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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002712-25 |
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Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T/P-A | Experimental | One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22 |
|
| A/P-T | Experimental | One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22. |
|
| A/S-A | Active Comparator | One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22. |
|
| T/P-A (V2 blood draw) | Experimental | One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by a blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22. |
|
| A/P-T (V2 blood draw) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine | Biological | Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3. |
| Measure | Description | Time Frame |
|---|---|---|
| To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43. | The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence. The statistical analysis was done based on the GMRs. | up to day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination | Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATRIUM Gesundheitszentrum; | Holzkirchen | 83607 | Germany | |||
| International Medicine & Public Health Dept. of Infect. Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24047817 | Derived | Herbinger KH, von Sonnenburg F, Nothdurft HD, Perona P, Borkowski A, Fragapane E, Nicolay U, Clemens R. A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59(R): adjuvanted, pre-pandemic, A/H5N1 vaccine and trivalent seasonal influenza vaccine in healthy adults. Hum Vaccin Immunother. 2014;10(1):92-9. doi: 10.4161/hv.26495. Epub 2013 Sep 20. |
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All subjects were included in the trial. The data entered is for the overall study.
Participants were enrolled at 2 sites in Germany
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| ID | Title | Description |
|---|---|---|
| FG000 | T/P-A | one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22 |
| FG001 | A/P-T |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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One dose of the Aflunov(A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by additional blood draw at visit 2 (V2) prior to the Tetravalent influenza vaccination (T) on day 22.
|
| A/S-A (V2 blood draw) | Active Comparator | One dose of Aflunov (A)and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed by an additional blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22. |
|
| Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1 | Biological | Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3. |
|
| Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine | Biological | Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3. |
|
| Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1 | Biological | Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3. |
|
| Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine | Biological | Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3. |
|
| MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine | Biological | Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3. |
|
| Up to 7 days after 1st vaccination |
| Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination | Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. | Up to 7 days after 2nd vaccination |
| Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations. | Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. | 7 days after 1st and 2nd vaccinations each |
| Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain | Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion. Significant increase in antibody titer is defined as at least a four-fold increase from non-negative pre-vaccination serum (≥ 10) for HI or a 50% increase in area for SRH. Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH) | up to day 43 |
| Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2 | Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay. | Up to 43 days |
| Antibody Response Determined by HI and MN Assay. | Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay. | Up to 43 days |
| Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination. | The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects. Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC. | Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43) |
| Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit | Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with: Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)]. The change in frequency of T-cells was measured. | Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43) |
| Munich |
| 80799 |
| Germany |
one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
| FG002 | A/S-A | one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T/P-A | one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22 |
| BG001 | A/P-T | one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22 |
| BG002 | A/S-A | one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | A total of 601 subjects were enrolled and randomized, 199 to the T/P-A group, 203 to the A/P-T group and 199 to the A/S-A group. One subject in the A/S-A group did not meet entry criteria and so did not receive any vaccination. | Number | participants |
| |||||||||||||||
| Sex/Gender, Customized | Analysis was done on Full Analysis Set | Number | participants |
|
| 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 | To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43. | The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence. The statistical analysis was done based on the GMRs. | The analysis was done on Per Protocol Set (PPS) | Posted | Geometric Mean | 95% Confidence Interval | Area (mm^2) | up to day 43 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination | Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently. | The analysis was performed on Safety Population | Posted | Number | Participants | Up to 7 days after 1st vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination | Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. | The analysis was performed on Safety Population | Posted | Number | Participants | Up to 7 days after 2nd vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations. | Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. | The analysis was performed on Per Protocol Safety Population | Posted | Number | Participants | 7 days after 1st and 2nd vaccinations each |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain | Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion. Significant increase in antibody titer is defined as at least a four-fold increase from non-negative pre-vaccination serum (≥ 10) for HI or a 50% increase in area for SRH. Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH) | The population was analyzed on per protocol set. | Posted | Number | 95% Confidence Interval | Percentage of subjects | up to day 43 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2 | Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay. | The analysis was done on Per Protocol Set | Posted | Number | 95% Confidence Interval | Percentages of subjects | Up to 43 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Antibody Response Determined by HI and MN Assay. | Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay. | The population was analyzed on Per protocol set | Posted | Mean | 95% Confidence Interval | titers | Up to 43 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination. | The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects. Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC. | The analysis was done on Full analysis set | Posted | Mean | 95% Confidence Interval | Percentages of B-cell antibodies | Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit | Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with: Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)]. The change in frequency of T-cells was measured. | Analysis was done on full analysis set | Posted | Mean | 95% Confidence Interval | Mean cells per million total cells | Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43) |
|
Throughout the entire study period
Data provided in the "other Adverse Events (>5%)" includes solicited local and systemic reactions along with unsolicited Adverse Events (AEs) that persisted for more than 7 days after each study vaccination. Events not otherwise noted as occurring in the >= 61 year old population were limited to the <= 60 year old population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T/P-A | one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22 | 2 | 199 | 190 | 199 | ||
| EG001 | A/P-T | one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22 | 3 | 203 | 185 | 203 | ||
| EG002 | A/S-A | one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22 | 4 | 198 | 183 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Detachment | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intestinal Polyp | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Endoscopic Retrograde Cholangiopancreatography | Investigations | MedDRA | Non-systematic Assessment |
| |
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Intracranial Aneurysm | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Bulimia Nervosa | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depression Suicidal | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Eye Operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Hysterosalpingo-Oophorectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Lymphadenectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Injection Site Haemorrhage | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection Site Induration | General disorders | MedDRA | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment | In subjects >= 61 years of age. |
|
| Injection Site Haematoma | General disorders | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Injection Site Haemorrhage | General disorders | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Injection Site Pain | General disorders | MedDRA | Systematic Assessment | In subjects >= 61 years of age. |
|
| Malaise | General disorders | MedDRA | Systematic Assessment | In subjects >= 61 years of age. |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Tinea Pedis | Infections and infestations | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | In subjects >= 61 years of age. |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | In subjects >= 61 years of age. |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment | In subjects >= 61 years of age. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | In subjects >= 61 years of age. |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Wisdom teeth Removal | Surgical and medical procedures | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment | In subjects >= 61 years of age. |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
Not provided
Not provided
| ≥ 61 Years |
|
| Male (≤60 years of age) |
|
| Female (≥61 years of age) |
|
| Male (≥61 years of age) |
|
|
| Day 43 (N=181, 189, 189) |
|
| (On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratios | 1.01 | 2-Sided | 96.67 | 0.91 | 1.12 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
| (On day 1)Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratio | 0.89 | 2-Sided | 96.67 | 0.80 | 0.99 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
| (On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratios | 1.19 | 2-Sided | 96.67 | 0.74 | 1.93 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
| (On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratios | 0.85 | 2-Sided | 96.67 | 0.52 | 1.38 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
| (On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratios | 0.71 | 2-Sided | 96.67 | 0.44 | 1.15 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
| (On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratios | 1.14 | 2-Sided | 96.67 | 1.01 | 1.30 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
| (On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratios | 1.05 | 2-Sided | 96.67 | 0.93 | 1.19 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
| (On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0]. | ANOVA | P-values were not calculated for the equivalence tests due to lack of appropriate statistical software | Geometric Mean Ratios | 0.92 | 2-Sided | 96.67 | 0.81 | 1.04 | Yes | Non-Inferiority or Equivalence | To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected. |
Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine(T) on day 22
| OG003 | A/P-T: In Arm Receiving Placebo (P) | Local reactions after first vaccination in arm receiving Placebo in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22 |
| OG004 | A/S-A: In Arm Receiving Aflunov (A) | Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) bon day 22 |
| OG005 | A/S-A: In Arm Receiving Seasonal Influenza Vaccine (S) | Local reactions after first vaccination in arm receiving seasonal influenza vaccination in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22 |
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| OG003 | T/P-A: After 2nd Vaccination | Systemic reactions after second vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A) |
| OG004 | A/P-T: After 2nd Vaccination | Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T) |
| OG005 | A/S-A: After 2nd Vaccination | Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A) |
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one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
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| OG002 |
| A/S-A |
one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22 |
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| OG002 |
| A/S-A |
one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22 |
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