Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives:

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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: (Flu Q-Pan-005 PRI) Title: A trial to evaluate the safety and immunogenicity of monovalent A/turkey/Turkey/1/05 (H5N1) vaccine antigen with AS03 adjuvant following a single priming dose of monovalent A/Indonesia/5/05 (H5N1) vaccine antigen with AS03 adjuvant in adults 18 years of age or older. A/turkey/Turkey/1/05 H5N1 vaccine (Flu 1): GlaxoSmithKline (GSK) Biologicals pandemic H5N1 influenza vaccine with A/turkey/Turkey/1/05 antigen Pumarix TM (Flu 2): GSK Biologicals pandemic H5N1 influenza vaccine with A/Indonesia/5/2005 antigen (Quebec manufacturing process) Rationale: This study assessed the safety and immunogenicity of heterologous booster vaccination with Flu 1 vaccine given approximately 6 or 18 months after a single priming dose of Flu 2 vaccine in adults 18 years of age or older. A H5N1 naïve subject group was used as an immunogenicity control group. Phase: II Study Period: 15 July 2008 until 22 April 2010 (last visit Day 591) 15 July 2008 until 21 February 2011 (Day 909) Study Design: Observer-blind, placebo-controlled, randomized (1:1:1:1:1:1:1), multi-center trial with 7 parallel groups. Centers: 13 centers in 2 countries (Canada and the United States) Indication: Immunization against influenza disease caused by an influenza A virus with pandemic potential, sub-type H5N1. Treatment: The treatment groups were as follows: Flu2-Flu1-F1-PBS : subjects received at Day 0 1 dose of Flu 2 vaccine formulation 1, at Day dose of Flu 1 vaccine formulation 1 and at Day dose of placebo (phosphate buffered saline [PBS]) Flu2-Flu1-F2-PBS : subjects received at Day 0 1 dose of Flu 2 vaccine formulation 2, at Day dose of Flu 1 vaccine formulation 2 and at Day dose of PBS Flu1-F3 : subjects received at Day 0 1 dose of Flu 2 vaccine formulation 3, at Day dose of PBS and at Day dose of Flu 1 vaccine formulation 3 Flu1-F1 : subjects received at Day 0 1 dose of Flu 2 vaccine formulation 1, at Day dose of PBS and at Day dose of Flu 1 vaccine formulation 1 Flu1-F4 : subjects received at Day 0 1 dose of Flu 2 vaccine formulation 4, at Day dose of PBS and at Day dose of Flu 1 vaccine formulation 4 Flu1-F2 : subjects received at Day 0 1 dose of Flu 2 vaccine formulation 2, at Day dose of PBS and at Day dose of Flu 1 vaccine formulation 2 PBS-Flu1-Flu1-F3 : subjects received at Day 0 1 dose of PBS, at Day 182 and Day dose of Flu 1 vaccine formulation 3 All vaccines and PBS were administered intramuscularly in the non-dominant deltoid at Day 0 and Day 549 and in the dominant deltoid at Day 182. Objectives: To assess whether a single dose of Flu 1 vaccine was more immunogenic when given to subjects who 18 months previously had received a single priming dose of Flu 2 vaccine than when given to H5N1-naïve subjects based on hemagglutination inhibition (HI) seroconversion rates (SCRs) and geometric mean titers (GMTs). Criteria for Evaluation: This objective was to compare the immune responses to Flu 1 vaccine in primed and non-primed vaccine recipients based on the difference in HI antibody SCRs and the ratio of GMTs. For the analysis, booster vaccination was to occur 549 days following the single dose of Flu 2 vaccine. Serologic response was to be measured on Day 559, 10 days following booster vaccination. Control subjects were to receive their first dose of vaccine on Day 182, with SCR assessed on Day 192. Superiority of single-dose booster vaccination over a single dose primary vaccination was established if: a. the lower bound of the 97.5% confidence interval (CI) for the difference in SCR (booster vaccine group* minus H5N1 naïve subject group*) exceeded an absolute difference of 15%, and b. the lower bound of the 97.5% CI for the GMT ratio (booster vaccine group* to H5N1 naïve subject group*) exceeded 2.0. To describe and contrast the safety of Flu 1 vaccine in terms of solicited local and general symptoms, unsolicited

2 adverse events (AEs), and serious adverse events (SAEs) in subjects previously vaccinated with Flu 2 vaccine and in H5N1 naïve control subjects. *Booster vaccine group was any group receiving Flu 1 vaccine as a booster at Day 549. The H5N1 naïve subject group was the PBS-Flu1-Flu1-F3. Primary Outcome/Efficacy Variable: Immunogenicity A/turkey/Turkey/1/05-homologous virus antibody response, as assessed by HI measured on Day 182 and Day 192 for primary H5N1 vaccine recipients (controls = PBS-Flu1-Flu1-F3 ) or Day 549 and Day 559 for subjects having received a Month 18 booster dose of Flu 1 vaccine Safety The occurrence of specifically-solicited local and general signs and symptoms during a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each dose of vaccine or placebo. The occurrence of all unsolicited AEs during a 42-day follow-up period after each vaccination. The occurrence of SAEs and medically-attended events (MAEs) during the entire study period (Day 0 to 909). Secondary Outcome/Efficacy Variable(s): Booster Flu 1 vaccine (A/turkey/Turkey/1/05)-homologous virus antibody response, as assessed by HI measured on Day 182 (day of primary Flu 1 vaccination or booster Flu 1 vaccination) and Day 192 (10 days after primary Flu 1 vaccination or booster Flu 1 vaccination) Change in the proportion of subjects with A/turkey/Turkey/1/05 HI titers 1:40 from Day 182 to Day 192 or Day 549 to Day 559, and from Day 182 to Day 224 or Day 549 to Day 591, Geometric mean fold-rise (GMFR) in A/turkey/Turkey/1/05 HI titers from Day 182 to Day 192 or Day 549 to Day 559, and from Day 182 to Day 224 or Day 549 to Day 591, The A/turkey/Turkey/1/05 HI SCR from Day 182 to Day 224 or from Day 549 to Day 591, 42 days post boost or primary dose, The A/turkey/Turkey/1/05 HI GMT and proportion of subjects with A/turkey/Turkey/1/05 HI titer 1:40 on Days 0, 182, 192 (if provided Flu 1 vaccine on Day 182), 224 (if provided Flu 1 vaccine on Day 182), 549, 559 (if provided Flu 1 vaccine on Day 549), 591 (if provided Flu 1 vaccine on Day 549), and 729, The A/Indonesia/5/05 HI GMT and proportion of subjects with A/Indonesia/5/05 HI titer 1:40 on Days 0, 10, 42, 182, 549, and 559, The A/Indonesia/5/05 HI SCR from Day 0 to Day 10 and from Day 0 to Day 42. Statistical Methods: The analyses were performed on the Total Vaccinated cohort and the According-To-Protocol (ATP) cohort for immunogenicity. - The Total Vaccinated cohort included all subjects who received at least one dose of vaccine and for whom any postvaccination data were available. - The ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom a complete set of data concerning immunogenicity primary outcome variables was available. This implied that all subjects must have had at least Day 182 and 192 or Day 549 and 559 HI titer results for the A/turkey/Turkey/1/05 virus. - The ATP cohort for immunogenicity at Day 729 included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom a complete set of data concerning immunogenicity primary outcome variables was available till Day 729 for any virus strain. Analysis of Immunogenicity: The analysis of immunogenicity was performed on the ATP cohort for immunogenicity and the ATP cohort for immunogenicity at Day 729. Inferential analysis Statistical tests were performed sequentially for boost effect, defined as a SCR difference > 15%, and as a GMT ratio > 2, first for a boost effect by testing Flu1-F3 versus PBS-Flu1-Flu1-F3, and Flu1-F4 versus PBS-Flu1-Flu1-F3. If both comparisons successfully established superior immunogenicity for the prime-boost groups, a test for Flu1-F1 versus PBS-Flu1-Flu1-F3 and Flu1-F2 versus PBS-Flu1-Flu1-F3 was performed. Immune response to A/turkey/Turkey/1/05 at 6 months was assessed by computation of the HI SCR 10 days following the booster vaccination, defined as a pre-vaccination titer recorded as < 1:10 for HI and a post-vaccination reciprocal titer 1:40, or a pre-vaccination reciprocal titer 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer. Descriptive statistics

3 To evaluate homologous virus immune response in naïve versus primed vaccine groups, seroprotection rate (SPR) was calculated for A/turkey/Turkey/1/05 for Days 0, 182, 192 and 224 or for Days 0, 549, 559, and 591. The proportion of subjects with a serum reciprocal HI antibody titer 1:40 at each sampling day along with 95% CIs was presented. Furthermore, GMFRs and corresponding 95% CIs were tabulated for Days 192 and 224 or Days 559 and 591 for the A/turkey/Turkey/1/05 strain relative to the Day 182 or Day 549 reciprocal HI titer. For each vaccine group, the immune response to A/turkey/Turkey/1/05 was also assessed by computation of the HI SCR at Days 224 and 591 relative to Day 182 or Day 549; SCR rates and 95% CIs of these rates were tabulated. For Day 224 or Day 591, GMTs for each vaccine group were also to be tabulated along with 95% CIs. Additional analyses focused on A/Indonesia/5/05 SCRs from Day 0 to Days 10 and 42 and SPRs and GMTs at each of the sample time points for A/turkey/Turkey/5/05, A/Indonesia/5/05 and A/Vietnam/1194/04. Demographics Analysis of Safety : The analysis was performed on the Total Vaccinated cohort. For each solicited symptom, the percentage of subjects with the symptom and its exact 95% CI was summarized for each group, per dose and across doses. The same tabulation was performed for grade 3 solicited symptoms and general solicited symptoms assessed by the investigators as related to the study vaccination. The percentage of subjects reporting unsolicited adverse events within 42 days following vaccination was summarized per group according to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. SAEs and MAEs were tabulated according to MedDRA preferred terms up to Day 909. Study Population: Male or female subjects 18 years of age or older at the time of the first vaccination, with a stable health status as defined by the absence of a health event satisfying the definition of an SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment and with no previous administration of any H5N1 vaccine. Females of child-bearing potential had a negative pregnancy test prior to vaccination and needed a history of reliable contraceptive practices. Written informed consent was obtained from each subject prior to subject entry. Number of subjects Flu2-Flu1-F1-PBS Flu2-Flu1-F2- PBS Flu1- F3 Flu1-F1 Planned, N Randomized, N (Total Vaccinated cohort) Completed to Day 224, n (%) 110 (91.7) 112 (92.6) 111 (93.3) 110 (92.4) Completed to Day 591, n (%) 95 (79.2) 101 (83.5) 103 (86.6) 99 (83.2) Completed to Day 729, n (%) 91 (75.8) 97 (80.2) 102 (86.6) 96 (80.7) Completed to Day 909, n (%) 88 (73.3) 96 (79.3) 99 (83.2) 96 (80.7) Total Number Subjects Withdrawn, n (%) 32 (26.7) 25 (20.7) 20 (16.8) 23 (19.3) Withdrawn due to Adverse Events, n (%) 5 (4.2) 1 (0.9) 2 (1.7) 2 (1.7) Withdrawn due to Lack of Efficacy, n (%) Not applicable Not applicable Not applicable Not applicable Withdrawn for other reasons, n (%) 27 (22.5) 24 (19.8) 18 (15.1) 21 (17.6) Demographics Flu2-Flu1-F1-PBS Flu2-Flu1-F2- PBS Flu1- F3 Flu1-F1 N (Total Vaccinated cohort) Females:Males 80:40 73:48 69:50 70:49 Mean Age, years (SD) 49.8 (18.01) 49.6 (17.93) 50.7 (17.67) 49.2 (17.75) White - Caucasian / European heritage, n (%) 104 (86.7) 104 (86.0) 104 (87.4) 106 (89.1) Number of subjects Flu1- Flu1-F2 PBS-Flu1-Flu1-F3 F4 Planned, N Randomized, N (Total Vaccinated cohort) Completed to Day 224, n (%) 118 (96.7) 111 (92.5) 114 (95.0) Completed to Day 591, n (%) 98 (80.3) 89 (74.2) 93 (77.5) Completed to Day 729, n (%) 98 (80.3) 88 (74.2) 92 (76.7) Completed to Day 909, n (%) 95 (77.9) 86 (71.7) 92 (76.7) Total Number Subjects Withdrawn, n (%) 27 (22.1) 34 (28.3) 28 (23.3) Withdrawn due to Adverse Events, n (%) 1 (0.8) 4 (3.3) 4 (3.3) Withdrawn due to Lack of Efficacy, n (%) Not applicable Not applicable Not applicable Withdrawn for other reasons, n (%) 26 (21.3) 30 (25.0) 24 (20.0) Flu1- F4 Flu1-F2 PBS-Flu1-Flu1-F3

4 N (Total Vaccinated cohort) Females:Males 68:54 70:50 75:45 Mean Age, years (SD) 50.3 (17.77) 50.1 (18.92) 50.0 (18.03) White - Caucasian / European heritage, n (%) 103 (84.4) 108 (90.0) 102 (85.0) Primary Efficacy Results: Difference in HI SCRs between Flu1-F3 and PBS-Flu1-Flu1-F3 (control group) against A/turkey/Turkey/1/05 at 10 days after the first Flu 1 vaccine administration (ATP cohort for immunogenicity) Antibody Flu1-F3 PBS-Flu1-Flu1-F3 Difference in SCR (Flu1-F3 minus PBS-Flu1-Flu1-F3 ) 97.5% CI N n % N n % % LL* UL A/turkey/Turkey/1/ SCR defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer 1:40, or a pre-vaccination reciprocal HI titer 1:10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. N = Number of subjects with available results n/% = Number/percentage of subjects with titer within the specified range 97.5% CI = Unstandard asymptotic 97.5% confidence interval; LL = lower limit, UL = upper limit *Superiority criterion: LL of the 97.5% CI for the difference in SCR > 15% Primary Efficacy Results: Difference in HI SCRs between Flu1-F4 and PBS-Flu1-Flu1-F3 (control group) against A/turkey/Turkey/1/05 at 10 days after the first Flu 1 vaccine administration (ATP cohort for immunogenicity) Antibody Flu1-F4 PBS-Flu1-Flu1-F3 Difference in SCR (Flu1-F4 minus PBS-Flu1-Flu1-F3 ) 97.5% CI N n % N n % % LL* UL A/turkey/Turkey/1/ SCR defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer 1:40, or a pre-vaccination reciprocal HI titer 1:10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. N = Number of subjects with available results n/% = Number/percentage of subjects with titer within the specified range 97.5% CI = Unstandard asymptotic 97.5% confidence interval; LL = lower limit, UL = upper limit *Superiority criterion: LL of the 97.5% CI for the difference in SCR > 15% Primary Efficacy Results: Difference in HI SCRs between Flu1-F1 and PBS-Flu1-Flu1-F3 (control group) against A/turkey/Turkey/1/05 at 10 days after the first Flu 1 vaccine administration (ATP cohort for immunogenicity) Antibody Flu1-F1 PBS-Flu1-Flu1-F3 Difference in SCR (Flu1-F1 minus PBS-Flu1-Flu1-F3 ) 97.5% CI N n % N n % % LL* UL A/turkey/Turkey/1/ SCR defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer 1:40, or a pre-vaccination reciprocal HI titer 1:10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. N = Number of subjects with available results n/% = Number/percentage of subjects with titer within the specified range 97.5% CI = Unstandard asymptotic 97.5% confidence interval; LL = lower limit, UL = upper limit Total = Subjects either seropositive or seronegative at pre-vaccination *Superiority criterion: LL of the 97.5% CI for the difference in SCR > 15% Primary Efficacy Results: Difference in HI SCRs between Flu1-F2 and PBS-Flu1-Flu1-F3 (control group) against A/turkey/Turkey/1/05 at 10 days after the first Flu 1 vaccine administration (ATP cohort for immunogenicity) Antibody Flu1-F2 PBS-Flu1-Flu1-F3 Difference in SCR (Flu1-F2 minus PBS-Flu1-Flu1-F3 ) 97.5% CI N n % N n % % LL* UL A/turkey/Turkey/1/ SCR defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer 1:40, or a pre-vaccination reciprocal HI titer 1:10 and at least a 4-fold increase in post vaccination reciprocal

5 titer against the vaccine virus. N = Number of subjects with available results n/% = Number/percentage of subjects with titer within the specified range 97.5% CI = Unstandard asymptotic 97.5% confidence interval; LL = lower limit, UL = upper limit *Superiority criterion: LL of the 97.5% CI for the difference in SCR > 15% Primary Efficacy Results: SCR for HI antibodies against A/turkey/Turkey/1/05 at 10 days after the first dose of A/turkey/Turkey/1/05 vaccine (ATP cohort for immunogenicity) Seroconversion rate 95% CI N n % LL UL Flu2-Flu1-F1-PBS, Day Flu2-Flu1-F2-PBS, Day Flu1-F3, Day 559* Flu1-F1, Day 559* Flu1-F4, Day 559* Flu1-F2, Day 559* PBS-Flu1-Flu1-F3, Day 192* Seroconversion rate defined as: For initially seronegative subjects, antibody titer 1:40 at Day 192 or Day 559 For initially seropositive subjects: antibody titer at Day 192 or Day fold the pre-vaccination antibody titer Seronegative subjects (antibody titer < 1:10 for A/turkey/Turkey/1/05) prior to vaccination Seropositive subjects (antibody titer 1:10 for A/turkey/Turkey/1/05) prior to vaccination N = number of subjects with both pre- and post-vaccination results available n/% = number/percentage of responders 95% CI = exact 95% confidence interval, LL = Lower Limit, UL = Upper Limit *Primary outcome variable Primary Efficacy Results: Adjusted ratios of post-vaccination GMTs for HI against A/turkey/Turkey/1/05 antibodies in Flu2- PBS-Flu1-F3 to PBS-Flu1-Flu1-F3 (control) at 10 days after the first A/turkey/Turkey/1/05 vaccine administration (ATP cohort for immunogenicity) Adjusted GMT ratio (Flu1-F3 / PBS-Flu1- Flu1-F3 ) Flu1-F3 PBS-Flu1-Flu1-F3 97.5% CI N Adjusted GMT N Adjusted GMT Value LL* UL Adjusted GMT = Geometric mean antibody titer adjusted for Age (Y), baseline titer N = Number of subjects with both pre- and post-vaccination results available 97.5% CI = 97.5% confidence interval for the adjusted GMT ratio; LL = lower limit, UL = upper limit *Superiority criterion: LL of 97.5% CI for the GMT ratio > 2.0 Primary Efficacy Results: Adjusted ratios of post-vaccination GMTs for HI against A/turkey/Turkey/1/05 antibodies in Flu2- PBS-Flu1-F4 to PBS-Flu1-Flu1-F3 (control) at 10 days after the first A/turkey/Turkey/1/05 vaccine administration (ATP cohort for immunogenicity) Adjusted GMT ratio (Flu1-F4 / PBS-Flu1- Flu1-F3 ) Flu1-F4 PBS-Flu1-Flu1-F3 97.5% CI N Adjusted GMT N Adjusted GMT Value LL* UL Adjusted GMT = Geometric mean antibody titer adjusted for Age (Y), baseline titer N = Number of subjects with both pre- and post-vaccination results available 97.5% CI = 97.5% confidence interval for the adjusted GMT ratio; LL = lower limit, UL = upper limit *Superiority criterion: LL of 97.5% CI for the GMT ratio > 2.0 Primary Efficacy Results: Adjusted ratios of post-vaccination GMTs for HI against A/turkey/Turkey/1/05 antibodies in Flu2- PBS-Flu1-F1 to PBS-Flu1-Flu1-F3 (control) at 10 days after the first A/turkey/Turkey/1/05 vaccine administration (ATP cohort for immunogenicity) Adjusted GMT ratio (Flu1-F1 / PBS-Flu1- Flu1-F3 ) Flu1-F1 PBS-Flu1-Flu1-F3 97.5% CI

6 N Adjusted GMT N Adjusted GMT Value LL* UL Adjusted GMT = Geometric mean antibody titer adjusted for Age (Y), baseline titer N = Number of subjects with both pre- and post-vaccination results available 97.5% CI = 97.5% confidence interval for the adjusted GMT ratio; LL = lower limit, UL = upper limit *Superiority criterion: LL of 97.5% CI for the GMT ratio > 2.0 Primary Efficacy Results: Adjusted ratios of post-vaccination GMTs for HI against A/turkey/Turkey/1/05 antibodies in Flu2- PBS-Flu1-F2 to PBS-Flu1-Flu1-F3 (control) at 10 days after the first A/turkey/Turkey/1/05 vaccine administration (ATP cohort for immunogenicity) Adjusted GMT ratio (Flu1-F2 / PBS-Flu1- Flu1-F3 ) Flu1-F2 PBS-Flu1-Flu1-F3 97.5% CI N Adjusted GMT N Adjusted GMT Value LL* UL Adjusted GMT = Geometric mean antibody titer adjusted for Age (Y), baseline titer N = Number of subjects with both pre- and post-vaccination results available 97.5% CI = 97.5% confidence interval for the adjusted GMT ratio; LL = lower limit, UL = upper limit *Superiority criterion: LL of 97.5% CI for the GMT ratio > 2.0 Primary Efficacy Results: GMT and SPRs for HI antibodies against A/turkey/Turkey/1/05 and A/Indonesia/5/05 at Day 0 through Day 591 (ATP cohort for immunogenicity) 1:40 GMT 95% CI 95% CI Antibody Timing N n % LL UL value LL UL A/turkey/Turkey/ Flu2-Flu1-F1-1/05 PBS Flu2-Flu1-F2- PBS Flu1-F3 Flu1-F1 Flu1-F4 PRE PI(D10) PI(D42) PI(D182) PII(D192) PII(D224) PII(D549) PIII(D591) PRE PI(D10) PI(D42) PI(D182) PII(D192) PII(D224) PII(D549) PIII(D591) PRE PI(D10) PI(D42) PI(D182) PII(D549) PIII(D559)* PIII(D591) PRE PI(D10) PI(D42) PI(D182) PII(D549) PIII(D559)* PIII(D591) PRE PI(D10)

7 A/Indonesia/5/0 5 Flu1-F2 PBS-Flu1- Flu1-F3 Flu2-Flu1-F1- PBS Flu2-Flu1-F2- PBS Flu1-F3 Flu1-F1 Flu1-F4 Flu1-F2 PBS-Flu1- Flu1-F3 PI(D42) PI(D182) PII(D549) PIII(D559)* PIII(D591) PRE PI(D10) PI(D42) PI(D182) PII(D549) PIII(D559)* PIII(D591) PRE PI(D10) PI(D182) PII(D192)* PII(D224) PII(D549) PIII(D559) PIII(D591) PRE PI(D10) PI(D42) PI(D182) PII(D192) PII(D224) PRE PI(D10) PI(D42) PI(D182) PII(D192) PII(D224) PRE PI(D10) PI(D42) PI(D182) PIII(D591) PRE PI(D10) PI(D42) PI(D182) PIII(D591) PRE PI(D10) PI(D42) PI(D182) PIII(D591) PRE PI(D10) PI(D42) PI(D182) PIII(D591) PRE PI(D10)

8 PI(D42) PI(D182) PII(D192) PII(D224) PIII(D591) SPR = A/turkey/Turkey/1/05 and A/Indonesia/5/05 antibody titers 1:40 GMT = geometric mean antibody titer calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with titer within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit *Primary outcome variable Primary Efficacy Results: Number (%) of solicited local symptoms during the 7-day (Days 0-6) post-vaccination period following each dose and across doses (Total Vaccinated cohort) Flu2-Flu1-F1-PBS Flu2-Flu1-F2-PBS Flu1-F3 95 % CI 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL N n % LL UL Dose 1 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Dose 2 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Dose 3 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Across doses Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Flu1-F1 Flu1-F4 Flu1-F2 95 % CI 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL N n % LL UL Dose 1 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm

9 Dose 2 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Dose 3 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Across doses Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm PBS-Flu1-Flu1-F3 95 % CI Symptom Intensity N n % LL UL Dose 1 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Dose 2 Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm Dose 3 Pain Any Grade Redness Any > 100 mm Swelling (mm) Any > 100 mm Across doses Pain Any Grade Redness Any > 100 mm Swelling Any > 100 mm N= Number of subjects with at least one administered dose n/%= Number/percentage of subjects reporting at least once the symptom

10 95% CI= Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = occurrence of local symptom regardless of the intensity grade Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school Primary Efficacy Results: Number (%) of solicited general symptoms reported during the 7-day (Days 0-6) post-vaccination period following each dose and across doses (Total Vaccinated cohort) Flu2-Flu1-F1-PBS Flu2-Flu1-F2-PBS Flu1-F3 95 % CI 95 % CI 95 % CI Symptom Intensity/ Relationship N n % LL UL N n % LL UL N n % LL UL Dose 1 Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Orally) 38.0 C C Related Dose 2 Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Orally) 38.0 C C Related Dose 3

11 Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Orally) 38.0 C C Related Across doses Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Orally) Symptom 38.0 C C Related Flu1-F1 Flu1-F4 Flu1-F2 95 % CI 95 % CI 95 % CI Intensity/R elationship N n % LL UL N n % LL UL N n % LL UL Dose 1 Fatigue Any Grade Related Headache Any Grade Related

12 Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Orally) 38.0 C C Related Dose 2 Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Orally) 38.0 C C Related Dose 3 Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any

13 Temperature/ (Orally) Grade Related C C Related Across doses Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Orally) 38.0 C C Related PBS-Flu1-Flu1-F3 95 % CI Symptom Intensity/Relationship N n % LL UL Dose 1 Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/(Orally) 38.0 C C Related Dose 2 Fatigue Any

14 Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/(Orally) 38.0 C C Related Dose 3 Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/(Orally) 38.0 C C Related Across doses Fatigue Any Grade Related Headache Any Grade Related Joint pain at other location Any Grade Related Muscle aches Any Grade

15 Related Shivering Any Grade Related Sweating Any Grade Related Temperature/(Orally) 38.0 C C Related N= Number of subjects with at least one administered dose n/%= Number/percentage of subjects reporting at least once the symptom 95% CI= Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = occurrence of general symptom regardless of intensity grade or relationship to vaccination Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider Related = general symptom assessed by the investigator as causally related to the vaccination Primary Efficacy Results: Number (%) of subjects reporting the occurrence of MAEs occurring during the entire study period (Days 0-909) (Total Vaccinated Cohort) MAEs Flu2-Flu1- F1-PBS N = 120 Flu2-Flu1- F2-PBS N = 121 Flu1-F3 N = 119 Flu1-F1 N = 119 Flu1-F4 N = 122 Flu1-F2 N = 120 PBS-Flu1- Flu1-F3 N = 120 Subjects with any MAE(s), n (%) 68 (56.7) 66 (54.5) 77 (64.7) 75 (63.0) 62 (50.8) 63 (52.5) 70 (58.3) Sinusitis 7 (5.8) 8 (6.6) 10 (8.4) 9 (7.6) 4 (3.3) 5 (4.2) 12 (10.0) Bronchitis 5 (4.2) 7 (5.8) 4 (3.4) 8 (6.7) 5 (4.1) 6 (5.0) - Upper respiratory tract infection 4 (3.3) 4 (3.3) 5 (4.2) 3 (2.5) Hypertension (4.1) 4 (3.3) 4 (3.3) Lymphadenopathy 5 (4.2) 4 (3.3) (2.5) - - Urinary tract infection (2.5) - 4 (3.3) 4 (3.3) Cystitis 5 (4.2) - 5 (4.2) Back pain (2.5) - 6 (5.0) - Cough (2.5) 6 (4.9) - - Pneumonia 4 (3.3) 4 (3.3) Arthralgia 4 (3.3) Asthma (3.4) Depression (3.3) Ear infection (3.3) Muscle strain (3.4) Musculoskeletal pain (3.4) Procedural pain (3.3) Cataract (2.5) - - Contusion (2.5) - - Eye infection (2.5) - - Influenza like illness (2.5) Joint sprain (2.5) - - Nasopharyngitis (2.5) - - Nausea (2.5) - - Pharyngitis streptococcal (2.5) Counting rule applied: As there were more than 30 subjects per treatment group and > 3 groups, only the 5 most frequent events in each treatment group are to be listed. -: Implies that adverse event was not reported in the particular group or that the adverse event was reported in the particular group but did not fall within the pre-defined counting rule of 5 most frequent events for that group. Primary Efficacy Results: Please refer to the safety section of this document for the results on unsolicited AEs and SAEs. Secondary Outcome Variable(s): GMT and SPR for HI antibodies against A/turkey/Turkey/5/05, A/Indonesia/5/05, and A/Vietnam/1194/04 at Days 0, 182, 192, 224, 549, 559, 591 and 729 (ATP cohort for immunogenicity at Day 729)

16 1:40 GMT 95% CI 95% CI Antibody Timing N n % LL UL Value LL UL A/turkey/ Turkey/5/05 Flu2-Flu1-F1- PBS Flu2-Flu1-F2- PBS Flu1- F3 Flu1- F1 Flu1- F4 Flu1- F2 PBS-Flu1-Flu1- F3 PRE PI(D10) PI(D42) PI(D182) PII(D192) PII(D224) PII(D549) PIII(D591) PIII(D729) PRE PI(D10) PI(D42) PI(D182) PII(D192) PII(D224) PII(D549) PIII(D591) PIII(D729) PRE PI(D10) PI(D42) PI(D182) PII(D549) PIII(D559) PIII(D591) PIII(D729) PRE PI(D10) PI(D42) PI(D182) PII(D549) PIII(D559) PIII(D591) PIII(D729) PRE PI(D10) PI(D42) PI(D182) PII(D549) PIII(D559) PIII(D591) PIII(D729) PRE PI(D10) PI(D42) PI(D182) PII(D549) PIII(D559) PIII(D591) PIII(D729) PRE PI(D10)