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Dose 1 | 43 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Dose 1 | 116 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Dose 1 | 14 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Dose 1 | 6 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Dose 1 | 32 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Dose 1 | 84 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Dose 1 | 8 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Dose 2 | 51 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Dose 2 | 37 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Dose 2 | 28 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Dose 2 | 48 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Dose 2 | 35 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Dose 2 | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Dose 2 | 28 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Dose 2 | 48 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Dose 2 | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Dose 2 | 41 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Dose 2 | 15 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Dose 2 | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Dose 2 | 15 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Dose 2 | 6 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Dose 2 | 16 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Dose 2 | 5 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Dose 2 | 5 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Across doses | 5 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Across doses | 77 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Across doses | 65 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Across doses | 5 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Across doses | 170 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Across doses | 115 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Across doses | 20 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Across doses | 44 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Across doses | 92 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Across doses | 5 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Across doses | 140 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Across doses | 9 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Across doses | 107 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Across doses | 42 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Across doses | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Across doses | 27 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Across doses | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Across doses | 13 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Dose 1 | 33 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Dose 1 | 45 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Dose 2 | 8 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Dose 1 | 28 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Across doses | 68 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Dose 1 | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Dose 2 | 2 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Dose 2 | 4 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Dose 1 | 63 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Across doses | 37 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Dose 2 | 11 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Across doses | 106 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Dose 1 | 5 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Across doses | 27 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Across doses | 7 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Dose 1 | 108 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Dose 1 | 21 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Across doses | 57 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Dose 1 | 15 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Dose 1 | 67 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Across doses | 72 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Dose 1 | 4 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Across doses | 2 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Across doses | 6 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Dose 1 | 49 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Across doses | 28 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Dose 1 | 42 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Across doses | 7 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Across doses | 158 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Fatigue, Dose 1 | 5 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Across doses | 6 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Across doses | 19 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Across doses | 12 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Across doses | 95 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Dose 1 | 6 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Across doses | 17 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Across doses | 1 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Temperature, Dose 2 | 19 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Across doses | 44 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Gastro.sympt., Dose 2 | 17 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Headache, Dose 2 | 75 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Gastro.sympt., Dose 2 | 2 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Dose 2 | 46 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Headache, Dose 2 | 45 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Dose 1 | 2 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Fatigue, Dose 2 | 26 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Across doses | 61 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Dose 2 | 1 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Dose 2 | 48 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Joint pain at other location, Dose 2 | 23 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Dose 2 | 13 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Joint pain at other location, Across doses | 37 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Fatigue, Dose 1 | 81 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Joint pain at other location, Across doses | 1 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Dose 2 | 1 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Temperature, Dose 1 | 10 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Across doses | 2 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Dose 2 | 35 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Muscle aches, Dose 1 | 44 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Muscle aches, Across doses | 98 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Dose 2 | 10 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Temperature, Dose 1 | 4 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Shivering, Dose 1 | 18 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Sweating, Dose 1 | 13 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Related Shivering, Dose 2 | 7 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Gastro.sympt., Dose 2 | 33 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Any Sweating, Dose 2 | 20 Participants |
| GSK2340273A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years | Grade 3 Sweating, Dose 1 | 2 Participants |
Secondary
Number of Subjects With Any Medically-attended Adverse 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: Up to Day 385
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 1189 Participants |
| Arepanrix 1D Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 1173 Participants |
| GSK2340273A Group | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | 1190 Participants |
Secondary
Number of Subjects With Any 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.
Time frame: From Day 0 to Day 42
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 913 Participants |
| Arepanrix 1D Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 904 Participants |
| GSK2340273A Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 895 Participants |
Secondary
Number of Subjects With at Least One Pneumonia Event
Time frame: From 14 days after first vaccination until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With at Least One Pneumonia Event | 16 Participants |
| Arepanrix 1D Group | Number of Subjects With at Least One Pneumonia Event | 13 Participants |
| GSK2340273A Group | Number of Subjects With at Least One Pneumonia Event | 20 Participants |
Secondary
Number of Subjects With at Least One Pneumonia Event
Time frame: From 42 days after first vaccination until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With at Least One Pneumonia Event | 16 Participants |
| Arepanrix 1D Group | Number of Subjects With at Least One Pneumonia Event | 12 Participants |
| GSK2340273A Group | Number of Subjects With at Least One Pneumonia Event | 18 Participants |
Secondary
Number of Subjects With at Least One Pneumonia Event
Time frame: From Day 0 after first vaccination until study conclusion on Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With at Least One Pneumonia Event | 16 Participants |
| Arepanrix 1D Group | Number of Subjects With at Least One Pneumonia Event | 15 Participants |
| GSK2340273A Group | Number of Subjects With at Least One Pneumonia Event | 22 Participants |
Secondary
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Time frame: From 42 days after first vaccination until study conclusion at Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
| GSK2340273A Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
Secondary
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Time frame: From 14 days after first vaccination until study conclusion at Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
| GSK2340273A Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
Secondary
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Time frame: From Day 0 after first vaccination until study conclusion at Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
| Arepanrix 1D Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
| GSK2340273A Group | Number of Subjects With at Least One Pneumonia Event | 0 Participants |
Secondary
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.
Time frame: From Day 14 until study end at Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Diarrhea | 1 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Sore throat | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Chills | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fatigue | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Muscle aches all over body | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Cough | 3 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Runny or stuffy nose | 3 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Short of breath | 1 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Headache | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Vomiting | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fever | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Muscle aches all over body | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Diarrhea | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fever | 6 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Sore throat | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Vomiting | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Headache | 4 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Cough | 6 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Short of breath | 1 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Chills | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Runny or stuffy nose | 6 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fatigue | 3 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Short of breath | 2 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fatigue | 4 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fever | 11 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Muscle aches all over body | 4 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Cough | 11 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Sore throat | 6 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Headache | 7 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Runny or stuffy nose | 10 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Vomiting | 4 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Diarrhea | 2 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Chills | 5 Participants |
Secondary
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.
Time frame: From Day 0 until study end at Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Muscle aches all over body | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Vomiting | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fever | 4 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Headache | 0 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Short of breath | 1 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Runny or stuffy nose | 4 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Chills | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Cough | 4 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fatigue | 2 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Diarrhea | 1 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Sore throat | 1 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Short of breath | 1 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fever | 7 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Muscle aches all over body | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Cough | 7 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Sore throat | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Runny or stuffy nose | 7 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Headache | 5 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Vomiting | 2 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Diarrhea | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Chills | 3 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fatigue | 4 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Chills | 5 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Vomiting | 4 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Cough | 11 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fever | 11 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Diarrhea | 2 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Muscle aches all over body | 4 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Short of breath | 2 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Runny or stuffy nose | 10 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Fatigue | 4 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Headache | 7 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases | Sore throat | 6 Participants |
Secondary
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.
Time frame: From Day 14 until study end at Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Vomiting | 302 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Runny or stuffy nose | 656 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Chills | 278 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Headache | 348 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Short of breath | 225 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fever | 716 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Cough | 643 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Muscle aches all over body | 264 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Diarrhea | 124 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Sore throat | 382 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fatigue | 340 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Short of breath | 218 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fever | 659 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Muscle aches all over body | 210 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Cough | 599 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Sore throat | 351 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Runny or stuffy nose | 605 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Headache | 329 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Vomiting | 254 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Diarrhea | 137 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Chills | 255 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fatigue | 302 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Chills | 266 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Vomiting | 291 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Cough | 614 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fever | 677 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Diarrhea | 157 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Muscle aches all over body | 227 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Short of breath | 214 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Runny or stuffy nose | 627 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fatigue | 314 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Headache | 344 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Sore throat | 360 Participants |
Secondary
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.
Time frame: From Day 0 until study end at Day 385
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fever | 745 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Vomiting | 311 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Cough | 668 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Diarrhea | 132 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Chills | 282 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fatigue | 347 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Sore throat | 395 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Runny or stuffy nose | 682 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Muscle aches all over body | 271 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Short of breath | 236 Participants |
| Arepanrix 2D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Headache | 360 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Headache | 340 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Sore throat | 362 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Vomiting | 265 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Chills | 265 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Short of breath | 227 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Diarrhea | 141 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Runny or stuffy nose | 628 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Cough | 626 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Muscle aches all over body | 219 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fatigue | 314 Participants |
| Arepanrix 1D Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fever | 685 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fatigue | 326 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Fever | 700 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Muscle aches all over body | 239 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Cough | 634 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Sore throat | 379 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Runny or stuffy nose | 649 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Short of breath | 352 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Headache | 422 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Vomiting | 301 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Chills | 272 Participants |
| GSK2340273A Group | Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases | Diarrhea | 160 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: Up to Day 385
Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arepanrix 2D Group | Number of Subjects With Serious Adverse Events (SAEs) | 76 Participants |
| Arepanrix 1D Group | Number of Subjects With Serious Adverse Events (SAEs) | 66 Participants |
| GSK2340273A Group | Number of Subjects With Serious Adverse Events (SAEs) | 68 Participants |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Time frame: At Day 385
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix 2D Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 26.6 Fold change |
| Arepanrix 1D Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 13.7 Fold change |
| GSK2340273A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 8.5 Fold change |
| Arepanrix 1D 6M-3Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 6.3 Fold change |
| Arepanrix 1D 3Y-6Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 3.7 Fold change |
| Arepanrix 1D 6Y-10Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 6.1 Fold change |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0.
Time frame: At Day 42
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix 2D Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 140.8 Fold change |
| Arepanrix 1D Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 79.9 Fold change |
| GSK2340273A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 23.4 Fold change |
| Arepanrix 1D 6M-3Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 20.3 Fold change |
| Arepanrix 1D 3Y-6Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 15.6 Fold change |
| Arepanrix 1D 6Y-10Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 29.9 Fold change |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Time frame: At Day 182
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arepanrix 2D Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 24.0 Fold change |
| Arepanrix 1D Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 18.4 Fold change |
| GSK2340273A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 8.0 Fold change |
| Arepanrix 1D 6M-3Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 6.1 Fold change |
| Arepanrix 1D 3Y-6Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 4.8 Fold change |
| Arepanrix 1D 6Y-10Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | 8.5 Fold change |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Titers are presented as geometric mean titers (GMTs).
Time frame: At Days 0 and 182
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix 2D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 0 | 12.62 Titers |
| Arepanrix 2D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 182 | 287.22 Titers |
| Arepanrix 1D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 0 | 11.79 Titers |
| Arepanrix 1D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 182 | 238.25 Titers |
| GSK2340273A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 0 | 9.77 Titers |
| GSK2340273A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 182 | 76.52 Titers |
| Arepanrix 1D 6M-3Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 0 | 17.57 Titers |
| Arepanrix 1D 6M-3Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 182 | 108.59 Titers |
| Arepanrix 1D 3Y-6Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 0 | 14.22 Titers |
| Arepanrix 1D 3Y-6Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 182 | 74.94 Titers |
| Arepanrix 1D 6Y-10Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 0 | 12.19 Titers |
| Arepanrix 1D 6Y-10Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) | Day 182 | 145.06 Titers |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Titers are presented as geometric mean titers (GMTs).
Time frame: At Days 0 and 42
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with both doses of study vaccine/placebo administered per protocol treatment assignment and assay results for antibodies against A/California at the relevant timepoints were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix 2D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 1738.90 Titers |
| Arepanrix 2D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 12.40 Titers |
| Arepanrix 1D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 1345.36 Titers |
| Arepanrix 1D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 16.92 Titers |
| GSK2340273A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 11.19 Titers |
| GSK2340273A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 258.02 Titers |
| Arepanrix 1D 6M-3Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 14.17 Titers |
| Arepanrix 1D 6M-3Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 279.52 Titers |
| Arepanrix 1D 3Y-6Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 12.25 Titers |
| Arepanrix 1D 3Y-6Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 188.89 Titers |
| Arepanrix 1D 6Y-10Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 42 | 443.98 Titers |
| Arepanrix 1D 6Y-10Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 14.76 Titers |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Titers are presented as geometric mean titers (GMTs).
Time frame: At Days 0 and 385
Population: The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arepanrix 2D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 265.61 Titers |
| Arepanrix 2D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 9.62 Titers |
| Arepanrix 1D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 189.44 Titers |
| Arepanrix 1D Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 15.71 Titers |
| GSK2340273A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 112.56 Titers |
| GSK2340273A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 9.93 Titers |
| Arepanrix 1D 6M-3Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 14.92 Titers |
| Arepanrix 1D 6M-3Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 103.57 Titers |
| Arepanrix 1D 3Y-6Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 10.13 Titers |
| Arepanrix 1D 3Y-6Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 54.90 Titers |
| Arepanrix 1D 6Y-10Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 0 | 13.57 Titers |
| Arepanrix 1D 6Y-10Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain | Day 385 | 92.33 Titers |