Influenza
Conditions
Keywords
Influenza, H1N1, Fluarix, Pandemrix
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.
Interventions
BIOLOGICALFluarix™
One or two intramuscular injections
BIOLOGICALHavrix™ Junior
Two intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
Yes
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. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 0 and 28 | Antibody titers were expressed as Geometric mean titers (GMTs). |
| Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 0-28 | Seropositivity was defined as antibody titers greater than or equal to 1:10. |
| Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 0-28 | 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. |
| Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 28 | 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. |
| Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Month 6 | 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. |
| Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only) | 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. |
| Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Day 0 and Month 6 | 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. |
| Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Day 28 | 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. |
| Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Month 6 | 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. |
| Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only) | Antibody titers were expressed as Geometric Mean Titers (GMTs). |
| Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Day 0 and Month 6 | 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. |
| Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only) | Seropositivity was defined as antibody titers greater than or equal to 1:28. |
| Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Day 0 and Month 6 | 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. |
| Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | Day 28 | Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response. |
| HI Antibody Titers Against All Fluarix Vaccine Strains | Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only) | 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. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 7 days (Day 0 - 6) after vaccination | 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. |
| Duration of Any Solicited Local Symptom | During the 7 days (Days 0 - 6) after vaccination | Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling. |
| Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 7 days (Days 0-6) after vaccination | 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. |
| Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | During a 7-day follow-up period (Day 0-6) after vaccination | Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. |
| Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | During a 7-day follow-up period (Day 0-6) after vaccination | 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. |
| Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | During a 7-day follow-up period (Day 0-6) after vaccination | Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During a 28 day follow-up period (Day 0-27) after vaccination | 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. |
| 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 | During the entire study period (up to Month 6) | 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. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Up to Day 28 | 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. |
| Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Month 6 | 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. |
| HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Day 0 and Month 6 | 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. |
| Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only) | 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. |
| Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Day 0 and Month 6 | 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. |
| Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Day 28 | 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. |
Countries
Netherlands, Sweden
Participant flow
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fluarix 6-11 Months Group Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. | 10 |
| Fluarix 12-35 Months Group Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. | 44 |
| Fluarix 3-9 Years Group Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. | 23 |
| Havrix Junior 6-11 Months Group Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. | 10 |
| 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. | 43 |
| Havrix Junior 3-9 Years Group Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. | 24 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Fluarix 6-11 Months Group | Fluarix 12-35 Months Group | Fluarix 3-9 Years Group | Havrix Junior 6-11 Months Group | Havrix Junior 12-35 Months Group | Havrix Junior 3-9 Years Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 1.0 Years STANDARD_DEVIATION 0 | 2.3 Years STANDARD_DEVIATION 0.52 | 6.4 Years STANDARD_DEVIATION 1.99 | 1.0 Years STANDARD_DEVIATION 0 | 2.4 Years STANDARD_DEVIATION 0.58 | 7.5 Years STANDARD_DEVIATION 1.53 | 3.58 Years STANDARD_DEVIATION 2.54 |
| Sex: Female, Male Female | 5 Participants | 21 Participants | 13 Participants | 4 Participants | 16 Participants | 13 Participants | 72 Participants |
| Sex: Female, Male Male | 5 Participants | 23 Participants | 10 Participants | 6 Participants | 27 Participants | 11 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 10 | 41 / 44 | 23 / 23 | 9 / 10 | 34 / 43 | 20 / 24 |
| serious Total, serious adverse events | 1 / 10 | 1 / 44 | 0 / 23 | 0 / 10 | 0 / 43 | 0 / 24 |
Outcome results
Primary
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Antibody titers were expressed as Geometric mean titers (GMTs).
Time frame: Day 0 and 28
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix All Ages Group | Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 0 | 120.7 titer |
| Fluarix All Ages Group | Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 28 | 1079.3 titer |
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluarix All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine | 8.9 ratio |
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | 55 Participants |
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.
Time frame: Day 0-28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 0 | 65 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 28 | 65 Participants |
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.
Time frame: Day 0-28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 0 | 63 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine | Day 28 | 65 Participants |
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.
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fatigue [Dose 1] | 1.5 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fatigue [Dose 2] | 4.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Gastrointestinal Symptoms [Dose 1] | 2.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Gastrointestinal symptoms [Dose 2] | NA days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Headache [Dose 1] | 3.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Headache [Dose 2] | 3.5 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Myalgia [Dose 1] | NA days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Myalgia [Dose 2] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Shivering [Dose 1] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Shivering [Dose 2] | NA days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fever [Dose 1] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fever [Dose2] | 1.0 days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fever [Dose 1] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fatigue [Dose 1] | 1.0 days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Myalgia [Dose 1] | 1.0 days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fatigue [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Shivering [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Gastrointestinal Symptoms [Dose 1] | 1.0 days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Headache [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Myalgia [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Gastrointestinal symptoms [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Fever [Dose2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Headache [Dose 1] | 3.0 days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old | Shivering [Dose 1] | NA days |
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.
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 1] | 1.5 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 2] | 1.5 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 2] | 2.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 1] | 2.5 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 2] | 2.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 1] | 2.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 1] | 2.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 2] | 2.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 1] | 4.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 2] | 1.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 1] | 2.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 1] | 2.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 1] | 3.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 2] | 2.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 2] | 1.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 2] | 1.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 1] | 1.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 1] | 1.5 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 2] | 2.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 2] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 1] | 3.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 1] | 1.5 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 2] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 1] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 1] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 2] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 2] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 2] | 2.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 1] | 1.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 2] | 1.0 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 2] | NA days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 1] | 3.5 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 1] | 2.0 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 1] | 2.0 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 1] | 2.0 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 1] | 2.0 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 2] | NA days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 2] | NA days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 2] | NA days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 2] | NA days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 2] | NA days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 2] | NA days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 1] | 2.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 1] | 1.5 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Loss of Appetite [Dose 2] | NA days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 1] | 1.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Drowsiness [Dose 1] | 2.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Diarrhoea [Dose 1] | 1.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Fever [Dose 2] | NA days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old | Irritability [Dose 2] | NA days |
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.
Time frame: During the 7 days (Days 0 - 6) after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 1] | 1.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 1] | 4.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 1] | 2.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 2] | 1.5 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 2] | 3.0 days |
| Fluarix 6-11 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 2] | 3.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 2] | 1.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 1] | 3.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 2] | 2.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 1] | 3.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 1] | 2.0 days |
| Fluarix 12-35 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 2] | 3.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited Local Symptom | Swelling [Dose 2] | 2.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited Local Symptom | Pain [Dose 2] | 2.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited Local Symptom | Redness [Dose 1] | 3.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited Local Symptom | Swelling [Dose 1] | 2.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited Local Symptom | Pain [Dose 1] | 2.0 days |
| Fluarix 3-9 Years Group | Duration of Any Solicited Local Symptom | Redness [Dose 2] | 2.0 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 2] | NA days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 1] | 1.5 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 1] | 1.0 days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 2] | NA days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 2] | NA days |
| Havrix Junior 6-11 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 1] | 1.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 1] | 1.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 1] | 3.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited Local Symptom | Redness [Dose 2] | NA days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 1] | 2.0 days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited Local Symptom | Pain [Dose 2] | NA days |
| Havrix Junior 12-35 Months Group | Duration of Any Solicited Local Symptom | Swelling [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited Local Symptom | Pain [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited Local Symptom | Swelling [Dose 1] | 2.0 days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited Local Symptom | Redness [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited Local Symptom | Swelling [Dose 2] | NA days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited Local Symptom | Redness [Dose 1] | 2.0 days |
| Havrix Junior 3-9 Years Group | Duration of Any Solicited Local Symptom | Pain [Dose 1] | 2.0 days |
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.
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 176.6 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 5.0 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 1810.2 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 16.4 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 88.4 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 176.8 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 142.2 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 15.1 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 448.3 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 21.2 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 1345.0 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 124.9 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 518.6 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 102.0 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 659.7 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 21.9 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 188.8 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 31.0 titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 5.0 titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 13.6 titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | NA titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 171.4 titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 8.9 titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | NA titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 19.1 titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 186.5 titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 26.7 titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 19.1 titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 105.3 titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | NA titer |
| Fluarix All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 120.7 titer |
| Fluarix All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 17.4 titer |
| Fluarix All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 160.9 titer |
| Fluarix All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 396.3 titer |
| Fluarix All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 20.8 titer |
| Fluarix All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 1079.3 titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 154.4 titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | NA titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 18.3 titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 11.7 titer |
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.
Time frame: Day 0 and Month 6
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 127.0 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 201.6 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 1437.0 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 17.8 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 5.0 titer |
| Fluarix 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 302.0 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 16.2 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 126.4 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 148.4 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 160.0 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 565.5 titer |
| Fluarix 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 20.3 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 29.7 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 21.6 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 335.5 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 134.5 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 252.7 titer |
| Fluarix 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 96.9 titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 172.8 titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 93.4 titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior 6-11 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 172.0 titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 195.6 titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior 12-35 Months Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 74.3 titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 100.3 titer |
| Havrix Junior 3-9 Years Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Fluarix All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 154.1 titer |
| Fluarix All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 20.3 titer |
| Fluarix All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 119.7 titer |
| Fluarix All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 18.3 titer |
| Fluarix All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 186.8 titer |
| Fluarix All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 509.0 titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 154.6 titer |
| Havrix Junior All Ages Group | HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 120.7 titer |
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 10.2 ratio |
| Fluarix 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 17.7 ratio |
| Fluarix 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 10.8 ratio |
| Fluarix 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 10.8 ratio |
| Fluarix 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 21.1 ratio |
| Fluarix 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 9.4 ratio |
| Fluarix 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 6.5 ratio |
| Fluarix 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 8.6 ratio |
| Fluarix 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 16.7 ratio |
| Fluarix All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 8.9 ratio |
| Fluarix All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 19.1 ratio |
| Fluarix All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 9.3 ratio |
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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 7.1 ratio |
| Fluarix 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 25.4 ratio |
| Fluarix 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 17.0 ratio |
| Fluarix 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 7.9 ratio |
| Fluarix 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 9.2 ratio |
| Fluarix 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 4.5 ratio |
| Fluarix 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 8.5 ratio |
| Fluarix 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 3.5 ratio |
| Fluarix 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 6.2 ratio |
| Havrix Junior 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0.5 ratio |
| Havrix Junior 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA ratio |
| Havrix Junior 6-11 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA ratio |
| Havrix Junior 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA ratio |
| Havrix Junior 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0.9 ratio |
| Havrix Junior 12-35 Months Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA ratio |
| Havrix Junior 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA ratio |
| Havrix Junior 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0.7 ratio |
| Havrix Junior 3-9 Years Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA ratio |
| Fluarix All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 8.4 ratio |
| Fluarix All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 4.3 ratio |
| Fluarix All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 9.2 ratio |
| Havrix Junior All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0.8 ratio |
| Havrix Junior All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA ratio |
| Havrix Junior All Ages Group | Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA ratio |
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.
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 3 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 2 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 2 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 4 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 2 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 5 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 3 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 4 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Gatrointestinal Symptoms | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gatrointestinal Symptoms | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Gatrointestinal Symptoms | 1 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 4 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 3 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 2 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 2 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Sweating | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Sweating | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Gatrointestinal Symptoms | 1 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 8 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 6 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Any Gatrointestinal Symptoms | 1 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gatrointestinal Symptoms | 0 Participants |
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.
Time frame: During the 7 days (Days 0-6) after vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of Appetite | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of Appetite | 4 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of Appetite | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 4 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 5 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of Appetite | 8 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 14 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of Appetite | 14 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea | 3 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea | 8 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 16 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 14 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 3 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 11 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 10 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 20 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea | 0 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of Appetite | 1 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of Appetite | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 2 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea | 2 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 3 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 4 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 3 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 4 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of Appetite | 4 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 2 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of Appetite | 4 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea | 2 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea | 2 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 2 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 2 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 5 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 4 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of Appetite | 3 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of Appetite | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of Appetite | 2 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 3 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 14 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 11 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea | 7 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of Appetite | 3 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea | 3 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of Appetite | 0 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 4 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 2 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 9 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 10 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 15 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea | 1 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of Appetite | 6 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 2 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of Appetite | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of Appetite | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of Appetite | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
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.
Time frame: During the 7 days (Day 0 - 6) after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 3 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 2 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 1 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 8 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 33 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 2 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 11 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 6 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 19 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 21 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 2 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 1 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 5 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 19 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 10 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 15 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness | 9 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling | 5 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain | 14 Participants |
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.
Time frame: During a 28 day follow-up period (Day 0-27) after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 3 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 2 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 4 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 20 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 7 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 2 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 3 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 0 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 15 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 7 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
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.
Time frame: During the entire study period (up to Month 6)
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | 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 | AESIs / pIMDs | 0 Participants |
| Fluarix 6-11 Months Group | 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 | 4 Participants |
| Fluarix 6-11 Months Group | 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 | AEs of special interest | 0 Participants |
| Fluarix 12-35 Months Group | 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 | AESIs / pIMDs | 0 Participants |
| Fluarix 12-35 Months Group | 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 | 11 Participants |
| Fluarix 12-35 Months Group | 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 | AEs of special interest | 0 Participants |
| Fluarix 3-9 Years Group | 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 | AESIs / pIMDs | 0 Participants |
| Fluarix 3-9 Years Group | 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 | 2 Participants |
| Fluarix 3-9 Years Group | 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 | AEs of special interest | 0 Participants |
| Havrix Junior 6-11 Months Group | 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 | AESIs / pIMDs | 0 Participants |
| Havrix Junior 6-11 Months Group | 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 | 3 Participants |
| Havrix Junior 6-11 Months Group | 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 | AEs of special interest | 0 Participants |
| Havrix Junior 12-35 Months Group | 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 | AESIs / pIMDs | 0 Participants |
| Havrix Junior 12-35 Months Group | 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 | 7 Participants |
| Havrix Junior 12-35 Months Group | 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 | AEs of special interest | 0 Participants |
| Havrix Junior 3-9 Years Group | 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 | 1 Participants |
| Havrix Junior 3-9 Years Group | 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 | AEs of special interest | 0 Participants |
| Havrix Junior 3-9 Years Group | 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 | AESIs / pIMDs | 0 Participants |
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.
Time frame: Up to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: Up to Day 28
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 7 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 31 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 30 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 18 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 19 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 22 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H1N1 | 55 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | H3N2 | 64 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine | Victoria | 55 Participants |
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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 6 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 22 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 22 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 18 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 12 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 15 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 18 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 1 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 42 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 35 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 46 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 1 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H1N1 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H3N2 | 4 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | Victoria | 3 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H1N1 | 33 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H3N2 | 32 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | Victoria | 11 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | Victoria | 11 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H1N1 | 17 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H3N2 | 16 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H1N1 | 56 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | H3N2 | 52 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix | Victoria | 25 Participants |
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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 5 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 6 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 21 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 23 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 13 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 10 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 13 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 2 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 0 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | 42 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 37 Participants |
| Fluarix All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | 39 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 | 2 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 | NA Participants |
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.
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 4 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 7 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 25 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 19 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 20 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 23 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 10 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 9 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 11 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 43 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 39 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 20 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 19 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 24 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 65 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 41 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 65 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 49 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 65 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 65 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 68 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 30 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 77 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
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.
Time frame: Day 0 and Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 3 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 17 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 21 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 18 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 19 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 22 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 9 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 9 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 38 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 38 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 23 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 23 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 56 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 43 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 35 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 56 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 56 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 56 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 70 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 70 Participants |
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.
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 1 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 3 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 4 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day28 | 7 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day28 | 34 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 15 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 34 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 5 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 34 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 26 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 7 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 12 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day28 | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 23 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 52 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H3N2 Day28 | 64 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 64 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 30 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 64 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 13 Participants |
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.
Time frame: Day 0 and Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 1 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 4 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 6 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 5 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 27 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 20 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 21 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 7 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 18 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 22 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 9 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 9 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 38 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 38 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 23 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 23 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 52 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 45 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 55 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 13 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 56 Participants |
| Fluarix All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 56 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 70 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 70 Participants |
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.
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 7 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 2 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 7 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 5 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 33 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 35 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 17 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 13 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 7 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 21 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 23 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 23 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 0 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 10 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 1 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 6 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 43 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 9 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 7 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 12 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 24 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 30 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | 65 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | 65 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 63 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 14 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | 63 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 0 | 77 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 0 | 17 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 0 | 18 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H3N2 Day 28 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | H1N1 Day 28 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains | Victoria Day 28 | NA Participants |
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.
Time frame: Day 0 and Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 2 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 0 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 6 Participants |
| Fluarix 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 6 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 26 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 5 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 28 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 26 Participants |
| Fluarix 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 13 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 20 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 22 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 12 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 7 Participants |
| Fluarix 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 22 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 9 Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 6-11 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 8 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 36 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 38 Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 12-35 Months Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 21 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 23 Participants |
| Havrix Junior 3-9 Years Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 56 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 56 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 25 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 54 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 52 Participants |
| Fluarix All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 14 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 65 Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA Participants |
| Havrix Junior All Ages Group | Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 70 Participants |
Secondary
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 49.3 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 359.1 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 20.2 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 5706.2 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 30.0 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 90.1 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 84.9 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 1011.6 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 5860.4 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 19.1 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 235.4 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 42.3 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 2052.3 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 139.5 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 80.8 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 237.6 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 25.4 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 1229.9 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 28 | 832.9 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 28 | 4007.7 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 0 | 21.3 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | Victoria Day 28 | 54.3 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H3N2 Day 0 | 90.5 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains | H1N1 Day 0 | 247.3 titer |
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.
Time frame: Day 0 and Month 6
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 264.1 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 419.1 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 5080.1 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 21.4 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 34.1 titer |
| Fluarix 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 284.5 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 20.7 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 254.8 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 140.0 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 618.2 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 2359.7 titer |
| Fluarix 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 78.4 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 136.5 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 26.1 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 892.2 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 113.1 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 638.2 titer |
| Fluarix 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 221.2 titer |
| Havrix Junior 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 292.0 titer |
| Havrix Junior 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 292.6 titer |
| Havrix Junior 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior 6-11 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Havrix Junior 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 528.9 titer |
| Havrix Junior 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Havrix Junior 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 441.3 titer |
| Havrix Junior 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior 12-35 Months Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 221.6 titer |
| Havrix Junior 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 212.8 titer |
| Havrix Junior 3-9 Years Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | 138.9 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | 89.2 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 254.2 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | 22.7 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | 571.5 titer |
| Fluarix All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 1748.2 titer |
| Havrix Junior All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Month 6 | NA titer |
| Havrix Junior All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | Victoria Day 0 | NA titer |
| Havrix Junior All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Month 6 | NA titer |
| Havrix Junior All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H3N2 Day 0 | NA titer |
| Havrix Junior All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Day 0 | 329.3 titer |
| Havrix Junior All Ages Group | Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine | H1N1 Month 6 | 368.3 titer |