Immunogenicity and Safety Study of Fluarixâ„¢ Vaccine in Ch... | NCT01196026 | Trialant
NCT01196026
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Sep 24, 2018Actual
Enrollment
162Actual
Phase
Phase 4
Conditions
Influenza
Interventions
Fluarixâ„¢
Havrixâ„¢ Junior
Countries
Netherlands
Sweden
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01196026
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
114451
Secondary IDs
Not provided
Brief Title
Immunogenicity and Safety Study of Fluarixâ„¢ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrixâ„¢
Official Title
Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine Fluarixâ„¢ in Children Previously Vaccinated With GSK Biologicals' H1N1 Vaccine Pandemrixâ„¢
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Sep 2016
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
Sep 15, 2010
Primary Completion Date
May 26, 2011Actual
Completion Date
May 26, 2011Actual
First Submitted Date
Sep 3, 2010
First Submission Date that Met QC Criteria
Sep 3, 2010
First Posted Date
Sep 8, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 12, 2012
Results First Submitted that Met QC Criteria
May 24, 2012
Results First Posted Date
Jun 28, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 22, 2018
Last Update Posted Date
Sep 24, 2018Actual
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
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' Fluarix vaccine in children who have previously been vaccinated with two doses of Pandemrix at the age of 6 months-9 years.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Influenza
H1N1
Fluarix
Pandemrix
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 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
162Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Fluarix 6-11 months Group
Experimental
Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine
Biological: Fluarixâ„¢
Fluarix 12-35 months Group
Experimental
Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine
Biological: Fluarixâ„¢
Fluarix 3-9 years Group
Experimental
Subjects previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine
Biological: Fluarixâ„¢
Havrix Junior 6-11 months Group
Active Comparator
Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine
Biological: Havrixâ„¢ Junior
Havrix Junior 12-35 months Group
Active Comparator
Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine
Biological: Havrixâ„¢ Junior
Havrix Junior 3-9 years Group
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fluarixâ„¢
Biological
One or two intramuscular injections
Fluarix 12-35 months Group
Fluarix 3-9 years Group
Fluarix 6-11 months Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Antibody titers were expressed as Geometric mean titers (GMTs).
Day 0 and 28
Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:10.
Day 0-28
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Day 0-28
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Day 28
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Day 28
Secondary Outcomes
Measure
Description
Time Frame
HI Antibody Titers Against All Fluarix Vaccine Strains
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects having previously been immunized with two 0.25 mL doses of Pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination.
Subjects having received the last dose of Pandemrix at least six months prior to study enrolment.
Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/LAR(s) of the subjects.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Exclusion Criteria:
Active participation in other clinical trials.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
Acute disease and/or fever at the time of enrolment.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
History of seizures or progressive neurological disease.
Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.
See Also Links
Label
URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
162 subjects were enrolled in the study but only 154 subjects were vaccinated. The remaining 8 subjects gave their consent withdrawal and were not included in the study.Enrollment was stratified according to the age at first Pandemrix vaccination: 6-11 months, 12-35 months, 3-9 years. Also, subjects were grouped from 3-5 and from 6-9 years.
Recruitment Details
Primed subjects =subjects who had been previously vaccinated with a seasonal influenza vaccine whereas unprimed subjects had not.
children ≥ 9 years + primed children < 9 years=1 dose of Fluarix
unprimed children < 9 years=2 doses of Fluarix. To complete the vaccination schedule, a 2nd dose of Havrix vaccine was given outside the study setting
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
FG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
FG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
FG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
FG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
FG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG00144 subjects
FG00223 subjects
FG00310 subjects
FG00443 subjects
FG00524 subjects
Completed at Day 28
FG0009 subjects
FG00141 subjects
FG00223 subjects
FG00310 subjects
FG004
COMPLETED
FG0009 subjects
FG00136 subjects
FG00223 subjects
FG00310 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0014 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
BG001
Fluarix 12-35 Months Group
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Antibody titers were expressed as Geometric mean titers (GMTs).
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 0 and 28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Adverse Events Module
Frequency Threshold
5
Time Frame
Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
Description
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
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
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C510903
fluarix
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Active Comparator
Subjects previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine
Biological: Havrixâ„¢ Junior
Havrixâ„¢ Junior
Biological
Two intramuscular injections
Havrix Junior 12-35 months Group
Havrix Junior 3-9 years Group
Havrix Junior 6-11 months Group
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Day 0 and Month 6
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Day 0 and Month 6
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Day 28
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Month 6
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Day 0 and Month 6
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Day 28
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Month 6
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Antibody titers were expressed as Geometric Mean Titers (GMTs).
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Day 0 and Month 6
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
Seropositivity was defined as antibody titers greater than or equal to 1:28.
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Day 0 and Month 6
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Day 28
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.
During the 7 days (Day 0 - 6) after vaccination
Duration of Any Solicited Local Symptom
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.
During the 7 days (Days 0 - 6) after vaccination
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
During the 7 days (Days 0-6) after vaccination
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.
During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.
During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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 any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination.
During a 28 day follow-up period (Day 0-27) after vaccination
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis.
During the entire study period (up to Month 6)
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Up to Day 28
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Up to Month 6
Karlskrona
SE-371 41
Sweden
GSK Investigational Site
Malmö
SE-205 02
Sweden
GSK Investigational Site
Örebro
SE-702 11
Sweden
GSK Investigational Site
Skellefteå
SE-931 86
Sweden
GSK Investigational Site
Stockholm
SE-118 83
Sweden
GSK Investigational Site
Umeå
SE-901 85
Sweden
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
42 subjects
FG00524 subjects
42 subjects
FG00524 subjects
1 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
BG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
BG003
Havrix Junior 6-11 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
BG004
Havrix Junior 12-35 Months Group
Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine.
BG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
BG006
Total
Total of all reporting groups
10
BG00144
BG00223
BG00310
BG00443
BG00524
BG006154
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG0001.0± 0.00
BG0012.3± 0.52
BG0026.4± 1.99
BG0031.0± 0.00
BG0042.4± 0.58
BG0057.5± 1.53
BG0063.58± 2.54
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG00121
BG00213
BG0034
BG00416
BG00513
BG00672
Male
BG0005
BG00123
BG00210
BG0036
BG004
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00665
Title
Denominators
Categories
Day 0
Title
Measurements
OG006120.7(100.8 to 144.4)
Day 28
Title
Measurements
OG0061079.3(915.8 to 1272.0)
Primary
Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:10.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Posted
Count of Participants
Participants
Day 0-28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Day 0
Title
Measurements
OG00665
Day 28
Title
Measurements
OG00665
Primary
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Posted
Count of Participants
Participants
Day 0-28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Day 0
Title
Measurements
OG00663
Day 28
Title
Measurements
OG00665
Primary
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Posted
Count of Participants
Participants
Day 28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG00655
Primary
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0068.9(7.1 to 11.2)
Secondary
HI Antibody Titers Against All Fluarix Vaccine Strains
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Posted
Mean
95% Confidence Interval
titer
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00135
OG00223
OG003
Title
Denominators
Categories
H1N1 Day 0
Title
Measurements
OG000176.6(79.3 to 393.4)
OG001124.9(97.1 to 160.5)
OG002102.0(77.2 to 134.9)
OG003
Secondary
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 0 and Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1 Day 0
Title
Measurements
OG000201.6(81.1 to 501.1)
OG001126.4(93.2 to 171.4)
OG00296.9(73.9 to 126.9)
OG003
Secondary
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Posted
Count of Participants
Participants
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00135
OG00223
OG003
Title
Denominators
Categories
H1N1 Day 0
Title
Measurements
OG0007
OG00135
OG00223
OG003
Secondary
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Count of Participants
Participants
Day 0 and Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1 Day 0
Title
Measurements
OG0006
OG00128
OG00222
OG003
Secondary
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Posted
Count of Participants
Participants
Day 28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00135
OG00223
OG003
Title
Denominators
Categories
H1N1
Title
Measurements
OG0005
OG00131
OG00219
OG006
Secondary
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Count of Participants
Participants
Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1
Title
Measurements
OG0005
OG00118
OG00212
OG003
Secondary
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Posted
Count of Participants
Participants
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00135
OG00223
OG003
Title
Denominators
Categories
H1N1 Day 0
Title
Measurements
OG0007
OG00133
OG00223
OG003
Secondary
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Count of Participants
Participants
Day 0 and Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1 Day 0
Title
Measurements
OG0006
OG00126
OG00222
OG003
Secondary
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00135
OG00223
OG003
Title
Denominators
Categories
H1N1
Title
Measurements
OG00010.2(3.0 to 34.8)
OG00110.8(7.9 to 14.7)
OG0026.5(4.7 to 8.8)
OG006
Secondary
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Geometric Mean
95% Confidence Interval
ratio
Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1
Title
Measurements
OG0007.1(2.0 to 25.5)
OG0014.5(3.3 to 6.0)
OG0023.5(2.6 to 4.7)
OG003
Secondary
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Antibody titers were expressed as Geometric Mean Titers (GMTs).
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Posted
Geometric Mean
90% Confidence Interval
titer
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00135
OG00223
OG003
Title
Denominators
Categories
H1N1 Day 0
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG003
Secondary
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 0 and Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1 Day 0
ParticipantsOG0006
ParticipantsOG00127
ParticipantsOG00222
ParticipantsOG003
Secondary
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
Seropositivity was defined as antibody titers greater than or equal to 1:28.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Posted
Count of Participants
Participants
Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00135
OG00223
OG003
Title
Denominators
Categories
H1N1 Day 0
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG003
Secondary
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Count of Participants
Participants
Day 0 and Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1 Day 0
ParticipantsOG0006
ParticipantsOG00127
ParticipantsOG00222
ParticipantsOG003
Secondary
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Posted
Count of Participants
Participants
Day 28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0007
OG00134
OG00223
OG003
Title
Denominators
Categories
H1N1
ParticipantsOG0007
ParticipantsOG00133
ParticipantsOG00223
ParticipantsOG003
Secondary
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Posted
Count of Participants
Participants
Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG006
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
OG007
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Units
Counts
Participants
OG0006
OG00128
OG00222
OG003
Title
Denominators
Categories
H1N1
ParticipantsOG0006
ParticipantsOG00127
ParticipantsOG00222
ParticipantsOG003
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.
The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.
Posted
Count of Participants
Participants
During the 7 days (Day 0 - 6) after vaccination
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG00010
OG00143
OG00223
OG003
Title
Denominators
Categories
Any Pain
Title
Measurements
OG0003
OG00128
OG00221
OG003
Secondary
Duration of Any Solicited Local Symptom
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.
The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.
Posted
Median
Inter-Quartile Range
days
During the 7 days (Days 0 - 6) after vaccination
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG0006
OG00130
OG00220
OG003
Title
Denominators
Categories
Pain [Dose 1]
ParticipantsOG0003
ParticipantsOG00123
ParticipantsOG00220
ParticipantsOG003
Secondary
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.
Posted
Count of Participants
Participants
During the 7 days (Days 0-6) after vaccination
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG00010
OG00143
OG00211
OG003
Title
Denominators
Categories
Any Diarrhoea
Title
Measurements
OG0005
OG0018
OG0022
OG003
Secondary
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.
The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.
Posted
Median
Inter-Quartile Range
days
During a 7-day follow-up period (Day 0-6) after vaccination
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG0005
OG00114
OG0023
OG003
Title
Denominators
Categories
Diarrhoea [Dose 1]
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG003
Secondary
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.
Posted
Count of Participants
Participants
During a 7-day follow-up period (Day 0-6) after vaccination
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG0000
OG0010
OG00212
OG003
Title
Denominators
Categories
Any Arthralgia
Title
Measurements
OG0020
OG0050
Grade 3 Arthralgia
Title
Measurements
OG002
Secondary
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.
The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.
Posted
Median
Inter-Quartile Range
days
During a 7-day follow-up period (Day 0-6) after vaccination
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG0000
OG0010
OG0024
OG003
Title
Denominators
Categories
Fatigue [Dose 1]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG003
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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 any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination.
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Posted
Count of Participants
Participants
During a 28 day follow-up period (Day 0-27) after vaccination
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG00010
OG00144
OG00223
OG003
Title
Denominators
Categories
Any AEs
Title
Measurements
OG0006
OG00120
OG0027
OG003
Secondary
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis.
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Posted
Count of Participants
Participants
During the entire study period (up to Month 6)
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG00010
OG00144
OG00223
OG003
Title
Denominators
Categories
MAEs
Title
Measurements
OG0004
OG00111
OG0022
OG003
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Posted
Count of Participants
Participants
Up to Day 28
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG00010
OG00144
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Posted
Count of Participants
Participants
Up to Month 6
ID
Title
Description
OG000
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
OG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
OG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
Units
Counts
Participants
OG00010
OG00144
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG003
1
10
10
10
EG001
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
1
44
41
44
EG002
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarixâ„¢ vaccine depending on their priming status.
0
23
23
23
EG003
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
0
10
9
10
EG004
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
0
43
34
43
EG005
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrixâ„¢ Junior vaccine.
0
24
20
24
EG0001 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected10 at risk
EG0011 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
EG0003 affected10 at risk
EG00128 affected43 at risk
EG00221 affected23 at risk
EG0035 affected10 at risk
EG00419 affected43 at risk
EG00514 affected24 at risk
Redness
General disorders
Systematic Assessment
EG0007 affected10 at risk
EG00133 affected43 at risk
EG00219 affected23 at risk
EG0032 affected10 at risk
EG00415 affected43 at risk
EG0059 affected24 at risk
Swelling
General disorders
Systematic Assessment
EG0005 affected10 at risk
EG00123 affected43 at risk
EG00211 affected23 at risk
EG0031 affected10 at risk
EG00410 affected43 at risk
EG0055 affected24 at risk
Diarrhoea
General disorders
Systematic Assessment
EG0005 affected10 at risk
EG0018 affected43 at risk
EG0022 affected11 at risk
EG0032 affected10 at risk
EG0047 affected43 at risk
EG0050 affected2 at risk
Drowsiness
General disorders
Systematic Assessment
EG0006 affected10 at risk
EG00116 affected43 at risk
EG0022 affected11 at risk
EG0032 affected10 at risk
EG00415 affected43 at risk
EG0050 affected2 at risk
Irritability
General disorders
Systematic Assessment
EG0006 affected10 at risk
EG00120 affected43 at risk
EG0024 affected11 at risk
EG0035 affected10 at risk
EG00414 affected43 at risk
EG0050 affected2 at risk
Loss of Appetite
General disorders
Systematic Assessment
EG0006 affected10 at risk
EG00114 affected43 at risk
EG0024 affected11 at risk
EG0033 affected10 at risk
EG0046 affected43 at risk
EG0050 affected2 at risk
Fever
General disorders
Systematic Assessment
For subjects less than 6 years old
EG0005 affected10 at risk
EG00114 affected43 at risk
EG0024 affected11 at risk
EG0033 affected10 at risk
EG00411 affected43 at risk
EG0050 affected2 at risk
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0002 affected10 at risk
EG0019 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0046 affected43 at risk
EG0050 affected24 at risk
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0000 affected10 at risk
EG0014 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0041 affected43 at risk
EG0050 affected24 at risk
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected44 at risk
EG0022 affected23 at risk
EG0030 affected10 at risk
EG0041 affected43 at risk
EG0052 affected24 at risk
Cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected44 at risk
EG0021 affected23 at risk
EG0031 affected10 at risk
EG0042 affected43 at risk
EG0051 affected24 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0031 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Ear infection
Infections and infestations
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Lip haemorrhage
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0031 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Tooth discolouration
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Loss of consciousness
Nervous system disorders
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0031 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected10 at risk
EG0010 affected44 at risk
EG0021 affected23 at risk
EG0031 affected10 at risk
EG0040 affected43 at risk
EG0051 affected24 at risk
Varicella
Infections and infestations
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Pyrexia
General disorders
Non-systematic Assessment
EG0001 affected10 at risk
EG0011 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0042 affected43 at risk
EG0050 affected24 at risk
Erythema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected44 at risk
EG0021 affected23 at risk
EG0030 affected10 at risk
EG0041 affected43 at risk
EG0050 affected24 at risk
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected10 at risk
EG0011 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected10 at risk
EG0010 affected44 at risk
EG0020 affected23 at risk
EG0030 affected10 at risk
EG0040 affected43 at risk
EG0050 affected24 at risk
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.
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
27
BG00511
BG00682
0
OG0040
OG0050
OG00665
0
OG0040
OG0050
OG00665
0
OG0040
OG0050
OG00665
0
OG0040
OG0050
OG00665
10
OG00443
OG00524
OG00665
OG00777
171.4
(118.9 to 247.2)
OG004186.5(148.8 to 233.8)
OG005105.3(75.4 to 147.0)
OG006120.7(100.8 to 144.4)
OG007154.4(129.8 to 183.7)
H1N1 Day 28
Title
Measurements
OG0001810.2(775.2 to 4226.8)
OG0011345.0(1141.9 to 1584.1)
OG002659.7(524.1 to 830.3)
OG003NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG004NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG005NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG0061079.3(915.8 to 1272.0)
OG007NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
Victoria Day 0
Title
Measurements
OG00016.4(3.7 to 71.9)
OG00115.1(10.6 to 21.5)
OG00221.9(14.0 to 34.1)
OG00313.6(7.6 to 24.6)
OG00419.1(14.4 to 25.4)
OG00519.1(12.3 to 29.6)
OG00617.4(13.2 to 22.8)
OG00718.3(14.8 to 22.7)
Victoria Day 28
Title
Measurements
OG000176.8(28.1 to 1111.2)
OG001142.2(93.5 to 216.2)
OG002188.8(103.7 to 343.8)
OG003NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG004NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG005NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG006160.9(115.0 to 225.2)
OG007NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
H3N2 Day 0
Title
Measurements
OG0005.0(5.0 to 5.0)
OG00121.2(13.7 to 32.8)
OG00231.0(19.0 to 50.5)
OG0035.0(5.0 to 5.0)
OG0048.9(6.4 to 12.4)
OG00526.7(16.6 to 42.9)
OG00620.8(15.2 to 28.3)
OG00711.7(8.9 to 15.2)
H3N2 Day 28
Title
Measurements
OG00088.4(35.9 to 217.6)
OG001448.3(265.9 to 755.8)
OG002518.6(304.1 to 884.3)
OG003NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG004NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG005NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
OG006396.3(276.3 to 568.5)
OG007NA(NA to NA)Data not planned to be collected at Day 28, but rather at Month 6.
9
OG00438
OG00523
OG00656
OG00770
172.8
(113.9 to 262.1)
OG004195.6(155.1 to 246.6)
OG005100.3(71.8 to 140.1)
OG006119.7(97.9 to 146.3)
OG007154.6(128.8 to 185.5)
H1N1 Month 6
Title
Measurements
OG0001437.0(595.7 to 3466.6)
OG001565.5(458.1 to 698.2)
OG002335.5(253.1 to 444.7)
OG00393.4(48.6 to 179.5)
OG004172.0(127.9 to 231.4)
OG00574.3(55.4 to 99.6)
OG006509.0(416.9 to 621.5)
OG007120.7(97.2 to 149.8)
Victoria Day 0
Title
Measurements
OG00017.8(2.9 to 110.0)
OG00116.2(10.6 to 24.6)
OG00221.6(13.6 to 34.5)
OG003NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00618.3(13.5 to 24.8)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
Victoria Month 6
Title
Measurements
OG000302.0(115.6 to 788.8)
OG001148.4(97.9 to 225.1)
OG002134.5(82.2 to 220.1)
OG003NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG006154.1(115.3 to 205.9)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2 Day 0
Title
Measurements
OG0005.0(5.0 to 5.0)
OG00120.3(12.4 to 33.0)
OG00229.7(17.9 to 49.2)
OG003NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00620.3(14.5 to 28.2)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2 Month 6
Title
Measurements
OG000127.0(70.1 to 230.0)
OG001160.0(119.1 to 214.8)
OG002252.7(186.3 to 342.8)
OG003NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG006186.8(152.9 to 228.2)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
10
OG00443
OG00524
OG00665
OG00777
10
OG00443
OG00524
OG00665
OG00777
H1N1 Day 28
Title
Measurements
OG0007
OG00135
OG00223
OG003NAData not planned to be collected at Day 28, but rather at Month 6.
OG004NAData not planned to be collected at Day 28, but rather at Month 6.
OG005NAData not planned to be collected at Day 28, but rather at Month 6.
OG00665
OG007NAData not planned to be collected at Day 28, but rather at Month 6.
Victoria Day 0
Title
Measurements
OG0004
OG00125
OG00220
OG0039
OG00439
OG00520
OG00649
OG00768
Victoria Day 28
Title
Measurements
OG0007
OG00135
OG00223
OG003NAData not planned to be collected at Day 28, but rather at Month 6.
OG004NAData not planned to be collected at Day 28, but rather at Month 6.
OG005NAData not planned to be collected at Day 28, but rather at Month 6.
OG00665
OG007NAData not planned to be collected at Day 28, but rather at Month 6.
H3N2 Day 0
Title
Measurements
OG0000
OG00122
OG00219
OG0030
OG00411
OG00519
OG00641
OG00730
H3N2 Day 28
Title
Measurements
OG0007
OG00135
OG00223
OG003NAData not planned to be collected at Day 28, but rather at Month 6.
OG004NAData not planned to be collected at Day 28, but rather at Month 6.
OG005NAData not planned to be collected at Day 28, but rather at Month 6.
OG00665
OG007NAData not planned to be collected at Day 28, but rather at Month 6.
9
OG00438
OG00523
OG00656
OG00770
9
OG00438
OG00523
OG00656
OG00770
H1N1 Month 6
Title
Measurements
OG0006
OG00128
OG00222
OG0039
OG00438
OG00523
OG00656
OG00770
Victoria Day 0
Title
Measurements
OG0003
OG00121
OG00219
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00643
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
Victoria Month 6
Title
Measurements
OG0006
OG00128
OG00222
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00656
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2 Day 0
Title
Measurements
OG0000
OG00117
OG00218
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00635
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2 Month 6
Title
Measurements
OG0006
OG00128
OG00222
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00656
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
0
OG0040
OG0050
OG00665
OG0070
55
Victoria
Title
Measurements
OG0007
OG00130
OG00218
OG00655
H3N2
Title
Measurements
OG0007
OG00135
OG00222
OG00664
9
OG00438
OG00523
OG00656
OG00770
0
OG0041
OG0050
OG00635
OG0071
Victoria
Title
Measurements
OG0005
OG00122
OG00215
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00642
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2
Title
Measurements
OG0006
OG00122
OG00218
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00646
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
10
OG00443
OG00524
OG00665
OG00777
10
OG00443
OG00524
OG00663
OG00777
H1N1 Day 28
Title
Measurements
OG0007
OG00135
OG00223
OG003NAData not planned to be collected at Day 28, but rather at Month 6.
OG004NAData not planned to be collected at Day 28, but rather at Month 6.
OG005NAData not planned to be collected at Day 28, but rather at Month 6.
OG00665
OG007NAData not planned to be collected at Day 28, but rather at Month 6.
Victoria Day 0
Title
Measurements
OG0002
OG0015
OG0027
OG0031
OG0049
OG0057
OG00614
OG00717
Victoria Day 28
Title
Measurements
OG0007
OG00135
OG00221
OG003NAData not planned to be collected at Day 28, but rather at Month 6.
OG004NAData not planned to be collected at Day 28, but rather at Month 6.
OG005NAData not planned to be collected at Day 28, but rather at Month 6.
OG00663
OG007NAData not planned to be collected at Day 28, but rather at Month 6.
H3N2 Day 0
Title
Measurements
OG0000
OG00117
OG00213
OG0030
OG0046
OG00512
OG00630
OG00718
H3N2 Day 28
Title
Measurements
OG0007
OG00135
OG00223
OG003NAData not planned to be collected at Day 28, but rather at Month 6.
OG004NAData not planned to be collected at Day 28, but rather at Month 6.
OG005NAData not planned to be collected at Day 28, but rather at Month 6.
OG00665
OG007NAData not planned to be collected at Day 28, but rather at Month 6.
9
OG00438
OG00523
OG00656
OG00770
9
OG00438
OG00523
OG00654
OG00770
H1N1 Month 6
Title
Measurements
OG0006
OG00128
OG00222
OG0038
OG00436
OG00521
OG00656
OG00765
Victoria Day 0
Title
Measurements
OG0002
OG0015
OG0027
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00614
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
Victoria Month 6
Title
Measurements
OG0006
OG00126
OG00220
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00652
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2 Day 0
Title
Measurements
OG0000
OG00113
OG00212
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00625
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2 Month 6
Title
Measurements
OG0006
OG00128
OG00222
OG003NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00656
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
0
OG0040
OG0050
OG00665
OG0070
8.9
(7.1 to 11.2)
Victoria
Title
Measurements
OG00010.8(5.9 to 19.6)
OG0019.4(6.8 to 12.9)
OG0028.6(5.5 to 13.6)
OG0069.3(7.3 to 11.7)
H3N2
Title
Measurements
OG00017.7(7.2 to 43.5)
OG00121.1(16.3 to 27.4)
OG00216.7(11.4 to 24.6)
OG00619.1(15.6 to 23.4)
9
OG00438
OG00523
OG00656
OG00770
0.5
(0.4 to 0.8)
OG0040.9(0.7 to 1.1)
OG0050.7(0.7 to 0.8)
OG0064.3(3.4 to 5.3)
OG0070.8(0.7 to 0.9)
Victoria
Title
Measurements
OG00017.0(3.1 to 93.9)
OG0019.2(5.9 to 14.2)
OG0026.2(3.8 to 10.2)
OG003NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG0068.4(6.1 to 11.6)
OG007NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
H3N2
Title
Measurements
OG00025.4(14.0 to 46.0)
OG0017.9(5.5 to 11.4)
OG0028.5(5.9 to 12.3)
OG003NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG0069.2(7.2 to 11.8)
OG007NA(NA to NA)Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
0
OG0040
OG0050
OG00665
OG0070
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG000359.1(159.7 to 807.4)
OG001235.4(180.5 to 307.0)
OG002237.6(154.7 to 364.8)
OG006247.3(199.6 to 306.5)
H1N1 Day 28
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG0005706.2(3382.6 to 9626.0)
OG0015860.4(5072.5 to 6770.7)
OG0022052.3(1395.1 to 3019.0)
OG006
Victoria Day 0
ParticipantsOG0007
ParticipantsOG00135
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00665
ParticipantsOG0070
Title
Measurements
OG00020.2(8.3 to 49.2)
OG00119.1(13.9 to 26.2)
OG00225.4(16.6 to 38.9)
OG006
Victoria Day 28
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG00049.3(6.9 to 349.5)
OG00142.3(20.9 to 85.5)
OG00280.8(34.8 to 187.9)
OG006
H3N2 Day 0
ParticipantsOG0007
ParticipantsOG00135
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00665
ParticipantsOG0070
Title
Measurements
OG00030.0(13.5 to 66.9)
OG00184.9(53.7 to 134.5)
OG002139.5(100.8 to 193.0)
OG006
H3N2 Day 28
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG00090.1(50.1 to 162.0)
OG0011011.6(509.5 to 2008.6)
OG0021229.9(586.5 to 2579.3)
OG006
9
OG00438
OG00523
OG00656
OG00770
9
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00655
ParticipantsOG00770
Title
Measurements
OG000419.1(172.0 to 1021.2)
OG001254.8(184.0 to 352.8)
OG002221.2(145.0 to 337.6)
OG003292.0(170.8 to 499.1)
OG004441.3(317.5 to 613.5)
OG005212.8(142.3 to 318.1)
OG006254.2(200.2 to 322.9)
OG007329.3(260.0 to 417.2)
H1N1 Month 6
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0005080.1(2169.7 to 11894.4)
OG0012359.7(1852.0 to 3006.4)
OG002892.2(585.7 to 1359.0)
OG003
Victoria Day 0
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG00021.4(7.2 to 64.0)
OG00120.7(13.9 to 30.7)
OG00226.1(16.8 to 40.6)
OG003
Victoria Month 6
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG000284.5(89.4 to 905.6)
OG001140.0(81.7 to 240.0)
OG002113.1(58.2 to 219.7)
OG003
H3N2 Day 0
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG00034.1(13.6 to 85.3)
OG00178.4(47.0 to 131.1)
OG002136.5(97.4 to 191.3)
OG003
H3N2 Month 6
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG000264.1(136.0 to 512.9)
OG001618.2(435.1 to 878.5)
OG002638.2(381.1 to 1068.8)
OG003
0
OG0040
OG0050
OG00665
OG0070
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG0007
OG00134
OG00223
OG00664
H1N1 Day 28
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG0007
OG00134
OG00223
OG006
Victoria Day 0
ParticipantsOG0007
ParticipantsOG00135
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00665
ParticipantsOG0070
Title
Measurements
OG0001
OG0015
OG0027
OG006
Victoria Day 28
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG0003
OG00115
OG00212
OG006
H3N2 Day 0
ParticipantsOG0007
ParticipantsOG00135
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00665
ParticipantsOG0070
Title
Measurements
OG0004
OG00126
OG00222
OG006
H3N2 Day28
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG0007
OG00134
OG00223
OG006
9
OG00438
OG00523
OG00656
OG00770
9
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00655
ParticipantsOG00770
Title
Measurements
OG0006
OG00127
OG00222
OG0039
OG00438
OG00523
OG00655
OG00770
H1N1 Month 6
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0006
OG00128
OG00222
OG003
Victoria Day 0
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0001
OG0015
OG0027
OG003
Victoria Month 6
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0006
OG00128
OG00218
OG003
H3N2 Day 0
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0004
OG00120
OG00221
OG003
H3N2 Month 6
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0006
OG00128
OG00222
OG003
0
OG0040
OG0050
OG00664
OG0070
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00663
ParticipantsOG0070
Title
Measurements
OG0006
OG00133
OG00217
OG00656
Victoria
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG0003
OG00111
OG00211
OG006
H3N2
ParticipantsOG0007
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00664
ParticipantsOG0070
Title
Measurements
OG0004
OG00132
OG00216
OG006
9
OG00438
OG00523
OG00656
OG00770
9
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00655
ParticipantsOG00770
Title
Measurements
OG0005
OG00122
OG00210
OG0030
OG0042
OG0050
OG00637
OG0072
Victoria
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0006
OG00123
OG00213
OG003
H3N2
ParticipantsOG0006
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG0039
ParticipantsOG00438
ParticipantsOG00523
ParticipantsOG00656
ParticipantsOG00770
Title
Measurements
OG0005
OG00121
OG00213
OG003
10
OG00443
OG00524
5
OG00419
OG00514
Grade 3 Pain
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0050
Any Redness
Title
Measurements
OG0007
OG00133
OG00219
OG0032
OG00415
OG0059
Grade 3 Redness
Title
Measurements
OG0002
OG0018
OG0026
OG0030
OG0040
OG0050
Any Swelling
Title
Measurements
OG0005
OG00123
OG00211
OG0031
OG00410
OG0055
Grade 3 Swelling
Title
Measurements
OG0001
OG0013
OG0022
OG0030
OG0040
OG0050
5
OG00419
OG00514
5
ParticipantsOG00419
ParticipantsOG00514
Title
Measurements
OG0001.0(1.0 to 2.0)
OG0012.0(1.0 to 5.0)
OG0022.0(1.0 to 5.0)
OG0031.0(1.0 to 5.0)
OG0041.0(1.0 to 7.0)
OG0052.0(1.0 to 4.0)
Redness [Dose 1]
ParticipantsOG0006
ParticipantsOG00130
ParticipantsOG00216
ParticipantsOG0032
ParticipantsOG00415
ParticipantsOG0059
Title
Measurements
OG0004.0(1.0 to 6.0)
OG0013.0(1.0 to 7.0)
OG0023.0(1.0 to 6.0)
OG003
Swelling [Dose 1]
ParticipantsOG0005
ParticipantsOG00118
ParticipantsOG0029
ParticipantsOG0031
ParticipantsOG00410
ParticipantsOG0055
Title
Measurements
OG0002.0(1.0 to 5.0)
OG0013.0(1.0 to 6.0)
OG0022.0(1.0 to 6.0)
OG003
Pain [Dose 2]
ParticipantsOG0002
ParticipantsOG00121
ParticipantsOG00214
ParticipantsOG0035
ParticipantsOG00419
ParticipantsOG00514
Title
Measurements
OG0001.5(1.0 to 2.0)
OG0011.0(1.0 to 3.0)
OG0022.0(1.0 to 3.0)
OG003
Redness [Dose 2]
ParticipantsOG0004
ParticipantsOG00123
ParticipantsOG00213
ParticipantsOG0035
ParticipantsOG00419
ParticipantsOG00514
Title
Measurements
OG0003.0(3.0 to 7.0)
OG0013.0(1.0 to 6.0)
OG0022.0(1.0 to 5.0)
OG003
Swelling [Dose 2]
ParticipantsOG0002
ParticipantsOG00116
ParticipantsOG0028
ParticipantsOG0035
ParticipantsOG00419
ParticipantsOG00514
Title
Measurements
OG0003.0(2.0 to 4.0)
OG0012.0(1.0 to 6.0)
OG0022.0(1.0 to 4.0)
OG003
10
OG00443
OG0052
2
OG0047
OG0050
Grade 3 Diarrhoea
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Related Diarrhoea
Title
Measurements
OG0005
OG0013
OG0021
OG0032
OG0043
OG0050
Any Drowsiness
Title
Measurements
OG0006
OG00116
OG0022
OG0032
OG00415
OG0050
Grade 3 Drowsiness
Title
Measurements
OG0000
OG0013
OG0021
OG0030
OG0042
OG0050
Related Drowsiness
Title
Measurements
OG0005
OG00110
OG0022
OG0032
OG0049
OG0050
Any Irritability
Title
Measurements
OG0006
OG00120
OG0024
OG0035
OG00414
OG0050
Grade 3 Irritability
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0042
OG0050
Related Irritability
Title
Measurements
OG0005
OG00114
OG0023
OG0034
OG00410
OG0050
Any Loss of Appetite
Title
Measurements
OG0006
OG00114
OG0024
OG0033
OG0046
OG0050
Grade 3 Loss of Appetite
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Related Loss of Appetite
Title
Measurements
OG0004
OG0018
OG0024
OG0032
OG0043
OG0050
Any Fever
Title
Measurements
OG0005
OG00114
OG0024
OG0033
OG00411
OG0050
Grade 3 Fever
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0040
OG0050
Related Fever
Title
Measurements
OG0004
OG00111
OG0023
OG0030
OG0044
OG0050
5
OG00415
OG0050
2
ParticipantsOG0047
ParticipantsOG0050
Title
Measurements
OG0002.0(2.0 to 3.0)
OG0012.0(1.0 to 4.0)
OG0021.0(1.0 to 1.0)
OG0033.5(1.0 to 6.0)
OG0041.0(1.0 to 3.0)
Drowsiness [Dose 1]
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG00415
ParticipantsOG0050
Title
Measurements
OG0001.5(1.0 to 6.0)
OG0011.0(1.0 to 4.0)
OG0023.0(3.0 to 3.0)
OG003
Irritability [Dose 1]
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00414
ParticipantsOG0050
Title
Measurements
OG0002.5(1.0 to 4.0)
OG0012.0(1.0 to 5.0)
OG0021.0(1.0 to 2.0)
OG003
Loss of Appetite [Dose 1]
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0046
ParticipantsOG0050
Title
Measurements
OG0002.0(1.0 to 6.0)
OG0013.0(1.0 to 5.0)
OG0021.0(1.0 to 3.0)
OG003
Fever [Dose 1]
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG00411
ParticipantsOG0050
Title
Measurements
OG0004.0(1.0 to 6.0)
OG0011.5(1.0 to 3.0)
OG0021.5(1.0 to 2.0)
OG003
Diarrhoea [Dose 2]
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0035
ParticipantsOG00415
ParticipantsOG0050
Title
Measurements
OG0001.0(1.0 to 3.0)
OG0011.0(1.0 to 4.0)
OG0021.0(1.0 to 1.0)
OG003
Drowsiness [Dose 2]
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0022
ParticipantsOG0035
ParticipantsOG00415
ParticipantsOG0050
Title
Measurements
OG0001.5(1.0 to 3.0)
OG0011.0(1.0 to 2.0)
OG0021.0(1.0 to 1.0)
OG003
Irritability [Dose 2]
ParticipantsOG0005
ParticipantsOG00112
ParticipantsOG0022
ParticipantsOG0035
ParticipantsOG00415
ParticipantsOG0050
Title
Measurements
OG0002.0(2.0 to 7.0)
OG0012.0(1.0 to 4.0)
OG0022.0(1.0 to 3.0)
OG003
Loss of Appetite [Dose 2]
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0022
ParticipantsOG0035
ParticipantsOG00415
ParticipantsOG0050
Title
Measurements
OG0002.0(1.0 to 5.0)
OG0012.0(1.0 to 4.0)
OG0021.0(1.0 to 1.0)
OG003
Fever [Dose 2]
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG0022
ParticipantsOG0035
ParticipantsOG00415
ParticipantsOG0050
Title
Measurements
OG0002.0(1.0 to 2.0)
OG0011.0(1.0 to 7.0)
OG0021.0(1.0 to 1.0)
OG003
0
OG0040
OG00522
0
OG0050
Related Arthralgia
Title
Measurements
OG0020
OG0050
Any Fatigue
Title
Measurements
OG0025
OG0058
Grade 3 Fatigue
Title
Measurements
OG0020
OG0050
Related Fatigue
Title
Measurements
OG0024
OG0056
Any Gatrointestinal Symptoms
Title
Measurements
OG0021
OG0051
Grade 3 Gatrointestinal Symptoms
Title
Measurements
OG0020
OG0050
Related Gatrointestinal Symptoms
Title
Measurements
OG0021
OG0051
Any Headache
Title
Measurements
OG0024
OG0054
Grade 3 Headache
Title
Measurements
OG0020
OG0050
Related Headache
Title
Measurements
OG0023
OG0053
Any Myalgia
Title
Measurements
OG0021
OG0052
Grade 3 Myalgia
Title
Measurements
OG0020
OG0050
Related Myalgia
Title
Measurements
OG0021
OG0052
Any Shivering
Title
Measurements
OG0022
OG0050
Grade 3 Shivering
Title
Measurements
OG0020
OG0050
Related Shivering
Title
Measurements
OG0022
OG0050
Any Sweating
Title
Measurements
OG0020
OG0050
Grade 3 Sweating
Title
Measurements
OG0020
OG0050
Related Sweating
Title
Measurements
OG0020
OG0050
Any Fever
Title
Measurements
OG0023
OG0050
Grade 3 Fever
Title
Measurements
OG0020
OG0050
Related Fever
Title
Measurements
OG0022
OG0050
0
OG0040
OG0058
0
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG0021.5(1.0 to 5.0)
OG0051.0(1.0 to 2.0)
Fatigue [Dose 2]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG0024.0(1.0 to 7.0)
OG005NA(NA to NA)Dose 2 involved subjects in Group receiving Fluarix vaccine.
Gastrointestinal Symptoms [Dose 1]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0051
Title
Measurements
OG0022.0(2.0 to 2.0)
OG0051.0(1.0 to 1.0)
Gastrointestinal symptoms [Dose 2]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG002NA(NA to NA)None of the subjects aged above 6 years in this group experienced this symptom
OG005NA(NA to NA)Dose 2 involved subjects in Group receiving Fluarix vaccine.
Headache [Dose 1]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0054
Title
Measurements
OG0023.0(2.0 to 4.0)
OG0053.0(1.0 to 7.0)
Headache [Dose 2]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG0023.5(3.0 to 4.0)
OG005NA(NA to NA)Dose 2 involved subjects in Group receiving Fluarix vaccine.
Myalgia [Dose 1]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0052
Title
Measurements
OG002NA(NA to NA)None of the subjects aged above 6 years in this group experienced this symptom.
OG0051.0(1.0 to 1.0)
Myalgia [Dose 2]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG0021.0(1.0 to 1.0)
OG005NA(NA to NA)Dose 2 involved subjects in Group receiving Fluarix vaccine.
Shivering [Dose 1]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG0021.0(1.0 to 1.0)
OG005NA(NA to NA)None of the subjects aged above 6 years in this group experienced this symptom.
Shivering [Dose 2]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG002NA(NA to NA)None of the subjects aged above 6 years in this group experienced this symptom
OG005NA(NA to NA)Dose 2 involved subjects in Group receiving Fluarix vaccine.
Fever [Dose 1]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG0021.0(1.0 to 1.0)
OG005NA(NA to NA)None of the subjects aged above 6 years in this group experienced this symptom.
Fever [Dose2]
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0058
Title
Measurements
OG0021.0(1.0 to 1.0)
OG005NA(NA to NA)Dose 2 involved subjects in Group receiving Fluarix vaccine.
10
OG00443
OG00524
3
OG00415
OG0057
Grade 3 AEs
Title
Measurements
OG0003
OG0014
OG0021
OG0030
OG0041
OG0051
Related AEs
Title
Measurements
OG0002
OG0011
OG0022
OG0030
OG0041
OG0050
10
OG00443
OG00524
3
OG0047
OG0051
AESIs / pIMDs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
AEs of special interest
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
10
OG00443
OG00524
0
OG0040
OG0050
10
OG00443
OG00524
0
OG0040
OG0050
4007.7
(3274.8 to 4904.6)
21.3
(16.8 to 26.9)
54.3
(33.0 to 89.3)
90.5
(67.4 to 121.6)
832.9
(514.7 to 1347.8)
292.6
(173.6 to 493.0)
OG004528.9(377.5 to 741.0)
OG005221.6(155.0 to 316.8)
OG0061748.2(1347.3 to 2268.4)
OG007368.3(290.1 to 467.5)
NA
(NA to NA)
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00622.7(17.4 to 29.7)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
NA
(NA to NA)
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG006138.9(95.2 to 202.6)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
NA
(NA to NA)
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00689.2(65.5 to 121.5)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
NA
(NA to NA)
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG006571.5(435.5 to 749.8)
OG007NA(NA to NA)Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
64
13
30
52
64
9
OG00438
OG00523
OG00656
OG00770
NA
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00613
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
NA
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00652
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
NA
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00645
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
NA
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00656
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
25
52
NA
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00642
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
NA
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG004NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG005NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
OG00639
OG007NAResults were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
1.5
(1.0 to 2.0)
OG0043.0(1.0 to 7.0)
OG0052.0(1.0 to 5.0)
1.0
(1.0 to 1.0)
OG0042.0(1.0 to 7.0)
OG0052.0(1.0 to 3.0)
NA
(NA to NA)
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
OG004NA(NA to NA)None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
OG005NA(NA to NA)None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
NA
(NA to NA)
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
OG004NA(NA to NA)None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
OG005NA(NA to NA)None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
NA
(NA to NA)
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
OG004NA(NA to NA)None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
OG005NA(NA to NA)None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
2.0
(2.0 to 2.0)
OG0042.0(1.0 to 6.0)
2.0
(1.0 to 6.0)
OG0041.0(1.0 to 5.0)
2.0
(1.0 to 7.0)
OG0041.5(1.0 to 3.0)
2.0
(2.0 to 2.0)
OG0042.0(1.0 to 6.0)
NA
(NA to NA)
None of the subjects in any of the Havrix Groups received a second vaccine dose.
OG004NA(NA to NA)None of the subjects in any of the Havrix Groups received a second vaccine dose.
NA
(NA to NA)
None of the subjects in any of the Havrix Groups received a second vaccine dose.
OG004NA(NA to NA)None of the subjects in any of the Havrix Groups received a second vaccine dose.
NA
(NA to NA)
None of the subjects in any of the Havrix Groups received a second vaccine dose.
OG004NA(NA to NA)None of the subjects in any of the Havrix Groups received a second vaccine dose.
NA
(NA to NA)
None of the subjects in any of the Havrix Groups received a second vaccine dose.
OG004NA(NA to NA)None of the subjects in any of the Havrix Groups received a second vaccine dose.
NA
(NA to NA)
None of the subjects in any of the Havrix Groups received a second vaccine dose.
OG004NA(NA to NA)None of the subjects in any of the Havrix Groups received a second vaccine dose.