Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age
Official Title
A Study to Evaluate the Safety and Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children Aged 6 Months to Less Than 10 Years of Age
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Feb 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 12, 2010Actual
Primary Completion Date
Aug 31, 2011Actual
Completion Date
Sep 9, 2011Actual
First Submitted Date
Jan 14, 2010
First Submission Date that Met QC Criteria
Jan 14, 2010
First Posted Date
Jan 18, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 25, 2017
Results First Submitted that Met QC Criteria
Apr 30, 2020
Results First Posted Date
May 13, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 10, 2011
Certification/Extension First Submitted that Passed QC Review
Nov 10, 2011
Certification/Extension First Posted Date
Nov 16, 2011Estimated
Last Update Submitted Date
Feb 3, 2021
Last Update Posted Date
Feb 26, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Influenza
H1N1
Pandemic
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
6,154Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arepanrix 2D 6M-3Y Group
Experimental
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
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).
From 14 days after first vaccination until study conclusion on Day 385
Secondary Outcomes
Measure
Description
Time Frame
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).
From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One A/California Influenza Event
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
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.
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).
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
From Day 0 until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
From 14 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
From Day 0 until study conclusion on Day 385
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 at Least One Pneumonia Event
From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
From Day 0 after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
From 14 days after first vaccination until study conclusion at Day 385
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
From 42 days after first vaccination until study conclusion at Day 385
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
From Day 0 after first vaccination until study conclusion at Day 385
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.
From Day 0 until study end at Day 385
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.
From Day 14 until study end at Day 385
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.
From Day 0 until study end at Day 385
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.
From Day 14 until study end at Day 385
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.
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
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.
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
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.
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
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.
Up to Day 385
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.
Up to Day 385
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.
From Day 0 to Day 42
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.
Up to Day 385
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Titers are presented as geometric mean titers (GMTs).
At Days 0 and 42
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.
At Days 0 and 42
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.
At Day 42
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.
At Days 0 and 42
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.
At Day 42
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.
At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Titers are presented as geometric mean titers (GMTs).
At Days 0 and 182
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.
At Days 0 and 182
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.
At Day 182
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.
At Days 0 and 182
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.
At Day 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Titers are presented as geometric mean titers (GMTs).
At Days 0 and 385
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.
At Days 0 and 385
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.
At Day 385
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.
At Days 0 and 385
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.
Taylor S, Lopez P, Weckx L, Borja-Tabora C, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Angel Rodriguez Weber M, Mascarenas de Los Santos A, Tinoco JC, Safadi MA, Lim FS, Hernandez-de Mezerville M, Faingezicht I, Cruz-Valdez A, Feng Y, Li P, Durviaux S, Haars G, Roy-Ghanta S, Vaughn DW, Nolan T. Respiratory viruses and influenza-like illness: Epidemiology and outcomes in children aged 6 months to 10 years in a multi-country population sample. J Infect. 2017 Jan;74(1):29-41. doi: 10.1016/j.jinf.2016.09.003. Epub 2016 Sep 22.
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
FG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
FG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
FG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
FG004
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.
FG005
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).
FG000610 subjects
FG0011438 subjects
FG002612 subjects
FG0031436 subjects
FG004613 subjects
FG0051436 subjects
COMPLETED
FG000576 subjects
FG0011375 subjects
FG002573 subjects
FG0031380 subjects
FG004578 subjects
FG0051369 subjects
NOT COMPLETED
FG00034 subjects
FG00163 subjects
FG00239 subjects
FG00356 subjects
FG00435 subjects
FG00567 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG00013 subjects
FG00122 subjects
FG00215 subjects
FG00317 subjects
FG004
Migrated/moved from study area
FG0001 subjects
FG0016 subjects
FG0026 subjects
FG0038 subjects
FG004
Refused blood sampling
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Data not reliable
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Unable to attend visit(s)
FG0002 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG004
Consent not received from both parents
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Failure to comply with protocol
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Subject lost legal representation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG00016 subjects
FG00130 subjects
FG00213 subjects
FG00328 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
BG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
BG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
BG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
BG004
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.
BG005
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).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000610
BG0011438
BG002612
BG0031436
BG004613
BG0051436
BG0066145
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG00021.0± 8.8
BG00173.4± 23.8
BG00221.2± 8.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000291
BG001688
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
African Heritage/African American
Title
Measurements
BG0008
BG00122
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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).
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.
Posted
Count of Participants
Participants
From 14 days after first vaccination until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0003
OG0017
OG00213
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Evaluation of the relative protective efficacy of 2 doses of Arepanrixâ„¢ 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.
Vaccine efficacy increase
76.70
2-Sided
95
18.53
93.39
Superiority
The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was > -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was >0.
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).
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.
Posted
Count of Participants
Participants
From 42 days after first vaccination until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
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).
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.
Posted
Count of Participants
Participants
From Day 0 until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
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.
Posted
Count of Participants
Participants
From 14 days after first vaccination until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
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.
Posted
Count of Participants
Participants
From 42 days after first vaccination until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
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.
Posted
Count of Participants
Participants
From Day 0 until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects With at Least One Pneumonia Event
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.
Posted
Count of Participants
Participants
From 14 days after first vaccination until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects With at Least One Pneumonia Event
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.
Posted
Count of Participants
Participants
From 42 days after first vaccination until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects With at Least One Pneumonia Event
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.
Posted
Count of Participants
Participants
From Day 0 after first vaccination until study conclusion on Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
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.
Posted
Count of Participants
Participants
From 14 days after first vaccination until study conclusion at Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
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.
Posted
Count of Participants
Participants
From 42 days after first vaccination until study conclusion at Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Secondary
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
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.
Posted
Count of Participants
Participants
From Day 0 after first vaccination until study conclusion at Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
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.
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.
Posted
Count of Participants
Participants
From Day 0 until study end at Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
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.
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.
Posted
Count of Participants
Participants
From Day 14 until study end at Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
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.
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.
Posted
Count of Participants
Participants
From Day 0 until study end at Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
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.
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.
Posted
Count of Participants
Participants
From Day 14 until study end at Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
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.
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.
Posted
Count of Participants
Participants
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-6Y Group
Subjects, male and female, aged 3 years (Y) to less than (<) 6 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
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.
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.
Posted
Count of Participants
Participants
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
ID
Title
Description
OG000
Arepanrix 2D 6Y-10Y Group
Subjects, male and female, aged 6 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
OG001
Arepanrix 1D 6Y-10Y Group
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.
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.
Posted
Count of Participants
Participants
Up to Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
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.
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.
Posted
Count of Participants
Participants
Up to Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
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.
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.
Posted
Count of Participants
Participants
From Day 0 to Day 42
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
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.
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.
Posted
Count of Participants
Participants
Up to Day 385
ID
Title
Description
OG000
Arepanrix 2D Group
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
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).
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Days 0 and 42
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Days 0 and 42
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Day 42
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Days 0 and 42
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
Fold change
At Day 42
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Number
Adjusted GMT ratio
At Day 42
ID
Title
Description
OG000
Arepanrix 1D Group
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG001
Arepanrix 2D Group
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Titers are presented as geometric mean titers (GMTs).
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Days 0 and 182
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Days 0 and 182
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Day 182
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Days 0 and 182
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
Fold change
At Day 182
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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).
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Days 0 and 385
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Days 0 and 385
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Day 385
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Count of Participants
Participants
At Days 0 and 385
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
Fold change
At Day 385
ID
Title
Description
OG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
OG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
Time Frame
Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arepanrix 2D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrixâ„¢ 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.
1
610
35
610
498
610
EG001
Arepanrix 2D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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
1,438
41
1,438
1,116
1,438
EG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
1
612
29
612
439
612
EG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
0
1,436
37
1,436
1,047
1,436
EG004
GSK2340273A 6M-3Y Group
Subjects, male and female, aged 6 months to 3 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) 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.
0
613
33
613
446
613
EG005
GSK2340273A 3Y-10Y Group
Subjects, male and female, aged 3 years 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).
0
1,436
35
1,436
891
1,436
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Idiopathic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG0030 events0 affected1,436 at risk
EG004
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Rectal fissure
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Tongue disorder
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Drowning
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Influenza like illness
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Adenoiditis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Amoebiasis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0015 events5 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Ascariasis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0022 events1 affected612 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0022 events1 affected612 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0008 events7 affected610 at risk
EG0013 events3 affected1,438 at risk
EG0027 events7 affected612 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Hepatitis a
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Hepatitis viral
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Influenza
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Meningitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Otitis media
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Parasitic gastroenteritis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0006 events6 affected610 at risk
EG0013 events3 affected1,438 at risk
EG0028 events7 affected612 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Typhoid fever
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0014 events4 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Varicella
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Viral infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0012 events2 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Mechanical ventilation complication
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0002 events2 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Osteosclerosis
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0022 events2 affected612 at risk
EG003
Guillain-barre syndrome
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Vaginal laceration
Reproductive system and breast disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0012 events2 affected1,438 at risk
EG0023 events3 affected612 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 events1 affected610 at risk
EG0014 events3 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0021 events1 affected612 at risk
EG003
Nasal septum disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Urticaria chronic
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Sexual abuse
Social circumstances
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Extremity necrosis
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0011 events1 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Subgaleal haematoma
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG0010 events0 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG001125 events103 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003101 events92 affected1,436 at risk
EG0042 events1 affected613 at risk
EG00569 events61 affected1,436 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG000222 events182 affected610 at risk
EG001204 events171 affected1,438 at risk
EG002151 events127 affected612 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG001180 events140 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG00177 events68 affected1,438 at risk
EG0022 events2 affected612 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0004 events4 affected610 at risk
EG001321 events254 affected1,438 at risk
EG0024 events4 affected612 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG000313 events237 affected610 at risk
EG001196 events162 affected1,438 at risk
EG002209 events164 affected612 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected610 at risk
EG001211 events166 affected1,438 at risk
EG0020 events0 affected612 at risk
EG003
Pain
General disorders
MedDRA 15.0
Systematic Assessment
EG000417 events288 affected610 at risk
EG0011,476 events941 affected1,438 at risk
EG002294 events222 affected612 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Systematic Assessment
EG000272 events230 affected610 at risk
EG001279 events256 affected1,438 at risk
EG002166 events151 affected612 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG000220 events175 affected610 at risk
EG001195 events160 affected1,438 at risk
EG002146 events124 affected612 at risk
EG003
Swelling
General disorders
MedDRA 15.0
Systematic Assessment
EG00035 events31 affected610 at risk
EG00195 events80 affected1,438 at risk
EG00218 events17 affected612 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG00067 events61 affected610 at risk
EG001100 events88 affected1,438 at risk
EG00253 events47 affected612 at risk
EG003
Diarrohoea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG00036 events33 affected610 at risk
EG00123 events23 affected1,438 at risk
EG00226 events24 affected612 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG000110 events99 affected610 at risk
EG001120 events112 affected1,438 at risk
EG00290 events82 affected612 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG000135 events120 affected610 at risk
EG001148 events132 affected1,438 at risk
EG002129 events119 affected612 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
GSKClinicalSupportHD@gsk.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C568072
arepanrix
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
10 subjects
FG00524 subjects
7 subjects
FG0053 subjects
0 subjects
FG0051 subjects
0 subjects
FG0051 subjects
3 subjects
FG0052 subjects
0 subjects
FG0051 subjects
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
2 subjects
FG0051 subjects
12 subjects
FG00534 subjects
73.2
± 24.2
BG00421.2± 8.6
BG00573.2± 24.3
BG00657.7± 31.6
308
BG003748
BG004291
BG005732
BG0063058
Male
BG000319
BG001750
BG002304
BG003688
BG004322
BG005704
BG0063087
4
BG00322
BG0043
BG00526
BG00685
Asian-Central/South Asian Heritage
Title
Measurements
BG0000
BG0011
BG0021
BG0030
BG0040
BG0052
BG0064
Asian-East Asian Heritage
Title
Measurements
BG0001
BG0011
BG0020
BG0032
BG0041
BG0057
BG00612
Asian-Japanese Heritage
Title
Measurements
BG0001
BG0012
BG0020
BG0033
BG0040
BG0052
BG0068
Asian-South East Asian Heritage
Title
Measurements
BG000297
BG001507
BG002301
BG003503
BG004297
BG005499
BG0062404
Native Hawaiian or other Pacific islander
Title
Measurements
BG0000
BG0012
BG0021
BG0030
BG0040
BG0051
BG0064
White-Arabic/North African Heritage
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0061
White-Caucasian/European Heritage
Title
Measurements
BG00068
BG001172
BG00259
BG003161
BG00468
BG005165
BG006693
Other
Title
Measurements
BG000235
BG001731
BG002246
BG003745
BG004243
BG005734
BG0062934
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0003
OG0015
OG0029
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0004
OG0019
OG00213
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0002
OG0016
OG0028
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0025
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0003
OG0017
OG0028
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG00016
OG00113
OG00220
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG00016
OG00112
OG00218
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG00016
OG00115
OG00222
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001940
OG0011933
OG0021930
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001903
OG0011913
OG0021897
Title
Denominators
Categories
Fever
Title
Measurements
OG000745
OG001685
OG002700
Muscle aches all over body
Title
Measurements
OG000271
OG001219
OG002239
Cough
Title
Measurements
OG000668
OG001626
OG002634
Sore throat
Title
Measurements
OG000395
OG001362
OG002379
Runny or stuffy nose
Title
Measurements
OG000682
OG001628
OG002649
Short of breath
Title
Measurements
OG000236
OG001227
OG002352
Headache
Title
Measurements
OG000360
OG001340
OG002422
Vomiting
Title
Measurements
OG000311
OG001265
OG002301
Diarrhea
Title
Measurements
OG000132
OG001141
OG002160
Chills
Title
Measurements
OG000282
OG001265
OG002272
Fatigue
Title
Measurements
OG000347
OG001314
OG002326
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001903
OG0011913
OG0021897
Title
Denominators
Categories
Fever
Title
Measurements
OG000716
OG001659
OG002677
Muscle aches all over body
Title
Measurements
OG000264
OG001210
OG002227
Cough
Title
Measurements
OG000643
OG001599
OG002614
Sore throat
Title
Measurements
OG000382
OG001351
OG002360
Runny or stuffy nose
Title
Measurements
OG000656
OG001605
OG002627
Short of breath
Title
Measurements
OG000225
OG001218
OG002214
Headache
Title
Measurements
OG000348
OG001329
OG002344
Vomiting
Title
Measurements
OG000302
OG001254
OG002291
Diarrhea
Title
Measurements
OG000124
OG001137
OG002157
Chills
Title
Measurements
OG000278
OG001255
OG002266
Fatigue
Title
Measurements
OG000340
OG001302
OG002314
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001903
OG0011913
OG0021897
Title
Denominators
Categories
Fever
Title
Measurements
OG0004
OG0017
OG00211
Muscle aches all over body
Title
Measurements
OG0000
OG0012
OG0024
Cough
Title
Measurements
OG0004
OG0017
OG00211
Sore throat
Title
Measurements
OG0001
OG0013
OG0026
Runny or stuffy nose
Title
Measurements
OG0004
OG0017
OG00210
Short of breath
Title
Measurements
OG0001
OG0011
OG0022
Headache
Title
Measurements
OG0000
OG0015
OG0027
Vomiting
Title
Measurements
OG0002
OG0012
OG0024
Diarrhea
Title
Measurements
OG0001
OG0013
OG0022
Chills
Title
Measurements
OG0002
OG0013
OG0025
Fatigue
Title
Measurements
OG0002
OG0014
OG0024
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0001903
OG0011913
OG0021897
Title
Denominators
Categories
Fever
Title
Measurements
OG0003
OG0016
OG00211
Muscle aches all over body
Title
Measurements
OG0000
OG0012
OG0024
Cough
Title
Measurements
OG0003
OG0016
OG00211
Sore throat
Title
Measurements
OG0000
OG0013
OG0026
Runny or stuffy nose
Title
Measurements
OG0003
OG0016
OG00210
Short of breath
Title
Measurements
OG0001
OG0011
OG0022
Headache
Title
Measurements
OG0000
OG0014
OG0027
Vomiting
Title
Measurements
OG0002
OG0012
OG0024
Diarrhea
Title
Measurements
OG0001
OG0013
OG0022
Chills
Title
Measurements
OG0002
OG0013
OG0025
Fatigue
Title
Measurements
OG0002
OG0013
OG0024
OG002
Arepanrix 2D 6Y-10Y Group
Subjects, male and female, aged 6 years (Y) to less than (<) 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
OG003
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG004
Arepanrix 1D 3Y-6Y Group
Subjects, male and female, aged 3 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG005
Arepanrix 1D 6Y-10Y Group
Subjects, male and female, aged 6 years (Y) to less than (<) 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG006
GSK2340273A 6M-3Y Group
Subjects, male and female, aged 6 months (M) to less than (<) 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.
OG007
GSK2340273A 3Y-6Y Group
Subjects, male and female, aged 2 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG008
GSK2340273A 6Y-10Y Group
Subjects, male and female, aged 6 years (Y) to less than (<) 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).
Units
Counts
Participants
OG000610
OG001726
OG002712
OG003612
OG004744
OG005692
OG006613
OG007714
OG008722
Title
Denominators
Categories
Any Pain, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
ParticipantsOG004744
ParticipantsOG005692
ParticipantsOG006613
ParticipantsOG007714
ParticipantsOG008722
Title
Measurements
OG000204
OG001369
OG002416
OG003
Grade 3 Pain, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Any Redness, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Grade 3 Redness, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Any Swelling, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Grade 3 Swelling, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Any Pain, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002699
ParticipantsOG003591
Grade 3 Pain, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002699
ParticipantsOG003591
Any Redness, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002699
ParticipantsOG003591
Grade 3 Redness, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002699
ParticipantsOG003591
Any Swelling, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002699
ParticipantsOG003591
Grade 3 Swelling, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002699
ParticipantsOG003591
Any Pain, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Grade 3 Pain, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Any Redness, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Grade 3 Redness, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Any Swelling, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
Grade 3 Swelling, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002712
ParticipantsOG003612
OG001
Arepanrix 2D 3Y-6Y Group
Subjects, male and female, aged 3 years (Y) to less than (<) 6 years, received 2 doses (D) of the Arepanrixâ„¢ 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).
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to less than (<) 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-6Y Group
Subjects, male and female, aged 3 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
GSK2340273A 6M-3Y Group
Subjects, male and female, aged 6 months (M) to less than (<) 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.
OG005
GSK2340273A 3Y-6Y Group
Subjects, male and female, aged 2 years (Y) to less than (<) 6 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
Units
Counts
Participants
OG000610
OG001726
OG002612
OG003744
OG004613
OG005714
Title
Denominators
Categories
Any Drowsiness, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
ParticipantsOG004613
ParticipantsOG005714
Title
Measurements
OG000105
OG001103
OG00293
OG003
Grade 3 Drowsiness, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Drowsiness, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Any Irritability, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Grade 3 Irritability, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Irritability, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Any Loss of appetite, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Grade 3 Loss of appetite, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Loss of appetite, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Any Temperature, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Grade 3 Temperature, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Temperature, Dose 1
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Any Drowsiness, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Grade 3 Drowsiness, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Related Drowsiness, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Any Irritability, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Grade 3 Irritability, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Related Irritability, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Any Loss of appetite, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Grade 3 Loss of appetite, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Related Loss of appetite, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Any Temperature, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Grade 3 Temperature, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Related Temperature, Dose 2
ParticipantsOG000592
ParticipantsOG001708
ParticipantsOG002591
ParticipantsOG003727
Any Drowsiness, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Grade 3 Drowsiness, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Drowsiness, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Any Irritability, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Grade 3 Irritability, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Irritability, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Any Loss of appetite, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Grade 3 Loss of appetite, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Loss of appetite, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Any Temperature, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Grade 3 Temperature, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Related Temperature, Across doses
ParticipantsOG000610
ParticipantsOG001726
ParticipantsOG002612
ParticipantsOG003744
Subjects, male and female, aged 6 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG002
GSK2340273A 6Y-10Y Group
Subjects, male and female, aged 6 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).
Units
Counts
Participants
OG000712
OG001692
OG002722
Title
Denominators
Categories
Any Fatigue, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG00090
OG00182
OG00281
Grade 3 Fatigue, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Fatigue, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Gastro.sympt., Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Gastro.sympt., Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Gastro.sympt., Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Headache, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Headache, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Headache, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Joint pain at other location, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Joint pain at other location, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Joint pain at other location, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Muscle aches, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Muscle aches, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Muscle aches, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Shivering, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Shivering, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Shivering, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Sweating, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Sweating, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Sweating, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Temperature, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Temperature, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Temperature, Dose 1
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Fatigue, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Fatigue, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Fatigue, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Gastro.sympt., Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Gastro.sympt., Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Gastro.sympt., Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Headache, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Headache, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Headache, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Joint pain at other location, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Joint pain at other location, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Joint pain at other location, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Muscle aches, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Muscle aches, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Muscle aches, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Shivering, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Shivering, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Shivering, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Sweating, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Sweating, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Sweating, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Temperature, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Grade 3 Temperature, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Related Temperature, Dose 2
ParticipantsOG000699
ParticipantsOG001681
ParticipantsOG002709
Title
Measurements
OG000
Any Fatigue, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Fatigue, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Fatigue, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Gastro.sympt., Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Gastro.sympt., Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Gastro.sympt., Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Headache, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Headache, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Headache, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Joint pain at other location, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Joint pain at other location, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Joint pain at other location, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Muscle aches, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Muscle aches, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Muscle aches, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Shivering, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Shivering, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Shivering, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Sweating, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Sweating, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Sweating, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Any Temperature, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Grade 3 Temperature, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
Related Temperature, Across doses
ParticipantsOG000712
ParticipantsOG001692
ParticipantsOG002722
Title
Measurements
OG000
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0002048
OG0012048
OG0022049
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0023
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0002048
OG0012048
OG0022049
Title
Denominators
Categories
Title
Measurements
OG0001189
OG0011173
OG0021190
Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0002048
OG0012048
OG0022049
Title
Denominators
Categories
Title
Measurements
OG000913
OG001904
OG002895
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG0002048
OG0012048
OG0022049
Title
Denominators
Categories
Title
Measurements
OG00076
OG00166
OG00268
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000233
OG001167
OG002232
OG003156
OG004223
OG005164
Title
Denominators
Categories
Day 0
ParticipantsOG000229
ParticipantsOG001166
ParticipantsOG002228
ParticipantsOG003153
ParticipantsOG004220
ParticipantsOG005161
Title
Measurements
OG00012.40(10.21 to 15.06)
OG00116.92(13.77 to 20.80)
OG00211.19(9.32 to 13.43)
OG003
Day 42
ParticipantsOG000233
ParticipantsOG001167
ParticipantsOG002232
ParticipantsOG003156
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000233
OG001167
OG002232
OG003156
OG004223
OG005164
Title
Denominators
Categories
Day 0
ParticipantsOG000229
ParticipantsOG001166
ParticipantsOG002228
ParticipantsOG003153
ParticipantsOG004220
ParticipantsOG005161
Title
Measurements
OG00066
OG00182
OG00262
OG003
Day 42
ParticipantsOG000233
ParticipantsOG001167
ParticipantsOG002232
ParticipantsOG003156
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000229
OG001166
OG002228
OG003153
OG004220
OG005161
Title
Denominators
Categories
Title
Measurements
OG000228
OG001166
OG002224
OG003149
OG004187
OG005155
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000233
OG001167
OG002232
OG003156
OG004223
OG005164
Title
Denominators
Categories
Day 0
ParticipantsOG000229
ParticipantsOG001166
ParticipantsOG002228
ParticipantsOG003153
ParticipantsOG004220
ParticipantsOG005161
Title
Measurements
OG00061
OG00166
OG00255
OG003
Day 42
ParticipantsOG000233
ParticipantsOG001167
ParticipantsOG002232
ParticipantsOG003156
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000229
OG001166
OG002228
OG003153
OG004220
OG005161
Title
Denominators
Categories
Title
Measurements
OG000140.8(116.6 to 170.0)
OG00179.9(65.3 to 97.6)
OG00223.4(21.2 to 25.7)
OG00320.3(17.7 to 23.3)
OG00415.6(13.5 to 18.0)
OG00529.9(25.1 to 35.7)
Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrixâ„¢ 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
OG002
GSK2340273A Group
Subjects, male and female, aged 6 months 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) 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. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.
Units
Counts
Participants
OG000381
OG001395
OG002381
Title
Denominators
Categories
Title
Measurements
OG000278.9
OG0011548.5
OG002275.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
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).
Adjusted GMT ratios
5.61
2-Sided
95
4.92
6.41
Other
OG000
OG002
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).
Adjusted GMT ratios
1.05
2-Sided
95
0.93
1.19
Other
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000186
OG001378
OG002177
OG003389
OG004184
OG005379
Title
Denominators
Categories
Day 0
ParticipantsOG00070
ParticipantsOG00140
ParticipantsOG00275
ParticipantsOG00351
ParticipantsOG00461
ParticipantsOG00549
Title
Measurements
OG00012.62(8.79 to 18.12)
OG00111.79(7.90 to 17.60)
OG0029.77(7.23 to 13.22)
OG003
Day 182
ParticipantsOG000186
ParticipantsOG001378
ParticipantsOG002177
ParticipantsOG003389
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000186
OG001378
OG002177
OG003389
OG004184
OG005379
Title
Denominators
Categories
Day 0
ParticipantsOG00070
ParticipantsOG00140
ParticipantsOG00275
ParticipantsOG00351
ParticipantsOG00461
ParticipantsOG00549
Title
Measurements
OG00020
OG00115
OG00217
OG003
Day 182
ParticipantsOG000186
ParticipantsOG001378
ParticipantsOG002177
ParticipantsOG003389
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG00070
OG00140
OG00275
OG00351
OG00461
OG00549
Title
Denominators
Categories
Title
Measurements
OG00066
OG00138
OG00254
OG00333
OG00432
OG00534
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000186
OG001378
OG002177
OG003389
OG004184
OG005379
Title
Denominators
Categories
Day 0
ParticipantsOG00070
ParticipantsOG00140
ParticipantsOG00275
ParticipantsOG00351
ParticipantsOG00461
ParticipantsOG00549
Title
Measurements
OG00019
OG00110
OG00216
OG003
Day 182
ParticipantsOG000186
ParticipantsOG001378
ParticipantsOG002177
ParticipantsOG003389
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG00070
OG00140
OG00275
OG00351
OG00461
OG00549
Title
Denominators
Categories
Title
Measurements
OG00024.0(18.5 to 31.1)
OG00118.4(13.1 to 25.8)
OG0028.0(6.8 to 9.3)
OG0036.1(4.7 to 7.9)
OG0044.8(3.7 to 6.3)
OG0058.5(6.4 to 11.4)
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000173
OG001349
OG002163
OG003339
OG004158
OG005344
Title
Denominators
Categories
Day 0
ParticipantsOG00062
ParticipantsOG00133
ParticipantsOG00251
ParticipantsOG00332
ParticipantsOG00455
ParticipantsOG00534
Title
Measurements
OG0009.62(6.76 to 13.69)
OG00115.71(9.76 to 25.27)
OG0029.93(6.71 to 14.71)
OG003
Day 385
ParticipantsOG000173
ParticipantsOG001349
ParticipantsOG002163
ParticipantsOG003339
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000173
OG001349
OG002163
OG003339
OG004158
OG005344
Title
Denominators
Categories
Day 0
ParticipantsOG00062
ParticipantsOG00133
ParticipantsOG00251
ParticipantsOG00332
ParticipantsOG00455
ParticipantsOG00534
Title
Measurements
OG00012
OG00116
OG00211
OG003
Day 385
ParticipantsOG000173
ParticipantsOG001349
ParticipantsOG002163
ParticipantsOG003339
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG00062
OG00133
OG00251
OG00332
OG00455
OG00534
Title
Denominators
Categories
Title
Measurements
OG00058
OG00130
OG00235
OG00317
OG00418
OG00518
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).
Units
Counts
Participants
OG000173
OG001349
OG002163
OG003339
OG004158
OG005344
Title
Denominators
Categories
Day 0
ParticipantsOG00062
ParticipantsOG00133
ParticipantsOG00251
ParticipantsOG00332
ParticipantsOG00455
ParticipantsOG00534
Title
Measurements
OG00011
OG00112
OG00210
OG003
Day 385
ParticipantsOG000173
ParticipantsOG001349
ParticipantsOG002163
ParticipantsOG003339
OG002
Arepanrix 1D 6M-3Y Group
Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrixâ„¢ 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.
OG003
Arepanrix 1D 3Y-10Y Group
Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrixâ„¢ 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).
OG004
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.
OG005
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).