Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

A Phase III, Randomized, Controlled, Observer-blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted With MF59 (Fluad-H5N1) in Adult and Elderly Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00841763

Enrollment

3647

Registered

2009-02-11

Start date

2008-10-31

Completion date

2009-11-30

Last updated

2021-04-23

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

Conditions

Pandemic Influenza Disease

Keywords

virus, pandemic influenza, vaccine

Brief summary

The present study, phase III, randomized, controlled, observer-blind, multicenter study, will evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a population of healthy adult and elderly subjects.

Interventions

BIOLOGICALPlacebo (PL)

One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm.

BIOLOGICALTrivalent influenza virus vaccine (TIV)

A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm.

BIOLOGICALAdjuvanted monovalent influenza virus vaccine (aH5N1)

Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle.

BIOLOGICALAdjuvanted trivalent influenza virus vaccine (aTIV)

Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects 18 years of age and older who were mentally competent and who had signed an informed consent form after having received a detailed explanation of the study protocol; * In good health as determined by: 1. medical history, 2. physical examination, 3. clinical judgment of the Investigator; * Able to understand and comply with all study procedures and to complete study diaries, could be contacted, and were available for study visits;

Exclusion criteria

* Receipt of another investigational agent within 4 weeks; * Laboratory-confirmed influenza disease within 6 months prior to Visit 1; * Receipt of influenza vaccination for current season 2008/2009; * Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) within the past 7 days; * Experienced fever (defined as axillary temperature ≥38.0°C) within 7 days prior to Visit 1; * Pregnant or breastfeeding; * Females of childbearing potential who were sexually active and had not used or did not plan or refused to use an acceptable method of birth control during the active phase of the study (at least up to three weeks after last vaccine injection); * Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis); diabetes mellitus type I and type II; diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas or infections; advanced arteriosclerotic disease; severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and 4; acute or progressive hepatic disease and renal disease; congestive heart failure; Body Mass Index (BMI) ≥35 kg/m2 where BMI reflects obesity and not high muscle mass; * History of progressive or severe neurologic disorders, of any neurological symptoms or signs, or anaphylactic shock following administration of any study vaccine; * Bleeding diathesis; * Surgery planned during the study period; * Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccines; * Known or suspected impairment/alteration of immune function, for example, resulting from: 1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy) or other immunosuppressive agents within the past 60 days and for the full length of the study; 2. receipt of immunostimulants; 3. receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; 4. suspected or known HIV infection or HIV-related disease; * Receipt of non study vaccines (with the exception of post-exposure vaccination in a medical emergency, e.g. hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination; * History of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives; * Members of research staff and their relatives; * Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Up to 6 days after each vaccination.	To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.
Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.	Upto Day 224 post vaccination	To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of \<=0.1%, & uncommon AEs in elderly, i.e. occurring at a frequency of \<=1% of subjects.

Secondary

Measure	Time frame	Description
Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).	Day 22, Day 43, Day 64	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, in terms of GMAs as determined by Single Radial Hemolysis (SRH) assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.
Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43/Day 22, Day 64/Day 22	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen,in terms of GMRs against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.
Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22, Day 43 and Day 64	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm\^2, as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.
Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43/Day 22 and Day 64/Day 22	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays.
GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22, Day 43 and Day 64	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.
GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22, Day 43 and Day 64	To evaluate the immunogenicity of two doses of adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMAs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.
GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22 and Day 64/Day 22	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMRs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI, MN and SRH assays.
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Up to 6 days after each vaccination.	To evaluate the safety and tolerability profile of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (aTIV), in terms of the number of subjects who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.
Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22 and Day 64/Day 22)	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays.
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22, Day 43 and Day 64	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Days 22, Day 43 and Day 64.
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22, Day 43 and Day 64	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Day 22, Day 43 and Day 64.
Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains.	Day 43/Day 22 and Day 64/Day 22	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22.
Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains.	Day 43/Day 22 and Day 64/Day 22	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against Heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22.
Number of Subjects Reporting Unsolicited AEs After Vaccination.	Day 1 through Day 224 post vaccination	The number of subjects reporting any unsolicited AEs any, Possibly/probably related AEs, serious adverse events (SAEs), AEs leading to withdrawal (WD), AEs leading to death from Day 1 through Day 224 post vaccination.
Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22, Day 43 and Day 64	To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm\^2 as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Vaccine on Day 22, Day 43, Day 64.
Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22, Day 43, Day 64	To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the homologous A/Vietnam/1194/2004 strain, as determined by Hemagglutination Inhibition (HI) assay and Microneutralization (MN) assay.

Countries

Finland, Germany

Participant flow

Recruitment details

Subjects were enrolled from 27 centers across Finland and Germany.

Pre-assignment details

All subjects enrolled were included in the trial.

Participants by arm

Arm	Count
TIV + aH5N1 First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	2,911
PL+ aTIV First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	735
Total	3,646

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Administrative Reasons	3	1	0	0
Overall Study	Adverse Event	9	10	3	2
Overall Study	Lost to Follow-up	63	25	0	0
Overall Study	Protocol Violation	20	3	1	0
Overall Study	Unable to Classify	7	1	0	0
Overall Study	Withdrawal by Subject	60	17	4	1

Baseline characteristics

Characteristic	TIV + aH5N1	Total	PL+ aTIV
Age, Customized <= 60 years	40.7 Years STANDARD_DEVIATION 11.6	40.7 Years STANDARD_DEVIATION 11.7	40.5 Years STANDARD_DEVIATION 12
Age, Customized >60 years	61.9 Years STANDARD_DEVIATION 1.4	61.9 Years STANDARD_DEVIATION 1.5	62.1 Years STANDARD_DEVIATION 1.8
Sex/Gender, Customized Female (<=60 yrs)	1502 participants	1890 participants	388 participants
Sex/Gender, Customized Female (>60 yrs)	109 participants	137 participants	28 participants
Sex/Gender, Customized Male (<=60 yrs)	1190 participants	1481 participants	291 participants
Sex/Gender, Customized Male (>60 yrs)	110 participants	138 participants	28 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	2,301 / 2,680	590 / 676	176 / 222	45 / 56
serious Total, serious adverse events	40 / 2,680	9 / 676	1 / 222	2 / 56

Outcome results

Primary

Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.

To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of \<=0.1%, & uncommon AEs in elderly, i.e. occurring at a frequency of \<=1% of subjects.

Time frame: Upto Day 224 post vaccination

Population: The analysis was performed on the Safety set population.

Arm	Measure	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.	2692 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.	679 Participants
TIV + aH5N1 (>60 Yrs)	Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.	219 Participants
PL+ aTIV (>60 Yrs)	Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.	56 Participants

Primary

Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.

To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.

Time frame: Up to 6 days after each vaccination.

Population: The analysis was performed on the Safety Set population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Local reactions	1755 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site ecchymosis	237 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site erythema	652 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site induration	549 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site swelling	409 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site pain	1537 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Systemic reactions	1387 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Chills	342 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Malaise	347 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Myalgia	869 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Arthralgia	188 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Nausea	193 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Headache	668 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Sweating	237 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Fatigue	638 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Fever ≥ 38°C	28 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Stayed at home	64 Participants
TIV + aH5N1 (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Analgesic Antipyretic medi. used	361 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Sweating	658 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Local reactions	502 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Myalgia	277 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site ecchymosis	78 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Analgesic Antipyretic medi. used	114 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site erythema	206 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Arthralgia	79 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site induration	181 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Fatigue	188 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site swelling	162 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Nausea	64 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Injection site pain	448 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Stayed at home	22 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Systemic reactions	386 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Headache	189 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Chills	118 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Fever ≥ 38°C	12 Participants
PL+ aTIV (18-60 Yrs)	Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.	Malaise	130 Participants

Secondary

Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, in terms of GMAs as determined by Single Radial Hemolysis (SRH) assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.

Time frame: Day 22, Day 43, Day 64

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).	Day 22 (baseline)	11 Areas (mm^2)
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).	Day 43	21 Areas (mm^2)
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).	Day 64	43 Areas (mm^2)
PL+ aTIV (18-60 Yrs)	Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).	Day 22 (baseline)	13 Areas (mm^2)
PL+ aTIV (18-60 Yrs)	Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).	Day 43	20 Areas (mm^2)
PL+ aTIV (18-60 Yrs)	Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).	Day 64	37 Areas (mm^2)

Secondary

Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen,in terms of GMRs against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.

Time frame: Day 43/Day 22, Day 64/Day 22

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 to Day 22 (N= 196,201,197,207,197,208)	2.25 Ratios
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 to Day 22	7.1 Ratios
PL+ aTIV (18-60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 to Day 22 (N= 196,201,197,207,197,208)	2.14 Ratios
PL+ aTIV (18-60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 to Day 22	5.15 Ratios
TIV + aH5N1 (>60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 to Day 22	6.21 Ratios
TIV + aH5N1 (>60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 to Day 22 (N= 196,201,197,207,197,208)	1.58 Ratios
PL+ aTIV (>60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 to Day 22 (N= 196,201,197,207,197,208)	1.63 Ratios
PL+ aTIV (>60 Yrs)	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 to Day 22	4.42 Ratios
TIV + aH5N1 (18-60 Yrs) SRH Assay	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 to Day 22 (N= 196,201,197,207,197,208)	1.95 Ratios
TIV + aH5N1 (18-60 Yrs) SRH Assay	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 to Day 22	4.03 Ratios
TIV + aH5N1 (>60 Yrs) SRH Assay	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 to Day 22	2.9 Ratios
TIV + aH5N1 (>60 Yrs) SRH Assay	Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 to Day 22 (N= 196,201,197,207,197,208)	1.57 Ratios

Secondary

Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the homologous A/Vietnam/1194/2004 strain, as determined by Hemagglutination Inhibition (HI) assay and Microneutralization (MN) assay.

Time frame: Day 22, Day 43, Day 64

Population: The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset - All subjects in the enrolled population who were in the immunogenicity subset and who actually received at least one dose of AdjPanH5N1 or Adj Seasonal, and provided at leatr one evaluable serum sample both before and after baseline.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	6.17 Titers
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	44 Titers
TIV + aH5N1 (18-60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	14 Titers
PL+ aTIV (18-60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	6.98 Titers
PL+ aTIV (18-60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	36 Titers
PL+ aTIV (18-60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	15 Titers
TIV + aH5N1 (>60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	17 Titers
TIV + aH5N1 (>60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	11 Titers
TIV + aH5N1 (>60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	65 Titers
PL+ aTIV (>60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	10 Titers
PL+ aTIV (>60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	45 Titers
PL+ aTIV (>60 Yrs)	Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	17 Titers

Secondary

GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

To evaluate the immunogenicity of two doses of adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMAs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.

Time frame: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
TIV + aH5N1 (18-60 Yrs)	GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	9.89 Areas (mm^2)
TIV + aH5N1 (18-60 Yrs)	GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	14 Areas (mm^2)
TIV + aH5N1 (18-60 Yrs)	GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	23 Areas (mm^2)
PL+ aTIV (18-60 Yrs)	GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	12 Areas (mm^2)
PL+ aTIV (18-60 Yrs)	GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	14 Areas (mm^2)
PL+ aTIV (18-60 Yrs)	GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	20 Areas (mm^2)

Secondary

GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMRs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI, MN and SRH assays.

Time frame: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
TIV + aH5N1 (18-60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	1.92 Ratios
TIV + aH5N1 (18-60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	1.33 Ratios
PL+ aTIV (18-60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	1.79 Ratios
PL+ aTIV (18-60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	1.29 Ratios
TIV + aH5N1 (>60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	2.77 Ratios
TIV + aH5N1 (>60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	1.39 Ratios
PL+ aTIV (>60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	2.01 Ratios
PL+ aTIV (>60 Yrs)	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	1.29 Ratios
TIV + aH5N1 (18-60 Yrs) SRH Assay	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	1.44 Ratios
TIV + aH5N1 (18-60 Yrs) SRH Assay	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	2.37 Ratios
TIV + aH5N1 (>60 Yrs) SRH Assay	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	1.74 Ratios
TIV + aH5N1 (>60 Yrs) SRH Assay	GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	1.25 Ratios

Secondary

GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.

Time frame: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
TIV + aH5N1 (18-60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	6.03 Titers
TIV + aH5N1 (18-60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	12 Titers
TIV + aH5N1 (18-60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	8.03 Titers
PL+ aTIV (18-60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	6.85 Titers
PL+ aTIV (18-60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	12 Titers
PL+ aTIV (18-60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	8.87 Titers
TIV + aH5N1 (>60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	15 Titers
TIV + aH5N1 (>60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	11 Titers
TIV + aH5N1 (>60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	30 Titers
PL+ aTIV (>60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	11 Titers
PL+ aTIV (>60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	23 Titers
PL+ aTIV (>60 Yrs)	GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	15 Titers

Secondary

Number of Subjects Reporting Unsolicited AEs After Vaccination.

The number of subjects reporting any unsolicited AEs any, Possibly/probably related AEs, serious adverse events (SAEs), AEs leading to withdrawal (WD), AEs leading to death from Day 1 through Day 224 post vaccination.

Time frame: Day 1 through Day 224 post vaccination

Population: Analysis was done on safety population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	At least possibly related AEs	357 Subjects
TIV + aH5N1 (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	SAEs	45 Subjects
TIV + aH5N1 (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Any AEs	1329 Subjects
TIV + aH5N1 (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Deaths	0 Subjects
TIV + aH5N1 (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	AEs Leading to Premature Withdrawal	4 Subjects
PL+ aTIV (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	At least possibly related AEs	103 Subjects
PL+ aTIV (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Any AEs	335 Subjects
PL+ aTIV (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	SAEs	10 Subjects
PL+ aTIV (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	AEs Leading to Premature Withdrawal	4 Subjects
PL+ aTIV (18-60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Deaths	0 Subjects
TIV + aH5N1 (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	At least possibly related AEs	25 Subjects
TIV + aH5N1 (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Any AEs	103 Subjects
TIV + aH5N1 (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Deaths	1 Subjects
TIV + aH5N1 (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	SAEs	4 Subjects
TIV + aH5N1 (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	AEs Leading to Premature Withdrawal	2 Subjects
PL+ aTIV (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	SAEs	3 Subjects
PL+ aTIV (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	AEs Leading to Premature Withdrawal	1 Subjects
PL+ aTIV (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	At least possibly related AEs	13 Subjects
PL+ aTIV (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Deaths	0 Subjects
PL+ aTIV (>60 Yrs)	Number of Subjects Reporting Unsolicited AEs After Vaccination.	Any AEs	29 Subjects

Secondary

Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against Heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22.

Time frame: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains.	Day 43/Day 22	9 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains.	Day 64/Day 22	36 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains.	Day 43/Day 22	9 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains.	Day 64/Day 22	25 Percentages of subjects

Secondary

Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22.

Time frame: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains.	Day 43/Day 22	14 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains.	Day 64/Day 22	65 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains.	Day 43/Day 22	18 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains.	Day 64/Day 22	55 Percentages of subjects

Secondary

Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

Time frame: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43/Day 22	23 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64/Day 22	56 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64/Day 22	50 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43/Day 22	22 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43/Day 22	37 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64/Day 22	78 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43/Day 22	23 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64/Day 22	63 Percentages of subjects

Secondary

Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays.

Time frame: Day 43/Day 22 and Day 64/Day 22)

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	9 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	19 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	19 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	8 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	18 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	49 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43/Day 22	10 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64/Day 22	32 Percentages of subjects

Secondary

Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm\^2 as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Vaccine on Day 22, Day 43, Day 64.

Time frame: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	3 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	23 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	11 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	5 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	25 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	15 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	30 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	16 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	59 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (baseline)	23 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64	48 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43	32 Percentages of subjects

Secondary

Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm\^2, as determined by HI and SRH assays. GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.

Time frame: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	6 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	61 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	30 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	8 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	57 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	31 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	48 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	19 Percentages of subjects
TIV + aH5N1 (>60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	91 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (baseline)	25 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64	82 Percentages of subjects
PL+ aTIV (>60 Yrs)	Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43	46 Percentages of subjects

Secondary

Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Day 22, Day 43 and Day 64.

Time frame: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43 (MN titer ≥ 20)	23 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64 (MN titer ≥ 40)	39 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (MN titer ≥ 40)	3 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (MN titer ≥ 80)	2 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64 (MN titer ≥ 20; N= 197, 208)	59 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43 (MN titer ≥ 80)	8 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43 (MN titer ≥ 40)	13 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64 (MN titer ≥ 80)	19 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (MN titer≥20)	5 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64 (MN titer ≥ 80)	12 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (MN titer≥20)	9 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43 (MN titer ≥ 20)	21 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64 (MN titer ≥ 20; N= 197, 208)	47 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (MN titer ≥ 40)	3 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43 (MN titer ≥ 40)	14 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 64 (MN titer ≥ 40)	30 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 22 (MN titer ≥ 80)	0.012 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.	Day 43 (MN titer ≥ 80)	6 Percentages of subjects

Secondary

Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Days 22, Day 43 and Day 64.

Time frame: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 (MN titer ≥ 20)	27 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 (MN titer ≥ 40)	67 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (MN titer ≥ 40)	2 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (MN titer ≥ 80)	1 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 (MN titer ≥ 20)	79 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 (MN titer ≥ 80)	9 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 (MN titer ≥ 40)	16 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 (MN titer ≥ 80)	50 Percentages of subjects
TIV + aH5N1 (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (MN titer ≥ 20)	3 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 (MN titer ≥ 80)	33 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (MN titer ≥ 20)	2 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 (MN titer ≥ 20)	25 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 (MN titer ≥ 20)	72 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (MN titer ≥ 40)	1 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 (MN titer ≥ 40)	19 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 64 (MN titer ≥ 40)	57 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 22 (MN titer ≥ 80)	0 Percentages of subjects
PL+ aTIV (18-60 Yrs)	Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.	Day 43 (MN titer ≥ 80)	13 Percentages of subjects

Secondary

The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.

To evaluate the safety and tolerability profile of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (aTIV), in terms of the number of subjects who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.

Time frame: Up to 6 days after each vaccination.

Population: The analysis was performed on the Safety set population.

Arm	Measure	Group	Value (NUMBER)
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Myalgia	869 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Malaise (N= 2610,658,214,54)	347 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site pain (N= 2610,658,214,54)	1537 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Analg. Antipyr. Medi. used	361 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Chills	342 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Systemic reactions	1387 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fever ≥38°C	28 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fatigue (N= 2610,658,214,54)	638 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site erythema	652 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Local reactions	1755 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Sweating	237 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Headache (N= 2610,658,214,54)	668 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site induration (N= 2610,658,214,54)	549 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Stayed at home	64 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Nausea	193 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Arthralgia (N= 2610,658,214,54)	188 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site swelling	409 Subjects
TIV + aH5N1 (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site ecchymosis (N= 2610,658,214,54)	237 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site erythema	206 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Local reactions	502 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site ecchymosis (N= 2610,658,214,54)	78 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site induration (N= 2610,658,214,54)	181 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site swelling	162 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site pain (N= 2610,658,214,54)	448 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Systemic reactions	386 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Chills	118 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Malaise (N= 2610,658,214,54)	130 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Myalgia	277 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Arthralgia (N= 2610,658,214,54)	79 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Nausea	64 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Headache (N= 2610,658,214,54)	189 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Sweating	63 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fatigue (N= 2610,658,214,54)	188 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fever ≥38°C	12 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Stayed at home	22 Subjects
PL+ aTIV (18-60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Analg. Antipyr. Medi. used	114 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site swelling	22 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Myalgia	59 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Arthralgia (N= 2610,658,214,54)	15 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site induration (N= 2610,658,214,54)	22 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Analg. Antipyr. Medi. used	27 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Nausea	14 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Stayed at home	3 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Headache (N= 2610,658,214,54)	38 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site erythema	45 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Sweating	10 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Local reactions	115 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fatigue (N= 2610,658,214,54)	27 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site ecchymosis (N= 2610,658,214,54)	23 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Systemic reactions	95 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site pain (N= 2610,658,214,54)	87 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Chills	29 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fever ≥38°C	1 Subjects
TIV + aH5N1 (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Malaise (N= 2610,658,214,54)	25 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Systemic reactions	26 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fever ≥38°C	1 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Sweating	2 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Myalgia	16 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site induration (N= 2610,658,214,54)	10 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Local reactions	30 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site ecchymosis (N= 2610,658,214,54)	7 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Arthralgia (N= 2610,658,214,54)	5 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site swelling	6 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Analg. Antipyr. Medi. used	6 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Fatigue (N= 2610,658,214,54)	7 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Nausea	3 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site erythema	14 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Injection site pain (N= 2610,658,214,54)	21 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Malaise (N= 2610,658,214,54)	6 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Headache (N= 2610,658,214,54)	10 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Chills	10 Subjects
PL+ aTIV (>60 Yrs)	The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.	Stayed at home	1 Subjects

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

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Brief summary

Related papers

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Study design

Eligibility

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Exclusion criteria

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Secondary

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Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.

Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine.

Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1).

Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

Number of Subjects Reporting Unsolicited AEs After Vaccination.

Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains.

Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains.

Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.

Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain.

The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV.