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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003871-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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The present study, phase III, randomized, controlled, observer-blind, multicenter study, will evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a population of healthy adult and elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIV + aH5N1 | Experimental | First dose of the non-adjuvanted trivalent influenza virus vaccine (TIV) followed by two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1). |
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| PL + aTIV | Active Comparator | First dose of placebo (PL-saline) followed by two doses of the adjuvanted trivalent influenza virus vaccine (aTIV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (PL) | Biological | One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. | To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group. | Up to 6 days after each vaccination. |
| Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine. | To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of <=0.1%, & uncommon AEs in elderly, i.e. occurring at a frequency of <=1% of subjects. | Upto Day 224 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. | To evaluate the safety and tolerability profile of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (aTIV), in terms of the number of subjects who reported local and systemic reactions up to 6 days after each vaccination per vaccination group. |
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Inclusion Criteria:
Subjects 18 years of age and older who were mentally competent and who had signed an informed consent form after having received a detailed explanation of the study protocol;
In good health as determined by:
Able to understand and comply with all study procedures and to complete study diaries, could be contacted, and were available for study visits;
Exclusion Criteria:
Receipt of another investigational agent within 4 weeks;
Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
Receipt of influenza vaccination for current season 2008/2009;
Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) within the past 7 days;
Experienced fever (defined as axillary temperature ≥38.0°C) within 7 days prior to Visit 1;
Pregnant or breastfeeding;
Females of childbearing potential who were sexually active and had not used or did not plan or refused to use an acceptable method of birth control during the active phase of the study (at least up to three weeks after last vaccine injection);
Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis); diabetes mellitus type I and type II; diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas or infections; advanced arteriosclerotic disease; severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and 4; acute or progressive hepatic disease and renal disease; congestive heart failure; Body Mass Index (BMI) ≥35 kg/m2 where BMI reflects obesity and not high muscle mass;
History of progressive or severe neurologic disorders, of any neurological symptoms or signs, or anaphylactic shock following administration of any study vaccine;
Bleeding diathesis;
Surgery planned during the study period;
Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccines;
Known or suspected impairment/alteration of immune function, for example, resulting from:
Receipt of non study vaccines (with the exception of post-exposure vaccination in a medical emergency, e.g. hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
History of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;
Members of research staff and their relatives;
Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere Vaccine Research Clinic (15 sites) | Tampere | 33100 | Finland | |||
| 12 Sites |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22192847 | Result | Vesikari T, Forsten A, Herbinger KH, Cioppa GD, Beygo J, Borkowski A, Groth N, Bennati M, von Sonnenburg F. Safety and immunogenicity of an MF59((R))-adjuvanted A/H5N1 pre-pandemic influenza vaccine in adults and the elderly. Vaccine. 2012 Feb 8;30(7):1388-96. doi: 10.1016/j.vaccine.2011.12.009. Epub 2011 Dec 20. |
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All subjects enrolled were included in the trial.
Subjects were enrolled from 27 centers across Finland and Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | TIV + aH5N1 (18-60 Yrs) | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
| FG001 | PL+ aTIV (18-60 Yrs) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Trivalent influenza virus vaccine (TIV) | Biological | A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm. |
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| Adjuvanted monovalent influenza virus vaccine (aH5N1) | Biological | Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle. |
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| Adjuvanted trivalent influenza virus vaccine (aTIV) | Biological | Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle. |
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| Up to 6 days after each vaccination. |
| Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the homologous A/Vietnam/1194/2004 strain, as determined by Hemagglutination Inhibition (HI) assay and Microneutralization (MN) assay. | Day 22, Day 43, Day 64 |
| Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1). | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, in terms of GMAs as determined by Single Radial Hemolysis (SRH) assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64. | Day 22, Day 43, Day 64 |
| Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen,in terms of GMRs against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays. | Day 43/Day 22, Day 64/Day 22 |
| Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm^2, as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64. | Day 22, Day 43 and Day 64 |
| Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays. | Day 43/Day 22 and Day 64/Day 22 |
| GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays. | Day 22, Day 43 and Day 64 |
| GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMAs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64. | Day 22, Day 43 and Day 64 |
| GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMRs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI, MN and SRH assays. | Day 43/Day 22 and Day 64/Day 22 |
| Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm^2 as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Vaccine on Day 22, Day 43, Day 64. | Day 22, Day 43 and Day 64 |
| Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays. | Day 43/Day 22 and Day 64/Day 22) |
| Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Days 22, Day 43 and Day 64. | Day 22, Day 43 and Day 64 |
| Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Day 22, Day 43 and Day 64. | Day 22, Day 43 and Day 64 |
| Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22. | Day 43/Day 22 and Day 64/Day 22 |
| Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against Heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22. | Day 43/Day 22 and Day 64/Day 22 |
| Number of Subjects Reporting Unsolicited AEs After Vaccination. | The number of subjects reporting any unsolicited AEs any, Possibly/probably related AEs, serious adverse events (SAEs), AEs leading to withdrawal (WD), AEs leading to death from Day 1 through Day 224 post vaccination. | Day 1 through Day 224 post vaccination |
| München |
| 80799 |
| Germany |
First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
| FG002 | TIV + aH5N1 (>60 Yrs) | First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1). |
| FG003 | PL+ aTIV (>60 Yrs) | First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV). |
| COMPLETED |
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| NOT COMPLETED |
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The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.
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| ID | Title | Description |
|---|---|---|
| BG000 | TIV + aH5N1 | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
| BG001 | PL+ aTIV | First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Subjects analyzed is not consistent with Participant module due to randomization errors. | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated. | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. | To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group. | The analysis was performed on the Safety Set population. | Posted | Number | Participants | Up to 6 days after each vaccination. |
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| Secondary | The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. | To evaluate the safety and tolerability profile of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (aTIV), in terms of the number of subjects who reported local and systemic reactions up to 6 days after each vaccination per vaccination group. | The analysis was performed on the Safety set population. | Posted | Number | Subjects | Up to 6 days after each vaccination. |
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| Secondary | Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the homologous A/Vietnam/1194/2004 strain, as determined by Hemagglutination Inhibition (HI) assay and Microneutralization (MN) assay. | The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset - All subjects in the enrolled population who were in the immunogenicity subset and who actually received at least one dose of AdjPanH5N1 or Adj Seasonal, and provided at leatr one evaluable serum sample both before and after baseline. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 22, Day 43, Day 64 |
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| Secondary | Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1). | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, in terms of GMAs as determined by Single Radial Hemolysis (SRH) assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64. | The analysis was performed on FAS population. | Posted | Geometric Mean | 95% Confidence Interval | Areas (mm^2) | Day 22, Day 43, Day 64 |
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| Secondary | Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen,in terms of GMRs against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays. | The analysis was performed on FAS population. | Posted | Geometric Mean | 95% Confidence Interval | Ratios | Day 43/Day 22, Day 64/Day 22 |
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| Secondary | Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm^2, as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22, Day 43 and Day 64 |
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| Secondary | Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 43/Day 22 and Day 64/Day 22 |
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| Secondary | GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays. | The analysis was performed on FAS population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 22, Day 43 and Day 64 |
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| Secondary | GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMAs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64. | The analysis was performed on FAS population. | Posted | Geometric Mean | 95% Confidence Interval | Areas (mm^2) | Day 22, Day 43 and Day 64 |
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| Secondary | GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMRs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI, MN and SRH assays. | The analysis was performed on FAS population. | Posted | Geometric Mean | 95% Confidence Interval | Ratios | Day 43/Day 22 and Day 64/Day 22 |
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| Secondary | Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm^2 as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Vaccine on Day 22, Day 43, Day 64. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22, Day 43 and Day 64 |
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| Secondary | Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 43/Day 22 and Day 64/Day 22) |
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| Primary | Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine. | To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of <=0.1%, & uncommon AEs in elderly, i.e. occurring at a frequency of <=1% of subjects. | The analysis was performed on the Safety set population. | Posted | Number | Participants | Upto Day 224 post vaccination |
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| Secondary | Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Days 22, Day 43 and Day 64. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22, Day 43 and Day 64 |
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| Secondary | Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Day 22, Day 43 and Day 64. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22, Day 43 and Day 64 |
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| Secondary | Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 43/Day 22 and Day 64/Day 22 |
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| Secondary | Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains. | To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against Heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22. | The analysis was performed on FAS population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 43/Day 22 and Day 64/Day 22 |
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| Secondary | Number of Subjects Reporting Unsolicited AEs After Vaccination. | The number of subjects reporting any unsolicited AEs any, Possibly/probably related AEs, serious adverse events (SAEs), AEs leading to withdrawal (WD), AEs leading to death from Day 1 through Day 224 post vaccination. | Analysis was done on safety population. | Posted | Number | Subjects | Day 1 through Day 224 post vaccination |
|
Throughout the study ie. Day 1 to Day 224
The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled 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 | TIV + aH5N1 (18-60 Yrs) | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). | 40 | 2,680 | 2,301 | 2,680 | ||
| EG001 | PL + aTIV (18-60 Yrs) | First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV). | 9 | 676 | 590 | 676 | ||
| EG002 | TIV + aH5N1 (>60 Yrs) | First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1). | 1 | 222 | 176 | 222 | ||
| EG003 | PL + aTIV (>60 Yrs) | First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV). | 2 | 56 | 45 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster opthalmic | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Gas poisoning | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Vaccination failure | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Cerebellar haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Cerebral infraction | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Schizophrenia,paranoid type | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Urethral caruncle | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchial hyperactivity | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhoid operation | 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 |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site haemorrahage | 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 |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | 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 |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
| >60 years |
|
|
|
| Male (<=60 yrs) |
|
|
| Female (>60 yrs) |
|
|
| Male (>60 yrs) |
|
|
| Injection site erythema |
|
| Injection site induration |
|
| Injection site swelling |
|
| Injection site pain |
|
| Systemic reactions |
|
| Chills |
|
| Malaise |
|
| Myalgia |
|
| Arthralgia |
|
| Nausea |
|
| Headache |
|
| Sweating |
|
| Fatigue |
|
| Fever ≥ 38°C |
|
| Stayed at home |
|
| Analgesic Antipyretic medi. used |
|
| OG003 | PL+ aTIV (>60 Yrs) | First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV). |
|
|
First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
| OG003 | TIV + aH5N1 (>60 Yrs) MN Assay | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
|
| TIV + aH5N1 (>60 Yrs) MN Assay |
First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1). |
| OG004 | TIV + aH5N1 (18-60 Yrs) SRH Assay | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
| OG005 | TIV + aH5N1 (>60 Yrs) SRH Assay | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic vaccine (aH5N1).
| OG003 | TIV + aH5N1 (>60 Yrs) SRH Areas ≥ 25mm^2 | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
| OG003 | TIV + aH5N1 (>60 Yrs) SRH Areas | First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
| TIV + aH5N1 (>60 Yrs) MN Assay |
First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
|
|
| TIV + aH5N1 (>60 Yrs) MN Assay |
First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1). |
| OG004 | TIV + aH5N1 (18-60 Yrs) SRH Assay | First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1). |
| OG005 | TIV + aH5N1 (>60 Yrs) SRH Assay | First dose of the non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
| OG003 | TIV + aH5N1 (>60 Yrs) SRH Areas≥ 25mm^2 | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
| OG003 | TIV + aH5N1 (>60 Yrs) SRH Areas | First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1). |
|
|
First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV). |
|
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|
|
|
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