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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant alone | Experimental | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382. |
|
| Concomitant +Mixed | Experimental | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
|
| Concomitant +MF59-eH5N1 | Experimental | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
|
| Mixed | Experimental | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
|
| Mixed and mixed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF59-eH5N1 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine | Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | 21 days after second and third vaccinations (day 43 and day 403) |
| Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine | Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1. | 21 days after second and third vaccinations (day 22 and day 43) |
| Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) | seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | 21 days after second vaccination (day 43) |
| Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) | seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | 21 days after second and third vaccinations (day 43 and day 403) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Local and Systemic Reactions by Vaccination | The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine. | 21 days after second and third vaccinations (day 43 and day 403) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Drug Information Services +1 800 244 7668 | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bogotá | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21606530 | Result | Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191. | |
| 23536690 |
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All subjects enrolled were included in the trial. A total of 405 subjects was enrolled and randomized into 8 groups in this study. The participant flow data are from the all randomized set.
Participants were enrolled at 1 center in Colombia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Concomitant Alone | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| FG001 | Concomitant+Mixed | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| FG002 | Concomitant+MF59-eH5N1 | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| FG003 | Mixed | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| FG004 | Mixed + Mixed | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 |
| FG005 | Mixed+MF59-eH5N1 | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| FG006 | MF59-eH5N1+eTIV_a | 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| FG007 | eTIV_a+MF59-eH5N1 | 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The demographic characteristics of the randomized population are summarized in this section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Concomitant Alone | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| BG001 | Concomitant+Mixed |
| 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 Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine | Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | The analysis was done on the full analysis set (FAS). | Posted | Number | Subjects | 21 days after second and third vaccinations (day 43 and day 403) |
|
All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
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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 | Concomitant Alone | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
Not provided
| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
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| Experimental |
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 |
|
| Mixed+MF59-eH5N1 | Experimental | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
|
| MF59-eH5N1+eTIV_a | Experimental | 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
|
| eTIV_a+MF59-eH5N1 | Experimental | 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
|
| eTIV_a | Biological |
|
| MF59-eH5N1 + eTIV_a | Biological |
|
| Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) | seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | 21 days after second and third vaccinations (day 43 and day 403) |
| Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) | For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1. | 21 days after second vaccination (day 43) |
| Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) | For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1. | 21 days after second and third vaccinations (day 43 and day 403) |
| Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) | For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1. | 21 days after second and third vaccinations (day 43 and day 403) |
| Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine | Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382. | 21 days after booster vaccination (day 403) |
| Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine | For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose. | 21 days after booster vaccination (day 403) |
| Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Inappropriate enrollment |
|
| Administrative reason |
|
| Protocol Violation |
|
| Unable to classify |
|
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| BG002 | Concomitant+MF59-eH5N1 | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| BG003 | Mixed | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| BG004 | Mixed + Mixed | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 |
| BG005 | Mixed+MF59-eH5N1 | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| BG006 | MF59-eH5N1+eTIV_a | 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| BG007 | eTIV_a+MF59-eH5N1 | 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Concomitant+Mixed | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| OG002 | Concomitant+MF59-eH5N1 | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| OG003 | Mixed | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| OG004 | Mixed + Mixed | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 |
| OG005 | Mixed+MF59-eH5N1 | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| OG006 | MF59-eH5N1+eTIV_a | 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
| OG007 | eTIV_a+MF59-eH5N1 | 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 |
|
|
| Primary | Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine | Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1. | Full analysis set (FAS) | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 21 days after second and third vaccinations (day 22 and day 43) |
|
|
|
| Secondary | Number of Subjects Reporting Local and Systemic Reactions by Vaccination | The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine. | Posted | Number | Subjects | 21 days after second and third vaccinations (day 43 and day 403) |
|
|
|
| Primary | Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) | seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | The analysis was done on the full analysis set (FAS). | Posted | Number | Subjects | 21 days after second vaccination (day 43) |
|
|
|
| Primary | Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) | seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | The analysis was done on the full analysis set (FAS). | Posted | Number | Subjects | 21 days after second and third vaccinations (day 43 and day 403) |
|
|
|
| Primary | Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) | seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. | The analysis was done on the full analysis set (FAS). | Posted | Number | Subjects | 21 days after second and third vaccinations (day 43 and day 403) |
|
|
|
| Primary | Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) | For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1. | Full analysis set (FAS) | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 21 days after second vaccination (day 43) |
|
|
|
| Secondary | Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine | Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382. | Full analysis set (FAS) | Posted | Number | Subjects | 21 days after booster vaccination (day 403) |
|
|
|
| Primary | Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) | For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1. | Full analysis set (FAS) | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 21 days after second and third vaccinations (day 43 and day 403) |
|
|
|
| Primary | Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) | For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1. | Full analysis set (FAS) | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 21 days after second and third vaccinations (day 43 and day 403) |
|
|
|
| Secondary | Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine | For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose. | Full analysis set (FAS) | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 21 days after booster vaccination (day 403) |
|
|
|
| 4 |
| 50 |
| 38 |
| 50 |
| EG001 | Concomitant+Mixed | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 | 1 | 50 | 42 | 50 |
| EG002 | Concomitant+MF59-eH5N1 | 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 | 2 | 51 | 41 | 51 |
| EG003 | Mixed | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 | 3 | 51 | 39 | 51 |
| EG004 | Mixed + Mixed | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 3 | 51 | 42 | 51 |
| EG005 | Mixed+MF59-eH5N1 | 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 | 0 | 50 | 43 | 50 |
| EG006 | MF59-eH5N1+eTIV_a | 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 | 0 | 49 | 37 | 49 |
| EG007 | eTIV_a+MF59-eH5N1 | 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 | 1 | 49 | 38 | 49 |
| Gastrointestinal infection | Infections and infestations | Non-systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Aspiration bronchial | Investigations | Non-systematic Assessment |
|
| B-Cell small lymphocytic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Ependymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | Non-systematic Assessment |
|
| Injection site induration | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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Not provided
| D001715 |
| Bird Diseases |
| D000820 | Animal Diseases |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| HI (3rd vacc) N= 24,25,28,35,25,20,28,25 |
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| SRH (2nd vacc) N= 46,48,46,49,46,47,47,42 |
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| SRH (3rd vacc) N= 25,25,28,35,25,20,28,25 |
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| MN (2nd vacc) N= 46,48,47,50,49,48,48,44 |
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| MN (3rd vacc) N= 24,25,28,35,25,20,28,25 |
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| Induration (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Pain (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc |
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| Induration (N=31,33,36,39,31,29,34,31) 3rd vacc |
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| Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc |
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| Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc |
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| Pain (N=31,33,36,39,31,29,34,31) 3rd vacc |
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| Chills (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Headache (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc |
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| Chills (N=31,49,36,39,31,50,34,49) 3rd vacc |
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| Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc |
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| Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc |
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| Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc |
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| Headache (N=31,32,36,39,31,29,34,32) 3rd vacc |
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| Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc |
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| Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc |
|
| Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc |
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| Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc |
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| HI seroconversion N=46,48,46,49,48,48,47,43 |
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| HI seroprotection N=46,48,46,49,48,48,47,43 |
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| HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43 |
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| HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43) |
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| HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25 |
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| HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32 |
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| HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43 |
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| HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43 |
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| HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25 |
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| HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25 |
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| Seroprotection (SRH)_MF59-H5N1 (N=35, 25) |
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| Seroconversion (SRH)_MF59-H5N1 (N=35, 25) |
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| Seroprotection (HI) - eTIV_a (H1N1) N=35, 25 |
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| Seroconversion (HI) - eTIV_a (H1N1) N=39, 25 |
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| Seroprotection (HI) - eTIV_a (H3N2) N=35, 25 |
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| Seroconversion (HI) - eTIV_a (H3N2) N=39, 25 |
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| Seroprotection (HI) - eTIV_a (B) N=35, 25 |
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| Seroconversion (HI) - seTIV_a (B) N=35, 25 |
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| HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25 |
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| HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25 |
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| HI (eTIV_a, H1N1) N=35, 25 |
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| HI (eTIV_a, H3N2) N=35, 25 |
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| HI (eTIV_a, B) N=35, 25 |
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