Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00481065

Enrollment

405

Registered

2007-06-01

Start date

2007-04-30

Completion date

2008-12-31

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avian Influenza, Pandemic

Keywords

Bird flu, influenza vaccine, Seasonal influenza vaccine, Prepandemic vaccine

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.

Interventions

BIOLOGICALMF59-eH5N1

BIOLOGICALeTIV_a

BIOLOGICALMF59-eH5N1 + eTIV_a

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

Colombia

Participant flow

Recruitment details

Participants were enrolled at 1 center in Colombia.

Pre-assignment details

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 by arm

Arm	Count
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	51
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	50
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	51
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	52
Mixed + Mixed dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382	51
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	51
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	50
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	49
Total	405

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007
Overall Study	Administrative reason	0	0	0	0	0	2	1	0
Overall Study	Adverse event or death	1	1	3	0	2	0	1	1
Overall Study	Inappropriate enrollment	4	0	2	0	2	1	0	1
Overall Study	Lost to Follow-up	4	2	4	3	3	3	2	5
Overall Study	Protocol Violation	2	1	1	1	2	6	3	2
Overall Study	Unable to classify	0	1	2	0	1	0	0	0
Overall Study	Withdrawal by Subject	11	12	7	11	13	12	9	10

Baseline characteristics

Characteristic	Total	Concomitant Alone	Concomitant+Mixed	Concomitant+MF59-eH5N1	Mixed	Mixed + Mixed	Mixed+MF59-eH5N1	MF59-eH5N1+eTIV_a	eTIV_a+MF59-eH5N1
Age, Continuous	29.3 years STANDARD_DEVIATION 6.2	29 years STANDARD_DEVIATION 6.2	29.4 years STANDARD_DEVIATION 5.8	29.5 years STANDARD_DEVIATION 6.5	29.8 years STANDARD_DEVIATION 6.8	29.6 years STANDARD_DEVIATION 6.1	28.8 years STANDARD_DEVIATION 6.2	27.9 years STANDARD_DEVIATION 6.2	30.1 years STANDARD_DEVIATION 6.2
Sex: Female, Male Female	276 Participants	42 Participants	31 Participants	36 Participants	30 Participants	36 Participants	39 Participants	30 Participants	32 Participants
Sex: Female, Male Male	129 Participants	9 Participants	19 Participants	15 Participants	22 Participants	15 Participants	12 Participants	20 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	38 / 50	42 / 50	41 / 51	39 / 51	42 / 51	43 / 50	37 / 49	38 / 49
serious Total, serious adverse events	4 / 50	1 / 50	2 / 51	3 / 51	3 / 51	0 / 50	0 / 49	1 / 49

Outcome results

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.

Time frame: 21 days after second vaccination (day 43)

Population: Full analysis set (FAS)

Arm	Measure	Value (GEOMETRIC_MEAN)
Concomitant Alone	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	15 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	13 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	14 Ratio
Mixed	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	6.77 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	12 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	10 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	6.23 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)	11 Ratio

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.

Time frame: 21 days after second and third vaccinations (day 22 and day 43)

Population: Full analysis set (FAS)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	38 Ratio
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	2.11 Ratio
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	34 Ratio
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	1.82 Ratio
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	2.12 Ratio
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	9.92 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	5.32 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	12 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	6.22 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	39 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	17 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	7.64 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	13 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	9.64 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	93 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	11 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	66 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	23 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	2.15 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	2.16 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	10 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	1.58 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	5.13 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	16 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	6.79 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	9.89 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	13 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	9.52 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	3.1 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	4.25 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	6.04 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	6.76 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	21 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	11 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	14 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	23 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	7.17 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	3.86 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	2.96 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	2.9 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	58 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	66 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	4.55 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	3.26 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (3rd vacc) N= 24,25,28,35,25,20,28,25	21 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	MN (2nd vacc) N= 46,48,47,50,49,48,48,44	3.49 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (2nd vacc) N= 46,48,46,49,48,48,47,43	5.34 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine	HI (3rd vacc) N= 24,25,28,35,25,20,28,25	12 Ratio

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.

Time frame: 21 days after second and third vaccinations (day 43 and day 403)

Population: Full analysis set (FAS)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	11 Ratio
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	8.85 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	13 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	5.47 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	10 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	7.95 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	10 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	7.17 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	17 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	5.29 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	8.77 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	5.1 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	4.17 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	10 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	8.0 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	4.26 Ratio

Primary

Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)

Time frame: 21 days after second and third vaccinations (day 43 and day 403)

Population: Full analysis set (FAS)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	6.01 Ratio
Concomitant Alone	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	17 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	9.72 Ratio
Concomitant+Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	10 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	9.34 Ratio
Concomitant+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	17 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	11 Ratio
Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	18 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	11 Ratio
Mixed + Mixed	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	8.92 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	10 Ratio
Mixed+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	11 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	17 Ratio
MF59-eH5N1+eTIV_a	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	11 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43	7.54 Ratio
eTIV_a+MF59-eH5N1	Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)	HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25	13 Ratio

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.

Time frame: 21 days after second and third vaccinations (day 43 and day 403)

Population: The analysis was done on the full analysis set (FAS).

Arm	Measure	Group	Value (NUMBER)
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	37 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	19 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	22 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	5 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	40 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	21 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	38 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	17 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	4 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	43 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	42 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	6 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	22 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	36 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	19 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	27 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	46 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	31 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	10 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	41 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	18 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	2 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	41 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	44 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	15 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	45 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	9 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	18 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	13 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	35 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	12 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	11 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	36 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	17 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	44 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	32 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43	28 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	20 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	15 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)	HI seroprot. (day 1)	5 Subjects

Primary

Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)

Time frame: 21 days after second and third vaccinations (day 43 and day 403)

Population: The analysis was done on the full analysis set (FAS).

Arm	Measure	Group	Value (NUMBER)
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	20 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	18 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	19 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	39 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	23 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	36 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	20 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	15 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	46 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	22 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	35 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	26 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	14 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	26 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	44 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	49 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	20 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	23 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	35 Subjects
Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	30 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	48 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	26 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	40 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	18 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	16 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	48 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	17 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	40 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	22 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	14 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	47 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	12 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	35 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	86 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	25 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	64 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	21 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (day 1)	22 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	40 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	29 Subjects

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.

Time frame: 21 days after second vaccination (day 43)

Population: The analysis was done on the full analysis set (FAS).

Arm	Measure	Group	Value (NUMBER)
Concomitant Alone	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	13 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	37 Subjects
Concomitant Alone	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	33 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	45 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	35 Subjects
Concomitant+Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	18 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	43 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	16 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	36 Subjects
Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	23 Subjects
Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	29 Subjects
Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	39 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	37 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	15 Subjects
Mixed + Mixed	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	44 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	37 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	19 Subjects
Mixed+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	41 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	29 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	24 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	43 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprot. (day 1)	20 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroconversion N=46,48,46,49,48,48,47,43	31 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)	HI seroprotection N=46,48,46,49,48,48,47,43	40 Subjects

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.

Time frame: 21 days after second and third vaccinations (day 43 and day 403)

Population: The analysis was done on the full analysis set (FAS).

Arm	Measure	Group	Value (NUMBER)
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	0 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	11 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	18 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	12 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	24 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	14 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	24 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	25 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	17 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	12 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	3 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	14 Subjects
Concomitant Alone	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	17 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	6 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	15 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	1 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	20 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	11 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	21 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	36 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	24 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	15 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	33 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	34 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	40 Subjects
Concomitant+Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	38 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	26 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	43 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	37 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	0 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	44 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	37 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	10 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	26 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	27 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	1 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	28 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	27 Subjects
Concomitant+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	43 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	11 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	2 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	14 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	13 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	4 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	14 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	16 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	19 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	27 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	20 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	31 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	27 Subjects
Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	11 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	31 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	1 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	31 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	32 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	16 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	16 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	4 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	35 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	12 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	11 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	10 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	36 Subjects
Mixed + Mixed	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	22 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	38 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	0 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	12 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	6 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	14 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	15 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	13 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	20 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	10 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	34 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	44 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	34 Subjects
Mixed+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	42 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	23 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	24 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	0 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	11 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	19 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	23 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	19 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	4 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	26 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	26 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	18 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	24 Subjects
MF59-eH5N1+eTIV_a	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	24 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	16 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25	19 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	16 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	5 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (day1) N=46,48,47,50,49,48,48,44	0 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	22 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	25 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25	23 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	16 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)	11 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	29 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43	20 Subjects
eTIV_a+MF59-eH5N1	Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine	HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	22 Subjects

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.

Time frame: 21 days after booster vaccination (day 403)

Population: Full analysis set (FAS)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Concomitant Alone	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	SRH (MF59-H5N1) N=35, 25	4.88 Ratio
Concomitant Alone	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (eTIV_a, H3N2) N=35, 25	2.62 Ratio
Concomitant Alone	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (eTIV_a, H1N1) N=35, 25	4.82 Ratio
Concomitant Alone	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (eTIV_a, B) N=35, 25	1.96 Ratio
Concomitant Alone	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (MF59-H5N1) N=35, 25	13 Ratio
Concomitant+Mixed	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (eTIV_a, B) N=35, 25	1.94 Ratio
Concomitant+Mixed	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (MF59-H5N1) N=35, 25	7.14 Ratio
Concomitant+Mixed	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	SRH (MF59-H5N1) N=35, 25	2.77 Ratio
Concomitant+Mixed	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (eTIV_a, H1N1) N=35, 25	2.61 Ratio
Concomitant+Mixed	Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine	HI (eTIV_a, H3N2) N=35, 25	2.21 Ratio

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.

Time frame: 21 days after second and third vaccinations (day 43 and day 403)

Arm	Measure	Group	Value (NUMBER)
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	5 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	2 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	2 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	2 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	12 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	20 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	1 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	2 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	3 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	8 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	2 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	6 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	6 Subjects
Concomitant Alone	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	8 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	8 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	3 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	1 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	6 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	7 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	1 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	21 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	11 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	16 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	1 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	5 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	4 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	8 Subjects
Concomitant+Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	5 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	3 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	5 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	8 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	3 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	16 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	2 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	9 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	11 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	14 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	9 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	0 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	5 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	1 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	17 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	21 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	9 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	4 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	3 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	6 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	7 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Concomitant+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	3 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	4 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	0 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	9 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	3 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	7 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	9 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	2 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	1 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	23 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	13 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	10 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	1 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	2 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	2 Subjects
Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	NA Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	8 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	3 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	4 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	20 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	0 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	0 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	0 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	1 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	20 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	7 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	9 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	6 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	4 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	8 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	12 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	4 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	10 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	0 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	2 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	3 Subjects
Mixed + Mixed	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	0 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	0 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	18 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	4 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	1 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	7 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	10 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	8 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	8 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	8 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	9 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	5 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	3 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	6 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	2 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	1 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	0 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	6 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	4 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	0 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	7 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	3 Subjects
Mixed+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	1 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	3 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	2 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	3 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	17 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	9 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	2 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	8 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	6 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	7 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	4 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	7 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	6 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	5 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	12 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	0 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	1 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	1 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
MF59-eH5N1+eTIV_a	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	3 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc	2 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc	7 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=50,48,47,51,48,47,47,43) 2nd vacc	4 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc	3 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc	0 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc	5 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=31,33,36,39,31,29,34,31) 3rd vacc	15 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=31,49,36,39,31,50,34,49) 3rd vacc	0 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc	2 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Chills (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc	1 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=50,48,47,51,48,47,47,43) 2nd vacc	3 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc	4 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Induration (N=31,33,36,39,31,29,34,31) 3rd vacc	8 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc	11 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc	1 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc	5 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc	13 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc	2 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Headache (N=31,32,36,39,31,29,34,32) 3rd vacc	7 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc	5 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Pain (N=50,48,47,51,48,47,47,43) 2nd vacc	16 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc	6 Subjects
eTIV_a+MF59-eH5N1	Number of Subjects Reporting Local and Systemic Reactions by Vaccination	Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc	3 Subjects

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.

Time frame: 21 days after booster vaccination (day 403)

Population: Full analysis set (FAS)

Arm	Measure	Group	Value (NUMBER)
Concomitant Alone	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	Seroprotection (HI) _MF59-H5N1 (N=35, 25)	26 Subjects
Concomitant Alone	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	Seroconversion (HI)_MF59-H5N1	25 Subjects
Concomitant Alone	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	Seroprotection (SRH)_MF59-H5N1 (N=35, 25)	50 Subjects
Concomitant Alone	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	Seroconversion (SRH)_MF59-H5N1 (N=35, 25)	21 Subjects
Concomitant Alone	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	Seroprotection (HI) - eTIV_a (H1N1) N=35, 25	33 Subjects
Concomitant Alone	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	Seroconversion (HI) - eTIV_a (H1N1) N=39, 25	17 Subjects
Concomitant Alone	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	Seroprotection (HI) - eTIV_a (H3N2) N=35, 25	35 Subjects
Concomitant Alone	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	Seroconversion (HI) - eTIV_a (H3N2) N=39, 25	12 Subjects
Concomitant Alone	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	Seroprotection (HI) - eTIV_a (B) N=35, 25	31 Subjects
Concomitant Alone	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	Seroconversion (HI) - seTIV_a (B) N=35, 25	6 Subjects
Concomitant+Mixed	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	Seroconversion (HI) - eTIV_a (H3N2) N=39, 25	5 Subjects
Concomitant+Mixed	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	Seroprotection (HI) _MF59-H5N1 (N=35, 25)	16 Subjects
Concomitant+Mixed	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	Seroconversion (HI) - eTIV_a (H1N1) N=39, 25	10 Subjects
Concomitant+Mixed	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	Seroconversion (HI)_MF59-H5N1	15 Subjects
Concomitant+Mixed	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	Seroconversion (HI) - seTIV_a (B) N=35, 25	4 Subjects
Concomitant+Mixed	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	Seroprotection (SRH)_MF59-H5N1 (N=35, 25)	7 Subjects
Concomitant+Mixed	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	Seroprotection (HI) - eTIV_a (H3N2) N=35, 25	25 Subjects
Concomitant+Mixed	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	Seroconversion (SRH)_MF59-H5N1 (N=35, 25)	10 Subjects
Concomitant+Mixed	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	Seroprotection (HI) - eTIV_a (B) N=35, 25	18 Subjects
Concomitant+Mixed	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	Seroprotection (HI) - eTIV_a (H1N1) N=35, 25	24 Subjects

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026

Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)

Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine

Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)

Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)

Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)

Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)

Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)

Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine

Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine

Number of Subjects Reporting Local and Systemic Reactions by Vaccination

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