Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00481065
Collaborator
Novartis Vaccines (Industry)
405
1
8
20
20.2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
405 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects
Study Start Date
:
Apr 1, 2007
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 mixed extemporaneously with eTIV_a on day 382. |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
| Experimental: 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 |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
| Experimental: 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 |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
| Experimental: 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 |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
| Experimental: Mixed and mixed 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
| Experimental: 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 |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
| Experimental: 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 |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
| Experimental: 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 |
Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a
|
Outcome Measures
Primary Outcome Measures
- Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine [21 days after second and third vaccinations (day 43 and day 403)]
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.
- Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine [21 days after second and third vaccinations (day 22 and day 43)]
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.
- Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) [21 days after second vaccination (day 43)]
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.
- Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) [21 days after second and third vaccinations (day 43 and day 403)]
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.
- Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) [21 days after second and third vaccinations (day 43 and day 403)]
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.
- Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) [21 days after second vaccination (day 43)]
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.
- Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) [21 days after second and third vaccinations (day 43 and day 403)]
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.
- Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) [21 days after second and third vaccinations (day 43 and day 403)]
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.
Secondary Outcome Measures
- Number of Subjects Reporting Local and Systemic Reactions by Vaccination [21 days after second and third vaccinations (day 43 and day 403)]
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.
- 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 [21 days after booster vaccination (day 403)]
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.
- Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [21 days after booster vaccination (day 403)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy subjects
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bogotà | Colombia |
Sponsors and Collaborators
- Novartis
- Novartis Vaccines
Investigators
- Study Chair: Novartis Drug Information Services +1 800 244 7668, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00481065
Other Study ID Numbers:
- V87P5
First Posted:
Jun 1, 2007
Last Update Posted:
Feb 3, 2014
Last Verified:
Dec 1, 2013
Keywords provided by Novartis
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at 1 center in Colombia. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Period Title: Overall Study | ||||||||
| STARTED | 51 | 50 | 51 | 52 | 51 | 51 | 50 | 49 |
| COMPLETED | 29 | 33 | 32 | 37 | 28 | 27 | 34 | 30 |
| NOT COMPLETED | 22 | 17 | 19 | 15 | 23 | 24 | 16 | 19 |
Baseline Characteristics
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 | Total of all reporting groups |
| Overall Participants | 51 | 50 | 51 | 52 | 51 | 51 | 50 | 49 | 405 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
29
(6.2)
|
29.4
(5.8)
|
29.5
(6.5)
|
29.8
(6.8)
|
29.6
(6.1)
|
28.8
(6.2)
|
27.9
(6.2)
|
30.1
(6.2)
|
29.3
(6.2)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
42
82.4%
|
31
62%
|
36
70.6%
|
30
57.7%
|
36
70.6%
|
39
76.5%
|
30
60%
|
32
65.3%
|
276
68.1%
|
| Male |
9
17.6%
|
19
38%
|
15
29.4%
|
22
42.3%
|
15
29.4%
|
12
23.5%
|
20
40%
|
17
34.7%
|
129
31.9%
|
Outcome Measures
| Title | Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second and third vaccinations (day 43 and day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the full analysis set (FAS). |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 47 | 50 | 49 | 48 | 48 | 44 |
| HI seroprot. (day1) N=46,48,47,50,49,48,48,44 |
0
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
| HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43 |
12
|
33
|
37
|
13
|
31
|
34
|
19
|
22
|
| HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43 |
12
|
34
|
37
|
14
|
32
|
34
|
19
|
22
|
| HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32 |
17
|
15
|
26
|
19
|
16
|
13
|
24
|
16
|
| HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25 |
18
|
15
|
26
|
20
|
16
|
14
|
24
|
16
|
| SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44) |
3
|
6
|
1
|
4
|
4
|
6
|
4
|
5
|
| SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42 |
14
|
38
|
43
|
11
|
31
|
38
|
23
|
25
|
| SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43 |
17
|
40
|
43
|
14
|
35
|
42
|
26
|
29
|
| SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25 |
24
|
20
|
27
|
27
|
12
|
12
|
18
|
16
|
| SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25 |
25
|
21
|
27
|
27
|
11
|
15
|
23
|
19
|
| MN ≥40 (day 1) N=46,48,47,50,49,48,48,44) |
11
|
11
|
10
|
11
|
10
|
10
|
11
|
11
|
| MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43 |
14
|
36
|
44
|
16
|
36
|
44
|
24
|
20
|
| MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25 |
24
|
24
|
28
|
31
|
22
|
20
|
26
|
23
|
| Title | Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second and third vaccinations (day 22 and day 43) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 47 | 50 | 49 | 48 | 48 | 44 |
| HI (2nd vacc) N= 46,48,46,49,48,48,47,43 |
2.11
|
12
|
23
|
2.16
|
9.52
|
14
|
2.96
|
5.34
|
| HI (3rd vacc) N= 24,25,28,35,25,20,28,25 |
34
|
17
|
93
|
10
|
9.89
|
21
|
66
|
12
|
| SRH (2nd vacc) N= 46,48,46,49,46,47,47,42 |
1.82
|
5.32
|
9.64
|
1.58
|
4.25
|
6.04
|
2.9
|
3.26
|
| SRH (3rd vacc) N= 25,25,28,35,25,20,28,25 |
9.92
|
6.22
|
11
|
5.13
|
3.1
|
6.76
|
7.17
|
4.55
|
| MN (2nd vacc) N= 46,48,47,50,49,48,48,44 |
2.12
|
7.64
|
13
|
2.15
|
6.79
|
11
|
3.86
|
3.49
|
| MN (3rd vacc) N= 24,25,28,35,25,20,28,25 |
38
|
39
|
66
|
16
|
13
|
23
|
58
|
21
|
| Title | Number of Subjects Reporting Local and Systemic Reactions by Vaccination |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second and third vaccinations (day 43 and day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 50 | 50 | 51 | 51 | 51 | 50 | 49 | 49 |
| Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc |
0
|
8
|
8
|
0
|
8
|
8
|
7
|
5
|
| Induration (N=50,48,47,51,48,47,47,43) 2nd vacc |
0
|
2
|
3
|
0
|
3
|
2
|
1
|
3
|
| Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc |
0
|
2
|
5
|
0
|
4
|
1
|
1
|
1
|
| Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc |
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
| Pain (N=50,48,47,51,48,47,47,43) 2nd vacc |
0
|
21
|
16
|
0
|
20
|
18
|
12
|
16
|
| Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc |
8
|
4
|
9
|
9
|
0
|
7
|
6
|
11
|
| Induration (N=31,33,36,39,31,29,34,31) 3rd vacc |
6
|
6
|
14
|
9
|
0
|
9
|
7
|
8
|
| Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc |
5
|
3
|
9
|
2
|
0
|
8
|
6
|
5
|
| Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc |
2
|
1
|
1
|
1
|
1
|
1
|
2
|
3
|
| Pain (N=31,33,36,39,31,29,34,31) 3rd vacc |
20
|
16
|
21
|
23
|
20
|
0
|
17
|
15
|
| Chills (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
0
|
1
|
NA
|
2
|
4
|
2
|
2
|
| Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
2
|
4
|
NA
|
7
|
6
|
2
|
6
|
| Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
8
|
7
|
NA
|
9
|
6
|
3
|
5
|
| Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
0
|
3
|
NA
|
1
|
4
|
2
|
2
|
| Headache (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
2
|
5
|
NA
|
6
|
5
|
3
|
4
|
| Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
0
|
1
|
NA
|
0
|
2
|
1
|
1
|
| Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
1
|
0
|
NA
|
1
|
1
|
2
|
2
|
| Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
0
|
1
|
NA
|
1
|
1
|
2
|
2
|
| Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc |
NA
|
0
|
0
|
NA
|
1
|
3
|
0
|
2
|
| Chills (N=31,49,36,39,31,50,34,49) 3rd vacc |
3
|
0
|
6
|
3
|
4
|
0
|
3
|
0
|
| Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc |
6
|
5
|
9
|
10
|
8
|
7
|
9
|
7
|
| Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc |
12
|
11
|
17
|
13
|
12
|
10
|
8
|
13
|
| Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc |
2
|
0
|
5
|
4
|
4
|
3
|
4
|
4
|
| Headache (N=31,32,36,39,31,29,34,32) 3rd vacc |
8
|
7
|
11
|
7
|
10
|
8
|
5
|
7
|
| Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc |
2
|
0
|
2
|
2
|
0
|
1
|
0
|
3
|
| Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc |
2
|
1
|
3
|
1
|
2
|
2
|
1
|
1
|
| Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc |
1
|
1
|
3
|
2
|
3
|
0
|
2
|
2
|
| Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc |
2
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
| Title | Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second vaccination (day 43) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the full analysis set (FAS). |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 47 | 50 | 49 | 48 | 48 | 44 |
| HI seroprot. (day 1) |
13
|
18
|
16
|
23
|
15
|
19
|
24
|
20
|
| HI seroconversion N=46,48,46,49,48,48,47,43 |
33
|
35
|
36
|
29
|
37
|
37
|
29
|
31
|
| HI seroprotection N=46,48,46,49,48,48,47,43 |
37
|
45
|
43
|
39
|
44
|
41
|
43
|
40
|
| Title | Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second and third vaccinations (day 43 and day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the full analysis set (FAS). |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 47 | 50 | 49 | 48 | 48 | 44 |
| HI seroprot. (day 1) |
20
|
22
|
14
|
23
|
26
|
22
|
12
|
22
|
| HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43 |
23
|
36
|
35
|
35
|
40
|
40
|
35
|
29
|
| HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43) |
39
|
46
|
44
|
49
|
48
|
48
|
47
|
40
|
| HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25 |
19
|
20
|
26
|
30
|
18
|
17
|
25
|
21
|
| HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32 |
18
|
15
|
26
|
20
|
16
|
14
|
86
|
64
|
| Title | Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second and third vaccinations (day 43 and day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the full analysis set (FAS). |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 47 | 50 | 49 | 48 | 48 | 44 |
| HI seroprot. (day 1) |
5
|
4
|
6
|
10
|
2
|
9
|
12
|
5
|
| HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43 |
37
|
38
|
36
|
41
|
41
|
35
|
36
|
28
|
| HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43 |
40
|
43
|
42
|
46
|
44
|
45
|
44
|
32
|
| HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25 |
19
|
17
|
19
|
27
|
15
|
13
|
11
|
15
|
| HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25 |
22
|
21
|
22
|
31
|
18
|
18
|
17
|
20
|
| Title | Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second vaccination (day 43) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 46 | 50 | 48 | 48 | 47 | 43 |
| Geometric Mean (95% Confidence Interval) [Ratio] |
15
|
13
|
14
|
6.77
|
12
|
10
|
6.23
|
11
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | 21 days after booster vaccination (day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) |
| Arm/Group Title | Mixed | Mixed + Mixed |
|---|---|---|
| Arm/Group Description | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 |
| Measure Participants | 39 | 31 |
| Seroprotection (HI) _MF59-H5N1 (N=35, 25) |
26
|
16
|
| Seroconversion (HI)_MF59-H5N1 |
25
|
15
|
| Seroprotection (SRH)_MF59-H5N1 (N=35, 25) |
50
|
7
|
| Seroconversion (SRH)_MF59-H5N1 (N=35, 25) |
21
|
10
|
| Seroprotection (HI) - eTIV_a (H1N1) N=35, 25 |
33
|
24
|
| Seroconversion (HI) - eTIV_a (H1N1) N=39, 25 |
17
|
10
|
| Seroprotection (HI) - eTIV_a (H3N2) N=35, 25 |
35
|
25
|
| Seroconversion (HI) - eTIV_a (H3N2) N=39, 25 |
12
|
5
|
| Seroprotection (HI) - eTIV_a (B) N=35, 25 |
31
|
18
|
| Seroconversion (HI) - seTIV_a (B) N=35, 25 |
6
|
4
|
| Title | Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second and third vaccinations (day 43 and day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 47 | 50 | 49 | 48 | 48 | 44 |
| HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43 |
6.01
|
9.72
|
9.34
|
11
|
11
|
10
|
11
|
7.54
|
| HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25 |
17
|
10
|
17
|
18
|
8.92
|
11
|
17
|
13
|
| Title | Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) |
|---|---|
| Description | 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. |
| Time Frame | 21 days after second and third vaccinations (day 43 and day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) |
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 |
| Measure Participants | 46 | 48 | 47 | 50 | 49 | 48 | 48 | 44 |
| HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43 |
11
|
13
|
10
|
10
|
17
|
8.77
|
10
|
8.0
|
| HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25 |
8.85
|
5.47
|
7.95
|
7.17
|
5.29
|
5.1
|
4.17
|
4.26
|
| Title | Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine |
|---|---|
| Description | 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. |
| Time Frame | 21 days after booster vaccination (day 403) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) |
| Arm/Group Title | Mixed | Mixed + Mixed |
|---|---|---|
| Arm/Group Description | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 |
| Measure Participants | 39 | 31 |
| HI (MF59-H5N1) N=35, 25 |
13
|
7.14
|
| SRH (MF59-H5N1) N=35, 25 |
4.88
|
2.77
|
| HI (eTIV_a, H1N1) N=35, 25 |
4.82
|
2.61
|
| HI (eTIV_a, H3N2) N=35, 25 |
2.62
|
2.21
|
| HI (eTIV_a, B) N=35, 25 |
1.96
|
1.94
|
Adverse Events
| Time Frame | All adverse events and serious adverse events were collected for 20 months (the duration of the study). | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||||||||||||
| Arm/Group Title | Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 | ||||||||
| Arm/Group Description | 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 | 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 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 | 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 | dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 | 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 | 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 | 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 | ||||||||
All Cause Mortality |
||||||||||||||||
| Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/50 (8%) | 1/50 (2%) | 2/51 (3.9%) | 3/51 (5.9%) | 3/51 (5.9%) | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Appendicitis | 0/50 (0%) | 1/50 (2%) | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Gastrointestinal infection | 0/50 (0%) | 0/50 (0%) | 0/51 (0%) | 1/51 (2%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Periorbital cellulitis | 1/50 (2%) | 0/50 (0%) | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Pneumonia | 0/50 (0%) | 0/50 (0%) | 0/51 (0%) | 1/51 (2%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Head injury | 0/50 (0%) | 0/50 (0%) | 0/51 (0%) | 1/51 (2%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Joint dislocation | 0/50 (0%) | 0/50 (0%) | 0/51 (0%) | 0/51 (0%) | 1/51 (2%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Injury | 1/50 (2%) | 0/50 (0%) | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Investigations | ||||||||||||||||
| Aspiration bronchial | 0/50 (0%) | 0/50 (0%) | 0/51 (0%) | 0/51 (0%) | 1/51 (2%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| B-Cell small lymphocytic lymphoma | 0/50 (0%) | 0/50 (0%) | 1/51 (2%) | 0/51 (0%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Ependymoma | 0/50 (0%) | 0/50 (0%) | 1/51 (2%) | 0/51 (0%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||
| Abortion spontaneous | 1/50 (2%) | 0/50 (0%) | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | ||||||||
| Abortion spontaneous incomplete | 1/50 (2%) | 0/50 (0%) | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| Vaginal haemorrhage | 0/50 (0%) | 0/50 (0%) | 0/51 (0%) | 0/51 (0%) | 1/51 (2%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Concomitant Alone | Concomitant+Mixed | Concomitant+MF59-eH5N1 | Mixed | Mixed + Mixed | Mixed+MF59-eH5N1 | MF59-eH5N1+eTIV_a | eTIV_a+MF59-eH5N1 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/50 (76%) | 42/50 (84%) | 41/51 (80.4%) | 39/51 (76.5%) | 42/51 (82.4%) | 43/50 (86%) | 37/49 (75.5%) | 38/49 (77.6%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Gastritis | 1/50 (2%) | 3/50 (6%) | 0/51 (0%) | 2/51 (3.9%) | 2/51 (3.9%) | 1/50 (2%) | 4/49 (8.2%) | 1/49 (2%) | ||||||||
| Nausea | 4/50 (8%) | 5/50 (10%) | 6/51 (11.8%) | 2/51 (3.9%) | 5/51 (9.8%) | 4/50 (8%) | 4/49 (8.2%) | 7/49 (14.3%) | ||||||||
| General disorders | ||||||||||||||||
| Chills | 5/50 (10%) | 5/50 (10%) | 10/51 (19.6%) | 8/51 (15.7%) | 8/51 (15.7%) | 8/50 (16%) | 5/49 (10.2%) | 3/49 (6.1%) | ||||||||
| Fatigue | 3/50 (6%) | 4/50 (8%) | 5/51 (9.8%) | 3/51 (5.9%) | 5/51 (9.8%) | 4/50 (8%) | 4/49 (8.2%) | 4/49 (8.2%) | ||||||||
| Injection site erythema | 12/50 (24%) | 17/50 (34%) | 17/51 (33.3%) | 16/51 (31.4%) | 21/51 (41.2%) | 16/50 (32%) | 16/49 (32.7%) | 21/49 (42.9%) | ||||||||
| Injection site haemorrhage | 3/50 (6%) | 5/50 (10%) | 2/51 (3.9%) | 5/51 (9.8%) | 5/51 (9.8%) | 3/50 (6%) | 3/49 (6.1%) | 3/49 (6.1%) | ||||||||
| Injection site induration | 11/50 (22%) | 15/50 (30%) | 20/51 (39.2%) | 16/51 (31.4%) | 15/51 (29.4%) | 15/50 (30%) | 10/49 (20.4%) | 15/49 (30.6%) | ||||||||
| Injection site pain | 29/50 (58%) | 34/50 (68%) | 33/51 (64.7%) | 32/51 (62.7%) | 34/51 (66.7%) | 32/50 (64%) | 33/49 (67.3%) | 29/49 (59.2%) | ||||||||
| Injection site swelling | 8/50 (16%) | 9/50 (18%) | 13/51 (25.5%) | 10/51 (19.6%) | 10/51 (19.6%) | 10/50 (20%) | 9/49 (18.4%) | 11/49 (22.4%) | ||||||||
| Malaise | 15/50 (30%) | 17/50 (34%) | 21/51 (41.2%) | 19/51 (37.3%) | 20/51 (39.2%) | 21/50 (42%) | 17/49 (34.7%) | 13/49 (26.5%) | ||||||||
| Pyrexia | 5/50 (10%) | 0/50 (0%) | 1/51 (2%) | 4/51 (7.8%) | 4/51 (7.8%) | 8/50 (16%) | 2/49 (4.1%) | 6/49 (12.2%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Influenza | 3/50 (6%) | 1/50 (2%) | 0/51 (0%) | 1/51 (2%) | 1/51 (2%) | 1/50 (2%) | 1/49 (2%) | 1/49 (2%) | ||||||||
| Sinusitis | 1/50 (2%) | 1/50 (2%) | 0/51 (0%) | 0/51 (0%) | 1/51 (2%) | 0/50 (0%) | 0/49 (0%) | 3/49 (6.1%) | ||||||||
| Tonsillitis | 2/50 (4%) | 2/50 (4%) | 0/51 (0%) | 0/51 (0%) | 2/51 (3.9%) | 3/50 (6%) | 1/49 (2%) | 0/49 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Arthralgia | 3/50 (6%) | 4/50 (8%) | 9/51 (17.6%) | 6/51 (11.8%) | 6/51 (11.8%) | 9/50 (18%) | 7/49 (14.3%) | 6/49 (12.2%) | ||||||||
| Myalgia | 15/50 (30%) | 24/50 (48%) | 24/51 (47.1%) | 23/51 (45.1%) | 22/51 (43.1%) | 17/50 (34%) | 18/49 (36.7%) | 17/49 (34.7%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Headache | 18/50 (36%) | 15/50 (30%) | 22/51 (43.1%) | 14/51 (27.5%) | 25/51 (49%) | 19/50 (38%) | 13/49 (26.5%) | 15/49 (30.6%) | ||||||||
| Migraine | 3/50 (6%) | 1/50 (2%) | 0/51 (0%) | 1/51 (2%) | 0/51 (0%) | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Cough | 0/50 (0%) | 0/50 (0%) | 1/51 (2%) | 2/51 (3.9%) | 2/51 (3.9%) | 4/50 (8%) | 1/49 (2%) | 0/49 (0%) | ||||||||
| Oropharyngeal pain | 0/50 (0%) | 0/50 (0%) | 1/51 (2%) | 3/51 (5.9%) | 2/51 (3.9%) | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Hyperhidrosis | 3/50 (6%) | 2/50 (4%) | 8/51 (15.7%) | 4/51 (7.8%) | 3/51 (5.9%) | 4/50 (8%) | 2/49 (4.1%) | 4/49 (8.2%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00481065
Other Study ID Numbers:
- V87P5
First Posted:
Jun 1, 2007
Last Update Posted:
Feb 3, 2014
Last Verified:
Dec 1, 2013