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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' Fluarixâ„¢ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.
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 Fluarixâ„¢ and placebo vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pandemrix+Fluarix and Pandemrix+Placebo | Experimental | Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarixâ„¢ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
|
| Pandemrix+Placebo and Pandemrix+Fluarix | Experimental | 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 Fluarixâ„¢ on Day 21 intramuscularly in the deltoid region of the dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pandemrix (Influenza vaccine GSK2340272A) | Biological | Intramuscular injection, 2 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 0, 21, 42, 182, 364 |
| Number of Seroconverted Subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Eskilstuna | SE-631 88 | Sweden | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22885014 | Derived | Peeters M, Regner S, Vaman T, Devaster JM, Rombo L. Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials. Vaccine. 2012 Oct 5;30(45):6483-91. doi: 10.1016/j.vaccine.2012.07.081. Epub 2012 Aug 9. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113525 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Fluarixâ„¢ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| FG001 | 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 Fluarixâ„¢ on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 Fluarixâ„¢ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of 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. | 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. | Posted | Number | subjects | 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) |
|
Not provided
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Fluarixâ„¢ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain after Pandemrix | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
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| ID | Term |
|---|---|
| C556153 | pandemrix |
| C510903 | fluarix |
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| Fluarixâ„¢ | Biological | Intramuscular injection, 1 dose |
|
|
| Placebo | Biological | Intramuscular injection, 1 dose |
|
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. |
| at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 |
| 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. | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 |
| 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. | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 |
| 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. | Days 0, 21, 42, 182, 364 |
| 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). | Within 7 days (Day 0-Day 6) after each vaccination |
| 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 | From Day 0 to Day 83 |
| Number of Subjects With Adverse Events of Specific Interest | Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders. | From Day 0 to Day 364 |
| 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. | From Day 0 to Day 364 |
| Örebro |
| SE-703 62 |
| Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113525 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113525 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113525 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113525 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113525 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113525 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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 Fluarixâ„¢ on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarixâ„¢ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. |
| OG001 | 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 Fluarixâ„¢ on Day 21 intramuscularly in the deltoid region of the dominant arm. |
|
|
| 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. | 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. | Posted | Number | subjects | 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) |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | 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) |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 0, 21, 42, 182, 364 |
|
|
|
| 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. | 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. | Posted | Number | subjects | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 |
|
|
|
| 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. | 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. | Posted | Number | subjects | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 |
|
|
|
| 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. | 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. | Posted | Number | subjects | Days 0, 21, 42, 182, 364 |
|
|
|
| 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). | Analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | Within 7 days (Day 0-Day 6) after each vaccination |
|
|
|
| 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 | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | From Day 0 to Day 83 |
|
|
|
| Secondary | Number of Subjects With Adverse Events of Specific Interest | Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders. | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | From Day 0 to Day 364 |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | From Day 0 to Day 364 |
|
|
|
| 2 |
| 84 |
| 71 |
| 84 |
| EG001 | 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 Fluarixâ„¢ on Day 21 intramuscularly in the deltoid region of the dominant arm. | 3 | 84 | 78 | 84 |
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | Non-systematic Assessment |
|
| Pain after Fluarix | General disorders | Systematic Assessment |
|
| Pain after Placebo | General disorders | Systematic Assessment |
|
| Redness after Pandemrix | General disorders | Systematic Assessment |
|
| Swelling after Pandemrix | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Joint pain at other location | General disorders | Systematic Assessment |
|
| Muscle aches | General disorders | Systematic Assessment |
|
| Shivering | General disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| A/Uru/07 |
|
| B/Bri/08 |
|
| A/Uru/07 |
|
| A/Bri/07 |
|
| A/Cal/09 Day 42 (N=83;84) |
|
| A/Cal/09 Day 182 (N=84;84) |
|
| A/Cal/09 Day 364 (N=84;84) |
|
| A/Bri/07 Day 0 (N=83;84) |
|
| A/Bri/07 Day 21/Day 42 (N=83;84) |
|
| A/Bri/07 Day 182 (N=84;84) |
|
| A/Bri/07 Day 364 (N=84;84) |
|
| A/Uru/07 Day 0 (N=83;84) |
|
| A/Uru/07 Day 21/Day 42 (N=83;84) |
|
| A/Uru/07 Day 182 (N=84;84) |
|
| A/Uru/07 Day 364 (N=84;84) |
|
| B/Bri/08 Day 0 (N=83;84) |
|
| B/Bri/08 Day 21/Day 42 (N=83;84) |
|
| B/Bri/08 Day 182 (N=84;84) |
|
| B/Bri/08 Day 364 (N=84;84) |
|
| A/Cal/09 Day 364 (N=84;84) |
|
| A/Bri/07 Day 182 (N=84;84) |
|
| A/Bri/07 Day 364 (N=84;84) |
|
| A/Uru/07 Day 182 (N=84;84) |
|
| A/Uru/07 Day 364 (N=84;84) |
|
| B/Bri/08 Day 182 (N=84;84) |
|
| B/Bri/08 Day 364 (N=84;84) |
|
| A/Cal/09 Day 182 (N=84;84) |
|
| A/Cal/09 Day 364 (N=84;84) |
|
| A/Bri/07 Day 0 (N=83;84) |
|
| A/Bri/07 Day 182 (N=84;84) |
|
| A/Bri/07 Day 364 (N=84;84) |
|
| A/Uru/07 Day 0 (N=83;84) |
|
| A/Uru/07 Day 182 (N=84;84) |
|
| A/Uru/07 Day 364 (N=84;84) |
|
| B/Bri/08 Day 0 (N=83;84) |
|
| B/Bri/08 Day 182 (N=84;84) |
|
| B/Bri/08 Day 364 (N=84;84) |
|
| A/Cal/09 Day 364 (N=84;84) |
|
| A/Bri/07 Day 182 (N=84;84) |
|
| A/Bri/07 Day 364 (N=84;84) |
|
| A/Uru/07 Day 182 (N=84;84) |
|
| A/Uru/07 Day 364 (N=84;84) |
|
| B/Bri/08 Day 182 (N=84;84) |
|
| B/Bri/08 Day 364 (N=84;84) |
|
| A/Cal/09 Day 42 (N=83;84) |
|
| A/Cal/09 Day 182 (N=84;84) |
|
| A/Cal/09 Day 364 (N=84;84) |
|
| A/Bri/07 Day 0 (N=83;84) |
|
| A/Bri/07 Day 21/Day 42 (N=83;84) |
|
| A/Bri/07 Day 182 (N=84;84) |
|
| A/Bri/07 Day 364 (N=84;84) |
|
| A/Uru/07 Day 0 (N=83;84) |
|
| A/Uru/07 Day 21/Day 42 (N=83;84) |
|
| A/Uru/07 Day 182 (N=84;84) |
|
| A/Uru/07 Day 364 (N=84;84) |
|
| B/Bri/08 Day 0 (N=83;84) |
|
| B/Bri/08 Day 21/Day 42 (N=83;84) |
|
| B/Bri/08 Day 182 (N=84;84) |
|
| B/Bri/08 Day 364 (N=84;84) |
|
| Pain after Placebo |
|
| Redness after Pandemrix |
|
| Redness after Fluarix |
|
| Redness after Placebo |
|
| Swelling after Pandemrix |
|
| Swelling after Fluarix |
|
| Swelling after Placebo |
|
| Fatigue |
|
| Headache |
|
| Joint pain at other location |
|
| Muscle aches |
|
| Shivering |
|
| Sweating |
|
| Temperature |
|