Influenza
Conditions
Keywords
influenza infection, GSK Bio's influenza vaccine GSK2340272A
Brief summary
The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
Interventions
BIOLOGICALPandemrix (GSK investigational influenza GSK2340272A vaccine)
2 doses intramuscular injections
BIOLOGICALFluarix™
1 dose intramuscular injection
BIOLOGICALPlacebo
1 dose intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
61 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects 61 years of age or older at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical or psychiatric conditions). Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
Exclusion criteria
* Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere influenza vaccine. * Previous administration of a pandemic influenza vaccine. * Administration of any vaccine within 30 days before first vaccination. * Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with the GSK2340272A candidate vaccine. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial. * Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Presence of an axillary temperature \>= 37.5°C, or acute symptoms greater than mild severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are eligible and may be enrolled within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above. * Women who are disease free for 3 years or more after the treatment of breast cancer and receiving long-term prophylactic tamoxifen are eligible and may be enrolled. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination and during the entire study period. * Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. * An acute evolving neurological disorder or history of Guillain-Barré syndrome. * Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included, as well as subjects with well controlled underlying diseases). * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests. * 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 chronic alcohol consumption and/or drug abuse. * Clinically or virologically confirmed influenza infection within 6 months preceding the study start. * Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain | At Day 42 | Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09. |
| Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain | At Day 42 | The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity. |
| Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain | At Day 42 | The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. |
| Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain | At Day 42 | Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09. |
| Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain | At Day 42 | The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix | Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). |
| Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix | Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius) |
| Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 | Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (Day 0-364) | SAEs assessed include 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 With AEs of Specific Interest | During the entire study period (Day 0-364) | Adverse events of specific interest included auto-immune diseases and other immune mediated disorders. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During 21 days (Day 0-20) after each 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: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination |
| Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 | The cut-off was a titer of 1:10 and this titer was considered as seropositivity. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. |
| Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. | A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63). |
| Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. | For the definition of seroconversion factor, please refer to the primary outcome measure. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63). |
| Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 | A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo-Pandemrix-Fluarix Group Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. | 72 |
| Fluarix-Pandemrix-Placebo Group Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. | 73 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo-Pandemrix-Fluarix Group | Fluarix-Pandemrix-Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 69.1 Years STANDARD_DEVIATION 5.16 | 69.7 Years STANDARD_DEVIATION 5.59 | 69.4 Years STANDARD_DEVIATION 5.37 |
| Sex: Female, Male Female | 39 Participants | 34 Participants | 73 Participants |
| Sex: Female, Male Male | 33 Participants | 39 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 59 / 72 | 57 / 73 |
| serious Total, serious adverse events | 11 / 72 | 14 / 73 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain
Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.
Time frame: At Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain | 309.8 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain | 227.5 titer |
Primary
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: At Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain | 61 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain | 59 subjects |
Primary
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain
The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.
Time frame: At Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain | 64 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain | 67 subjects |
Primary
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain
The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity.
Time frame: At Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain | 64 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain | 67 subjects |
Primary
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09.
Time frame: At Day 42
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain | 33.6 fold increase |
| Fluarix-Pandemrix-Placebo Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain | 16.5 fold increase |
Secondary
Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Time frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Bri/59/07 (N=63;66) | 55.7 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Cal/7/09 (N=64;67) | 9.2 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 B/Bri/60/08 (N=64;67) | 120.7 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 35.6 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 B/Bri/60/08 (N=64;67) | 118.8 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Cal/7/09 (N=64;67) | 8.7 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 B/Bri/60/08 (N=64;67) | 182.2 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Bri/59/07 (N=64;67) | 23.1 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 B/Bri/60/08 (N=63;66) | 291.3 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 147.5 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Uru/716/07 (N=64;67) | 26.2 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Bri/59/07 (N=64;67) | 22.4 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Uru/716/07 (N=64;67) | 25.5 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 102.0 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Uru/716/07 (N=64;67) | 27.1 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Bri/59/07 (N=64;67) | 32.3 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Uru/716/07 (N=63;66) | 85.9 titer |
| Placebo-Pandemrix-Fluarix Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Cal/7/09 (N=63;66) | 223.8 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Uru/716/07 (N=63;66) | 62.4 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Cal/7/09 (N=64;67) | 7.4 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Cal/7/09 (N=64;67) | 13.8 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 109.6 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 74.1 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 25.7 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Bri/59/07 (N=64;67) | 20.8 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Bri/59/07 (N=64;67) | 64.0 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Bri/59/07 (N=64;67) | 56.5 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Bri/59/07 (N=63;66) | 49.8 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 B/Bri/60/08 (N=64;67) | 135.6 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 B/Bri/60/08 (N=64;67) | 351.2 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 B/Bri/60/08 (N=64;67) | 291.5 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 B/Bri/60/08 (N=63;66) | 273.3 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Uru/716/07 (N=64;67) | 22.5 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Uru/716/07 (N=64;67) | 100.9 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Uru/716/07 (N=64;67) | 69.2 titer |
| Fluarix-Pandemrix-Placebo Group | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Cal/7/09 (N=63;66) | 174.0 titer |
Secondary
Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).
Time frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 57 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 48 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 19 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Bri/56/07 (N=63;67) | 9 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 B/Bri/60/08 (N=63;67) | 4 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Uru/716/07 (N=63;67) | 25 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 B/Bri/60/08 (N=63;67) | 18 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 43 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Bri/56/07 (N=63;67) | 21 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 39 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Uru/716/07 (N=63;67) | 34 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 11 subjects |
Secondary
Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Time frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Cal/7/09 (N=64;67) | 9 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Bri/59/07 (N=63;66) | 50 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 28 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 B/Bri/60/08 (N=64;67) | 61 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 B/Bri/60/08 (N=64;67) | 61 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Cal/7/09 (N=63;66) | 63 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 B/Bri/60/08 (N=64;67) | 64 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Bri/59/07 (N=64;67) | 25 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 B/Bri/60/08 (N=63;66) | 63 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 60 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Uru/716/07 (N=64;67) | 30 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Bri/59/07 (N=64;67) | 26 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Uru/716/07 (N=64;67) | 29 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 52 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Uru/716/07 (N=64;67) | 30 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Bri/59/07 (N=64;67) | 30 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Uru/716/07 (N=63;66) | 54 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Cal/7/09 (N=64;67) | 9 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Uru/716/07 (N=63;66) | 46 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Cal/7/09 (N=64;67) | 4 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Cal/7/09 (N=64;67) | 12 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 58 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Cal/7/09 (N=63;66) | 65 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 53 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 19 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Bri/59/07 (N=64;67) | 21 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Bri/59/07 (N=64;67) | 50 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Bri/59/07 (N=64;67) | 47 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Bri/59/07 (N=63;66) | 42 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 B/Bri/60/08 (N=64;67) | 63 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 B/Bri/60/08 (N=64;67) | 67 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 B/Bri/60/08 (N=64;67) | 67 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 B/Bri/60/08 (N=63;66) | 66 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Uru/716/07 (N=64;67) | 22 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Uru/716/07 (N=64;67) | 57 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Uru/716/07 (N=64;67) | 47 subjects |
Secondary
Number of Subjects With AEs of Specific Interest
Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.
Time frame: During the entire study period (Day 0-364)
Population: The analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With AEs of Specific Interest | 0 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With AEs of Specific Interest | 1 subjects |
Secondary
Number of Subjects With 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: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination
Time frame: During 21 days (Day 0-20) after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any | 33 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 | 4 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related | 14 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any | 37 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 | 10 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related | 9 subjects |
Secondary
Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
The cut-off was a titer of 1:10 and this titer was considered as seropositivity. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.
Time frame: At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Cal/7/09 (N=64;67) | 22 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Cal/7/09 (N=64;67) | 26 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 64 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Cal/7/09 (N=63;66) | 63 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 60 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 57 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Bri/59/07 (N=64;67) | 57 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Bri/59/07 (N=64;67) | 56 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Bri/59/07 (N=64;67) | 62 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Bri/59/07 (N=63;66) | 62 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 B/Bri/60/08 (N=64;67) | 64 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 B/Bri/60/08 (N=64;67) | 64 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 B/Bri/60/08 (N=64;67) | 64 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 B/Bri/60/08 (N=63;66) | 63 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Uru/716/07 (N=64;67) | 51 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Uru/716/07 (N=64;67) | 51 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Uru/716/07 (N=64;67) | 57 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Uru/716/07 (N=63;66) | 63 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 B/Bri/60/08 (N=63;66) | 66 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Cal/7/09 (N=64;67) | 21 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Bri/59/07 (N=63;66) | 66 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Cal/7/09 (N=64;67) | 50 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Uru/716/07 (N=63;66) | 65 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 67 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 B/Bri/60/08 (N=64;67) | 67 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63 A/Cal/7/09 (N=63;66) | 66 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Uru/716/07 (N=64;67) | 52 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 63 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 B/Bri/60/08 (N=64;67) | 67 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 60 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Uru/716/07 (N=64;67) | 66 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day -21 A/Bri/59/07 (N=64;67) | 58 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 B/Bri/60/08 (N=64;67) | 67 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Bri/59/07 (N=64;67) | 67 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 0 A/Uru/716/07 (N=64;67) | 66 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 42 A/Bri/59/07 (N=64;67) | 67 subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include 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: During the entire study period (Day 0-364)
Population: The analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Serious Adverse Events (SAEs) | 11 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 14 subjects |
Secondary
Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).
Time frame: During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix
Population: The analysis was performed on the Total Vaccinated cohort on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Fatigue | 22 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Pain | 49 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Redness | 11 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Swelling | 8 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Headache | 23 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Joint pain at other location | 20 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Muscle aches | 23 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Shivering | 14 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Sweating | 12 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Temperature | 2 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Shivering | 15 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Fatigue | 18 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Swelling | 11 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Joint pain at other location | 13 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Pain | 43 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Temperature | 3 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Redness | 10 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Muscle aches | 22 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Sweating | 13 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Headache | 19 subjects |
Secondary
Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)
Time frame: During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix
Population: The analysis was performed on the Total Vaccinated cohort on subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | pain Day -21 (N=72;72) | 5 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | redness Day -21 (N=72;72) | 2 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | swelling Day -21 (N=72;72) | 0 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | pain Day 42 (N=69;71) | 17 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | redness Day 42 (N=69;71) | 1 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | swelling Day 42 (N=69;71) | 2 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | fatigue Day -21 (N=72;72) | 9 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | headache Day -21 (N=72;72) | 5 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | joint pain at other location Day -21 (N=72;72) | 7 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | muscle aches Day -21 (N=72;72) | 4 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | shivering Day -21 (N=72;72) | 2 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | sweating Day -21 (N=72;72) | 5 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | temperature Day -21 (N=72;72) | 0 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | temperature Day 42 (N=69;71) | 0 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | fatigue Day 42 (N=69;71) | 10 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | headache Day 42 (N=69;71) | 10 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | joint pain at other location Day 42 (N=69;71) | 8 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | muscle aches Day 42 (N=69;71) | 7 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | shivering Day 42 (N=69;71) | 3 subjects |
| Placebo-Pandemrix-Fluarix Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | sweating Day -21 (N=69;71) | 3 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | headache Day 42 (N=69;71) | 8 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | pain Day -21 (N=72;72) | 12 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | shivering Day -21 (N=72;72) | 4 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | redness Day -21 (N=72;72) | 1 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | shivering Day 42 (N=69;71) | 3 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | swelling Day -21 (N=72;72) | 1 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | sweating Day -21 (N=72;72) | 6 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | pain Day 42 (N=69;71) | 4 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | joint pain at other location Day 42 (N=69;71) | 6 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | redness Day 42 (N=69;71) | 0 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | temperature Day -21 (N=72;72) | 1 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | swelling Day 42 (N=69;71) | 0 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | temperature Day 42 (N=69;71) | 0 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | fatigue Day -21 (N=72;72) | 7 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | muscle aches Day 42 (N=69;71) | 5 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | headache Day -21 (N=72;72) | 10 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | fatigue Day 42 (N=69;71) | 4 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | joint pain at other location Day -21 (N=72;72) | 2 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | sweating Day -21 (N=69;71) | 4 subjects |
| Fluarix-Pandemrix-Placebo Group | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | muscle aches Day -21 (N=72;72) | 6 subjects |
Secondary
Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
For the definition of seroconversion factor, please refer to the primary outcome measure. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).
Time frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 16.0 fold increase |
| Placebo-Pandemrix-Fluarix Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 10.9 fold increase |
| Placebo-Pandemrix-Fluarix Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 3.8 fold increase |
| Placebo-Pandemrix-Fluarix Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Bri/56/07 (N=63;67) | 1.7 fold increase |
| Placebo-Pandemrix-Fluarix Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 B/Bri/60/08 (N=63;67) | 1.6 fold increase |
| Placebo-Pandemrix-Fluarix Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Uru/716/07 (N=63;67) | 3.1 fold increase |
| Fluarix-Pandemrix-Placebo Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 B/Bri/60/08 (N=63;67) | 2.6 fold increase |
| Fluarix-Pandemrix-Placebo Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 21 A/Cal/7/09 (N=64;67) | 7.9 fold increase |
| Fluarix-Pandemrix-Placebo Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Bri/56/07 (N=63;67) | 3.1 fold increase |
| Fluarix-Pandemrix-Placebo Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 6 A/Cal/7/09 (N=60;63) | 5.2 fold increase |
| Fluarix-Pandemrix-Placebo Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Day 63/Day 0 A/Uru/716/07 (N=63;67) | 4.5 fold increase |
| Fluarix-Pandemrix-Placebo Group | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Month 12 A/Cal/7/09 (N=60;64) | 1.8 fold increase |