Influenza
Conditions
Keywords
GSK Bio's influenza vaccine GSK2340272A, Influenza infection
Brief summary
The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.
Detailed description
The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A. The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.
Interventions
BIOLOGICALPandemrix (Influenza vaccine GSK2340272A)
Intramuscular injection, 2 doses
BIOLOGICALFluarix™
Intramuscular injection, 1 dose
BIOLOGICALPlacebo
Intramuscular injection, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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. * Access to a consistent means of telephone contact.
Exclusion criteria
* Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal 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 vaccine GSK2340272A. * Use of any investigational or non-registered product (drug or vaccine) 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 (i.e., no treatment) 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 oral temperature \>= 37.5°C, or acute symptoms greater than mild severity on the scheduled date of first vaccination. * Diagnosed with cancer, or treatment for cancer, within 3 years. * 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. * 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 anti-platelet 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 as determined by medical history and physical examination. * 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. * 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 |
|---|---|---|
| Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group) | A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
| Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group) | A seroprotected subject was a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
| Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group) | The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 | The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
| Number of Subjects With Titers Equal to or Above Titer 1:10 | Days 0, 21, 42, 182, 364 | The cut-off 1:10 was considered as seropositivity. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
| Number of Subjects With Solicited Local and General Symptoms | Within 7 days (Day 0-Day 6) after each vaccination | Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature \>= 38.0 degrees Celsius). |
| Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | Days 0, 21, 42, 182, 364 | Titers are expressed as GMTs. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
| Number of Subjects With Adverse Events of Specific Interest | From Day 0 to Day 364 | Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Day 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 Unsolicited Adverse Events (AEs) | From Day 0 to Day 83 | 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 |
| Number of Seroconverted Subjects | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 | A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
| Number of Seroprotected Subjects | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 | A seroprotected subject is a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. | 84 |
| Pandemrix+Placebo and Pandemrix+Fluarix Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm. | 84 |
| Total | 168 |
Baseline characteristics
| Characteristic | Pandemrix+Fluarix and Pandemrix+Placebo | Pandemrix+Placebo and Pandemrix+Fluarix | Total |
|---|---|---|---|
| Age, Continuous | 68.9 Years STANDARD_DEVIATION 4.63 | 69.1 Years STANDARD_DEVIATION 4.7 | 69.0 Years STANDARD_DEVIATION 4.65 |
| Sex: Female, Male Female | 42 Participants | 47 Participants | 89 Participants |
| Sex: Female, Male Male | 42 Participants | 37 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 71 / 84 | 78 / 84 |
| serious Total, serious adverse events | 2 / 84 | 3 / 84 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Cal/09 | 33.1 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | B/Bri/08 | 4.7 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Uru/07 | 4.2 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Bri/07 | 3.5 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Bri/07 | 2.7 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Cal/09 | 32.2 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Uru/07 | 3.0 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix | B/Bri/08 | 2.1 ratio |
Primary
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Cal/09 | 79 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | B/Bri/08 | 40 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Uru/07 | 36 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Bri/07 | 31 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Bri/07 | 23 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Cal/09 | 82 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Uru/07 | 23 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | B/Bri/08 | 22 subjects |
Primary
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A seroprotected subject was a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Cal/09 | 82 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Bri/07 | 57 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Uru/07 | 65 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | B/Bri/08 | 83 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | B/Bri/08 | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Cal/09 | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Uru/07 | 54 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix | A/Bri/07 | 52 subjects |
Secondary
Geometric Mean Fold Rise (GMFR)
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | A/Cal/09 Day 182 (N=84;84) | 9.6 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | A/Uru/07 Day 182 (N=84;84) | 2.0 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | A/Bri/07 Day 182 (N=84;84) | 2.5 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | A/Uru/07 Day 364 (N=84;84) | 1.6 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | A/Cal/09 Day 364 (N=84;84) | 3.9 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | B/Bri/08 Day 182 (N=84;84) | 4.4 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | A/Bri/07 Day 364 (N=84;84) | 1.9 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | B/Bri/08 Day 364 (N=84;84) | 2.1 ratio |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Fold Rise (GMFR) | A/Cal/09 Day 21 (N=83;84) | 18.7 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | B/Bri/08 Day 364 (N=84;84) | 1.0 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | A/Cal/09 Day 21 (N=83;84) | 19.8 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | A/Cal/09 Day 182 (N=84;84) | 9.9 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | A/Cal/09 Day 364 (N=84;84) | 4.0 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | A/Bri/07 Day 182 (N=84;84) | 2.3 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | A/Bri/07 Day 364 (N=84;84) | 1.8 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | A/Uru/07 Day 182 (N=84;84) | 1.8 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | A/Uru/07 Day 364 (N=84;84) | 1.4 ratio |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Fold Rise (GMFR) | B/Bri/08 Day 182 (N=84;84) | 1.9 ratio |
Secondary
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
Titers are expressed as GMTs. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: Days 0, 21, 42, 182, 364
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 21 (N=83;84) | 138.8 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 0 (N=83;84) | 17.9 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 0 (N=83;84) | 15.2 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 21/Day 42 (N=83;84) | 74.8 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 182 (N=84;84) | 71.2 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 182 (N=84;84) | 35.9 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 21/Day 42 (N=83;84) | 53.6 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 364 (N=84;84) | 28.7 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 42 (N=83;84) | 246.1 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 0 (N=83;84) | 49.9 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 182 (N=84;84) | 37.9 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 21/Day 42 (N=83;84) | 235.0 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 364 (N=84;84) | 29.1 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 182 (N=84;84) | 220.7 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 364 (N=84;84) | 29.4 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 364 (N=84;84) | 104.6 titer |
| Pandemrix+Fluarix and Pandemrix+Placebo | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 0 (N=83;84) | 7.4 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 364 (N=84;84) | 112.7 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 0 (N=83;84) | 8.5 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 21 (N=83;84) | 168.2 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 42 (N=83;84) | 273.6 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 182 (N=84;84) | 84.0 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Cal/09 Day 364 (N=84;84) | 34.4 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 0 (N=83;84) | 16.0 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 21/Day 42 (N=83;84) | 42.5 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 182 (N=84;84) | 36.8 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Bri/07 Day 364 (N=84;84) | 28.8 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 0 (N=83;84) | 19.7 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 21/Day 42 (N=83;84) | 59.7 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 182 (N=84;84) | 35.0 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | A/Uru/07 Day 364 (N=84;84) | 27.7 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 0 (N=83;84) | 115.5 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 21/Day 42 (N=83;84) | 246.7 titer |
| Pandemrix+Placebo and Pandemrix+Fluarix | Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains | B/Bri/08 Day 182 (N=84;84) | 222.5 titer |
Secondary
Number of Seroconverted Subjects
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | A/Bri/07 Day 182 (N=84;84) | 18 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | A/Bri/07 Day 364 (N=84;84) | 5 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | A/Uru/07 Day 182 (N=84;84) | 13 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | A/Uru/07 Day 364 (N=84;84) | 7 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | B/Bri/08 Day 182 (N=84;84) | 40 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | B/Bri/08 Day 364 (N=84;84) | 19 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | A/Cal/09 Day 21 (N=83;84) | 73 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | A/Cal/09 Day 182 (N=84;84) | 64 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroconverted Subjects | A/Cal/09 Day 364 (N=84;84) | 25 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | A/Cal/09 Day 182 (N=84;84) | 69 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | B/Bri/08 Day 364 (N=84;84) | 3 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | A/Bri/07 Day 364 (N=84;84) | 8 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | A/Bri/07 Day 182 (N=84;84) | 13 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | A/Uru/07 Day 182 (N=84;84) | 9 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | A/Cal/09 Day 21 (N=83;84) | 78 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | A/Uru/07 Day 364 (N=84;84) | 6 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | A/Cal/09 Day 364 (N=84;84) | 30 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroconverted Subjects | B/Bri/08 Day 182 (N=84;84) | 13 subjects |
Secondary
Number of Seroprotected Subjects
A seroprotected subject is a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Bri/07 Day 182 (N=84;84) | 48 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Cal/09 Day 182 (N=84;84) | 67 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Bri/07 Day 364 (N=84;84) | 36 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Uru/07 Day 364 (N=84;84) | 36 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Uru/07 Day 0 (N=83;84) | 29 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Cal/09 Day 364 (N=84;84) | 32 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Uru/07 Day 182 (N=84;84) | 44 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | B/Bri/08 Day 0 (N=83;84) | 56 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Cal/09 Day 21 (N=83;84) | 74 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | B/Bri/08 Day 182 (N=84;84) | 84 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Bri/07 Day 0 (N=83;84) | 22 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | B/Bri/08 Day 364 (N=84;84) | 78 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Seroprotected Subjects | A/Cal/09 Day 0 (N=83;84) | 6 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | B/Bri/08 Day 364 (N=84;84) | 77 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Uru/07 Day 364 (N=84;84) | 40 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Cal/09 Day 0 (N=83;84) | 7 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Cal/09 Day 21 (N=83;84) | 81 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Cal/09 Day 182 (N=84;84) | 75 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Cal/09 Day 364 (N=84;84) | 40 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Bri/07 Day 0 (N=83;84) | 17 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Bri/07 Day 182 (N=84;84) | 44 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Bri/07 Day 364 (N=84;84) | 34 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Uru/07 Day 0 (N=83;84) | 31 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | B/Bri/08 Day 0 (N=83;84) | 78 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | B/Bri/08 Day 182 (N=84;84) | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Seroprotected Subjects | A/Uru/07 Day 182 (N=84;84) | 43 subjects |
Secondary
Number of Subjects With Adverse Events of Specific Interest
Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.
Time frame: From Day 0 to Day 364
Population: The analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Adverse Events of Specific Interest | 0 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Adverse Events of Specific Interest | 0 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: From Day 0 to Day 364
Population: The analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Serious Adverse Events (SAEs) | 2 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Serious Adverse Events (SAEs) | 3 subjects |
Secondary
Number of Subjects With Solicited Local and General Symptoms
Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature \>= 38.0 degrees Celsius).
Time frame: Within 7 days (Day 0-Day 6) after each vaccination
Population: Analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Pain after Pandemrix | 64 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Pain after Fluarix | 18 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Pain after Placebo | 0 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Redness after Pandemrix | 15 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Redness after Fluarix | 0 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Redness after Placebo | 0 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Swelling after Pandemrix | 22 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Swelling after Fluarix | 3 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Swelling after Placebo | 0 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Fatigue | 25 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Headache | 23 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Joint pain at other location | 13 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Muscle aches | 18 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Shivering | 12 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Sweating | 2 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Solicited Local and General Symptoms | Temperature | 3 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Temperature | 0 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Pain after Pandemrix | 74 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Swelling after Placebo | 2 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Pain after Fluarix | 26 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Muscle aches | 26 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Pain after Placebo | 8 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Fatigue | 27 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Redness after Pandemrix | 19 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Sweating | 8 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Redness after Fluarix | 1 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Headache | 23 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Redness after Placebo | 0 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Shivering | 16 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Swelling after Pandemrix | 27 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Joint pain at other location | 17 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Solicited Local and General Symptoms | Swelling after Fluarix | 4 subjects |
Secondary
Number of Subjects With Titers Equal to or Above Titer 1:10
The cut-off 1:10 was considered as seropositivity. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time frame: Days 0, 21, 42, 182, 364
Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 21 (N=83;84) | 82 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 0 (N=83;84) | 58 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 0 (N=83;84) | 59 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 21/Day 42 (N=83;84) | 79 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 182 (N=84;84) | 84 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 182 (N=84;84) | 77 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 21/Day 42 (N=83;84) | 82 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 364 (N=84;84) | 76 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 42 (N=83;84) | 83 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 0 (N=83;84) | 76 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 182 (N=84;84) | 83 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 21/Day 42 (N=83;84) | 83 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 364 (N=84;84) | 78 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 182 (N=84;84) | 84 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 364 (N=84;84) | 82 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 364 (N=84;84) | 84 subjects |
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 0 (N=83;84) | 20 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 364 (N=84;84) | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 0 (N=83;84) | 32 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 21 (N=83;84) | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 42 (N=83;84) | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 182 (N=84;84) | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Cal/09 Day 364 (N=84;84) | 81 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 0 (N=83;84) | 68 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 21/Day 42 (N=83;84) | 82 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 182 (N=84;84) | 83 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Bri/07 Day 364 (N=84;84) | 83 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 0 (N=83;84) | 57 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 21/Day 42 (N=83;84) | 80 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 182 (N=84;84) | 73 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | A/Uru/07 Day 364 (N=84;84) | 65 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 0 (N=83;84) | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 21/Day 42 (N=83;84) | 84 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Titers Equal to or Above Titer 1:10 | B/Bri/08 Day 182 (N=84;84) | 84 subjects |
Secondary
Number of Subjects With 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
Time frame: From Day 0 to Day 83
Population: The analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Number of Subjects With Unsolicited Adverse Events (AEs) | 41 subjects |
| Pandemrix+Placebo and Pandemrix+Fluarix | Number of Subjects With Unsolicited Adverse Events (AEs) | 41 subjects |