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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. GSK Medicine: GSK3003891A, GSK3003892A, GSK3003893A, GSK3003896A, GSK3003898A, GSK3003899A Study Number: 116969 (RSV F-001) Title: An observer-blind study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals Respiratory Syncytial Virus (RSV) investigational vaccine (GSK3003891A) in healthy men. GSK3003891A (RSV): GlaxoSmithKline (GSK) Biologicals RSV investigational vaccine. Rationale: The purpose of this first-time-in-humans study was to evaluate the safety and immunogenicity of 6 investigational RSV vaccine formulations, when administered as a single intramuscular dose to healthy men aged 18 to 44 years. 3 different concentrations of the active compound were evaluated: low-dose (LD), medium-dose (MD) and -high-dose (HD); each one administered either non-adjuvanted or adjuvanted with aluminium. A placebo was used as control. The subjects were followed-up for approximately 1 year after vaccination, starting from Day 0 up to, and including, Day 360. This summary presents results up to the Day 60 time point (primary completion date). When the results collected beyond the Day 60 time point are available, this summary will be updated. GSK3003892A (RSV-LD): GSK Biologicals RSV vaccine, in a LD formulation, non-adjuvanted. GSK3003893A (RSV-LD alum): GSK Biologicals RSV vaccine, LD formulation, aluminium-adjuvanted. GSK3003895A (RSV-MD): GSK Biologicals RSV vaccine, MD formulation, non-adjuvanted. GSK3003896A (RSV-MD alum): GSK Biologicals RSV vaccine, MD formulation, aluminium-adjuvanted. GSK3003898A (RSV-HD): GSK Biologicals RSV vaccine, HD formulation, non-adjuvanted. GSK3003899A (RSV-HD alum): GSK Biologicals RSV vaccine, HD formulation, aluminium-adjuvanted. Phase: I Study Period: 22 July 2013 to 9 April 2014 (Day 60 time point,) Study Design: Randomized, observer-blind, single-country, placebo-controlled, dose-escalation* study with 2 steps and 8 groups; 5 in Step 1 (randomization ratio 1:1:1:1:1) and 3 in Step 2 (randomization ratio 1:1:1) *Refer to the Treatment Section below for details on dose-escalation procedures in this study. Centres: 3 centers in Canada Indication: Administration of RSV investigational vaccine in healthy men aged 18 to 44 years Treatment: Study groups were as follows: RSV-LD (Step 1): Subjects received one dose of non-adjuvanted RSV-LD vaccine. RSV-LD alum (Step 1): Subjects received one dose of aluminium-adjuvanted RSV-LD vaccine. RSV-MD (Step 1): Subjects received one dose of non-adjuvanted RSV-MD vaccine. RSV-MD alum (Step 1): Subjects received one dose of aluminium-adjuvanted RSV-MD vaccine. RSV-HD (Step 2): Subjects received one dose of non-adjuvanted RSV-HD vaccine. RSV-HD alum (Step 2): Subjects received one dose of aluminium-adjuvanted RSV-HD vaccine. Control-1 (Step 1): Subjects received one dose of placebo solution. Conrol-2 (Step 2): Subjects received one dose of placebo solution. The RSV vaccine and placebo solution were administered intramuscularly in the deltoid. Enrolment in this study was conducted in a staggered manner, including 2 steps. During Step 1, the LD and MD formulations of the RSV vaccine, non-adjuvanted or adjuvanted with alum, were evaluated. Thereafter, during Step 2, the HD formulations of the RSV vaccine, non-adjuvanted or adjuvanted with alum, were evaluated. Enrolment for this Step 2 was conditional on the favorable outcome of the evaluation of safety data collected from subjects enrolled in Step 1, up to 7 days after vaccination. The safety evaluation was performed by an Internal Safety Review Committee Objectives: To evaluate the safety and tolerability of a single intramuscular dose of the RSV investigational vaccines, up to 60 days after vaccination. Primary Outcome Variable: Occurrence of adverse events (AEs) from vaccination to Day 60, in all subjects, in all groups: o Occurrence of each solicited local and general AE, during a 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days). o Occurrence of any hematological (hemoglobin level, white blood cell [WBC], lymphocyte, neutrophil, eosinophil

and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality at Day 0, Day 7, Day 30 and Day 60. Occurrence of any unsolicited AE, during a 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days). Occurrence of any Serious Adverse Events (SAEs) from Day 0 to Day 60. Secondary Outcome Variable(s): Humoral immune response to the investigational RSV vaccines, pre-vaccination (Day 0) and post-vaccination (Day 7, Day 30 and Day 60), in all subjects, in all groups: Neutralizing antibody titers against RSV subgroup A. Neutralizing antibody titers against RSV subgroup B. Enzyme-linked Immunosorbent Assay (ELISA) antibody titers against RSV. Occurrence of AEs, in all subjects, in all groups*: Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality at Day 180 and Day 360. Occurrence of any SAE from Day 60 to the study conclusion. Persistence of the humoral immune response to the investigational RSV vaccines, at Day 180 and Day 360, in all subjects, in all groups*: Neutralizing antibody titers against RSV subgroup A. Neutralizing antibody titers against RSV subgroup B. ELISA antibody titers against RSV. * This summary presents results up to the Day 60 time point. When the results collected beyond the Day 60 time point are available, this summary will be updated. Statistical Methods: The analysis was performed on the Total Vaccinated cohort and on the According-to-Protocol (ATP) cohort for immunogenicity: - The Total Vaccinated cohort included all subjects with study vaccine administration documented. - The ATP cohort for immunogenicity included all subjects, included in the Total Vaccinated cohort meeting all eligibility criteria and for whom the administration route and site of the vaccine was according the protocol, who did not have received a vaccine not specified or forbidden in the protocol up to Day 30 visit and who, up to the Day 60 visit, did not receive a concomitant medication/ product or present with a medical condition leading to exclusion from the ATP analysis and who complied with the protocol-specified timing of the 30 days and 60 days post-vaccination blood sample and for whom post-vaccination immunogenicity results were available for at least 1 anti-rsv assay for at least one time point. Analysis of Safety The analysis was performed on Total Vaccinated cohort. The percentage of subjects with solicited local and general symptoms during the 7-day follow-up period after vaccination was tabulated for each group with exact 95% confidence interval (CI). The same tabulation was performed for Grade 3 solicited local and general symptoms and for solicited general symptoms assessed by the investigator as related to the study vaccination. For each group and for each hematology and biochemistry parameter, the percentage of subjects having hematology and biochemistry results below or above the local laboratory normal ranges with reference to baseline was tabulated by time point. The percentage of subjects reporting the occurrence of unsolicited AE during the 30-day follow-up period after vaccination was classified by Medical Dictionary for Regulatory Activities (MedDRA) preferred term and tabulated by group. The percentages of subjects with SAEs as well as the number of subjects with SAEs assessed by the investigator as related to study vaccination, from study start up to Day 60 were to be classified by MedDRA preferred term and tabulated by group. Analysis of Immunogenicity The analysis was performed on the ATP cohort for immunogenicity. For the anti-rsv humoral immune response, for each group, at each time point that blood samples were collected for the anti- RSV-A and anti-rsv-b neutralization assay (cut-off = 8 and 6 ED60 respectively) and for the anti-rsv ELISA assay (cut-off = 5 EU/mL), the following was performed: -The percentage of subjects above the cut-off and their exact 95% CI was tabulated. -Geometric mean concentrations/titers (GMCs/GMTs) and their 95% CI were calculated. Study Population: Healthy males between, and including, 18 and 44 years of age at the time of vaccination were enrolled in the study. Subjects were excluded from the study if they had had previous vaccination against RSV, any confirmed or suspected immunosuppressive or immunodeficient condition, a family history of congenital or hereditary immunodeficiency, history of or current autoimmune disease, history of any reaction or hypersensitivity likely to be exacerbated by any

component of the vaccines, any clinically significant hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) abnormality, as per the opinion of the investigator based on the local laboratory normal ranges. Subjects with a minor illness (such as mild diarrhea) without fever could be enrolled at the discretion of the investigator. Written informed consent was obtained from subjects prior to any stud procedure. Number of Subjects: RSV-LD RSV-LD RSV-MD RSV-MD RSV-HD RSV-HD Control Control alum alum alum 1 2 Planned, N 16 16 16 16 16 16 16 16 Randomized, N (Total Vaccinated cohort) 16 16 15 16 16 16 17 16 Completed to Day 60, n (%) 16 (100) 15 (93.8) 15 (100) 15 (93.8) 16 (100) 16 (100) 17 (100) 16 (100) Number of subjects withdrawn, N (%) 0 (0.0) 1 (6.2) 0 (0.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Withdrawn due to Adverse Events n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Withdrawn due to Lack of Efficacy n (%) Not applicable Withdrawn for other reasons n (%) 0 (0.0) 1 (6.2) 0 (0.0) 1 (6.2) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Demographics RSV-LD RSV-LD RSV-MD RSV-MD RSV-HD RSV-HD Control Control alum alum alum 1 2 N (Total Vaccinated cohort) 16 16 15 16 16 16 17 16 Males, n (%) 16 (100) 16 (100) 15 (100) 16 (100) 16 (100) 16 (100) 17 (100) 16 (100) Mean Age, years (SD) 32.1 (7.80) 32.1 (7.39) 33.7 (6.56) 32.3 (7.22) 31.1 (7.92) 32.8 (6.18) 29.3 (8.04) 30.8 (7.55) Median 32 33 32 32 31 31 28 33 Minimum, Maximum 20, 43 20, 41 21, 43 22, 44 20, 43 21, 42 18, 43 20, 44 White - Caucasian / European Heritage, n (%) 11(68.8) 11 (68.8) 13 (86.7) 10 (62.5) 6 (37.5) 7 (43.8) 12 (70.6) 8 (50.0) Asian - South East Asian Heritage, n (%) 3 (18.8) 1 (6.3) 2 (13.3) 2 (12.5) 5 (31.3) 8 (50.0) 2 (11.8) 6 (37.5) African Heritage / African American, n (%) 1 (6.3) 2 (12.5) 0 (0.0) 2 (12.5) 4 (25.0) 1 (6.3) 0 (0.0) 1 (6.3) Primary Outcome Results: Incidence of solicited local symptoms reported during the 7-day (Days 0-6) post-vaccination period (Total Vaccinated cohort) RSV-LD RSV-LD alum RSV-MD RSV-MD alum 95 % CI 95 % CI 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL N n % LL UL N n % LL UL Pain Any 16 2 12.5 1.6 38.3 16 7 43.8 19.8 70.1 15 4 26.7 7.8 55.1 16 13 81.3 54.4 96.0 Grade 3 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 Redness Any 16 1 6.3 0.2 30.2 16 0 0.0 0.0 20.6 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 >100 mm 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 Swelling Any 16 0 0.0 0.0 20.6 16 1 6.3 0.2 30.2 15 1 6.7 0.2 31.9 16 0 0.0 0.0 20.6 >100 mm 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 RSV-HD RSV-HD alum Control 1 Control 2 95 % CI 95 % CI 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL N n % LL UL N n % LL UL Pain Any 16 10 62.5 35.4 84.8 16 9 56.3 29.9 80.2 17 1 5.9 0.1 28.7 16 2 12.5 1.6 38.3 Grade 3 16 0 0.0 0.0 20.6 16 1 6.3 0.2 30.2 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 Redness Any 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 >100 mm 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 Swelling Any 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 >100 mm 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 N = number of subjects with the documented dose n/% = number/percentage of subjects reporting the symptom at least once 95%CI = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = incidence of a particular symptom regardless of grade. Grade 3 pain = significant pain at rest. Symptom which prevented normal everyday activities

Primary Outcome Results: Incidence of solicited general symptoms reported during the 7-day (Days 0-6) post-vaccination period (Total Vaccinated cohort) RSV-LD RSV-LD alum RSV-MD RSV-MD alum 95 % CI 95 % CI 95 % CI 95 % CI Symptom Intensity /Relatio nship N n % LL UL N n % LL UL N n % LL UL N n % LL UL Fatigue Any 16 3 18.8 4.0 45.6 16 7 43.8 19.8 70.1 15 5 33.3 11.8 61.6 16 3 18.8 4.0 45.6 Grade 3 16 1 6.3 0.2 30.2 16 2 12.5 1.6 38.3 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 Related 16 2 12.5 1.6 38.3 16 4 25.0 7.3 52.4 15 4 26.7 7.8 55.1 16 1 6.3 0.2 30.2 Gastrointestinal symptoms Any 16 3 18.8 4.0 45.6 16 1 6.3 0.2 30.2 15 2 13.3 1.7 40.5 16 0 0.0 0.0 20.6 Grade 3 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 Related 16 2 12.5 1.6 38.3 16 1 6.3 0.2 30.2 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 Headache Any 16 2 12.5 1.6 38.3 16 4 25.0 7.3 52.4 15 2 13.3 1.7 40.5 16 3 18.8 4.0 45.6 Grade 3 16 0 0.0 0.0 20.6 16 2 12.5 1.6 38.3 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 Related 16 1 6.3 0.2 30.2 16 1 6.3 0.2 30.2 15 2 13.3 1.7 40.5 16 1 6.3 0.2 30.2 Temperature (Oral) Symptom 37.5 C 16 2 12.5 1.6 38.3 16 2 12.5 1.6 38.3 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 >39.5 C 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 Related 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 15 0 0.0 0.0 21.8 16 0 0.0 0.0 20.6 RSV-HD RSV-HD alum Control 1 Control 2 95 % CI 95 % CI 95 % CI 95 % CI Intensity Relation ship N n % LL UL N n % LL UL N n % LL UL N n % LL UL Fatigue Any 16 7 43.8 19.8 70.1 16 3 18.8 4.0 45.6 17 2 11.8 1.5 36.4 16 4 25.0 7.3 52.4 Grade 3 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 Related 16 4 25.0 7.3 52.4 16 2 12.5 1.6 38.3 17 1 5.9 0.1 28.7 16 2 12.5 1.6 38.3 Gastrointestina l symptoms Any 16 3 18.8 4.0 45.6 16 2 12.5 1.6 38.3 17 2 11.8 1.5 36.4 16 4 25.0 7.3 52.4 Grade 3 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 1 6.3 0.2 30.2 Related 16 3 18.8 4.0 45.6 16 0 0.0 0.0 20.6 17 1 5.9 0.1 28.7 16 2 12.5 1.6 38.3 Headache Any 16 7 43.8 19.8 70.1 16 3 18.8 4.0 45.6 17 2 11.8 1.5 36.4 16 6 37.5 15.2 64.6 Grade 3 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 Related 16 4 25.0 7.3 52.4 16 2 12.5 1.6 38.3 17 1 5.9 0.1 28.7 16 4 25.0 7.3 52.4 Temperature (Oral) 37.5 C 16 2 12.5 1.6 38.3 16 2 12.5 1.6 38.3 17 1 5.9 0.1 28.7 16 0 0.0 0.0 20.6 >39.5 C 16 0 0.0 0.0 20.6 16 0 0.0 0.0 20.6 17 0 0.0 0.0 19.5 16 0 0.0 0.0 20.6 Related 16 1 6.3 0.2 30.2 16 2 12.5 1.6 38.3 17 1 5.9 0.1 28.7 16 0 0.0 0.0 20.6 N = number of subjects with the documented dose n/% = number/percentage of subjects reporting the symptom at least once 95%CI = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = incidence of a particular symptom regardless of grade or relationship to vaccination Grade 3 = symptom which prevented normal everyday activities Related = symptom assessed by the investigator(s) to be causally related to study vaccination. Primary Outcome Results: Distribution of change from baseline in hematology and biochemistry parameters up to Day 60 with respect to normal laboratory ranges (Total Vaccinated cohort) RSV-LD RSV-LD alum Unknown Below Within Above Unknown Below Within Above N n % n % n % n % N n % n % n % n % Laboratory parameter Baseline Timing (PRE) ALT PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 13 0 0.0 0 0.0 12 92.3 1 7.7 14 0 0.0 0 0.0 12 85.7 2 14.3 Above 3 0 0.0 0 0.0 1 33.3 2 66.7 2 0 0.0 0 0.0 0 0.0 2 100 Within 13 0 0.0 0 0.0 13 100 0 0.0 14 0 0.0 0 0.0 12 85.7 2 14.3 Above 3 0 0.0 0 0.0 0 0.0 3 100 2 0 0.0 0 0.0 1 50.0 1 50.0

Within 13 0 0.0 0 0.0 12 92.3 1 7.7 13 0 0.0 0 0.0 10 76.9 3 23.1 Above 3 0 0.0 0 0.0 1 33.3 2 66.7 2 0 0.0 0 0.0 0 0.0 2 100 AST PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 1 0 0.0 0 0.0 0 0.0 1 100 1 0 0.0 0 0.0 0 0.0 1 100 Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 1 0 0.0 0 0.0 0 0.0 1 100 1 0 0.0 0 0.0 1 100 0 0.0 Creatinine PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 0 - - - - - - - - 2 0 0.0 0 0.0 2 100 0 0.0 Within 16 0 0.0 1 6.3 14 87.5 1 6.3 13 0 0.0 0 0.0 12 92.3 1 7.7 Above 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Below 0 - - - - - - - - 2 0 0.0 2 100 0 0.0 0 0.0 Within 16 0 0.0 0 0.0 16 100 0 0.0 13 0 0.0 0 0.0 12 92.3 1 7.7 Above 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Below 0 - - - - - - - - 2 0 0.0 2 100 0 0.0 0 0.0 Within 16 0 0.0 1 6.3 15 93.8 0 0.0 12 0 0.0 0 0.0 12 100 0 0.0 Above 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Eosinophils PI(D7) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 0 - - - - - - - - 1 0 0.0 0 0.0 0 0.0 1 100 PI(D30) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 0 - - - - - - - - 1 0 0.0 0 0.0 0 0.0 1 100 PI(D60) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 1 0 0.0 0 0.0 0 0.0 1 100 Hemoglobin PI(D7) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 14 0 0.0 0 0.0 13 92.9 1 7.1 Above 0 - - - - - - - - 2 0 0.0 0 0.0 2 100 0 0.0 PI(D30) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 1 50.0 1 50.0 PI(D60) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 14 93.3 1 6.7 13 0 0.0 0 0.0 11 84.6 2 15.4 Above 0 - - - - - - - - 2 0 0.0 0 0.0 1 50.0 1 50.0 WBC PI(D7) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 16 0 0.0 0 0.0 16 100 0 0.0

PI(D30) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 14 93.3 1 6.7 16 0 0.0 0 0.0 16 100 0 0.0 PI(D60) Unknown 1 0 0.0 1 100 0 0.0 0 0.0 0 - - - - - - - - Within 15 0 0.0 1 6.7 13 86.7 1 6.7 15 0 0.0 0 0.0 14 93.3 1 6.7 Lymphocytes PI(D7) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 3 0 0.0 0 0.0 3 100 0 0.0 3 0 0.0 3 100 0 0.0 0 0.0 Within 12 0 0.0 0 0.0 12 100 0 0.0 13 0 0.0 0 0.0 13 100 0 0.0 PI(D30) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 3 0 0.0 1 33.3 2 66.7 0 0.0 3 0 0.0 2 66.7 1 33.3 0 0.0 Within 12 0 0.0 0 0.0 12 100 0 0.0 13 0 0.0 0 0.0 12 92.3 1 7.7 PI(D60) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 3 0 0.0 1 33.3 2 66.7 0 0.0 3 0 0.0 2 66.7 1 33.3 0 0.0 Within 12 0 0.0 0 0.0 12 100 0 0.0 12 0 0.0 0 0.0 12 100 0 0.0 Neutrophils PI(D7) Unknown 1 0 0.0 0 0.0 0 0.0 1 100 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 1 0 0.0 1 100 0 0.0 0 0.0 Within 14 0 0.0 0 0.0 14 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 PI(D30) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 Within 14 0 0.0 0 0.0 13 92.9 1 7.1 15 0 0.0 1 6.7 14 93.3 0 0.0 PI(D60) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 1 100 0 0.0 0 0.0 Within 14 0 0.0 0 0.0 13 92.9 1 7.1 14 0 0.0 0 0.0 13 92.9 1 7.1 Platelets PI(D7) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 2 0 0.0 1 50.0 1 50.0 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 Within 13 0 0.0 0 0.0 13 100 0 0.0 15 0 0.0 1 6.7 13 86.7 1 6.7 PI(D30) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 2 0 0.0 2 100 0 0.0 0 0.0 1 0 0.0 1 100 0 0.0 0 0.0 Within 13 0 0.0 0 0.0 13 100 0 0.0 15 0 0.0 1 6.7 14 93.3 0 0.0 PI(D60) Unknown 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 2 0 0.0 1 50.0 1 50.0 0 0.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 13 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 RSV-MD RSV-MD alum Unknown Below Within Above Unknown Below Within Above Laboratory parameter Baseline Timing (PRE) N n % n % n % n % N n % n % n % n % ALT PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 9 0 0.0 0 0.0 7 77.8 2 22.2 13 0 0.0 0 0.0 13 100 0 0.0 Above 6 0 0.0 0 0.0 0 0.0 6 100 3 0 0.0 0 0.0 1 33.3 2 66.7 Within 9 0 0.0 0 0.0 7 77.8 2 22.2 12 0 0.0 0 0.0 12 100 0 0.0 Above 6 0 0.0 0 0.0 1 16.7 5 83.3 3 0 0.0 0 0.0 1 33.3 2 66.7

Within 9 0 0.0 0 0.0 8 88.9 1 11.1 12 0 0.0 0 0.0 12 100 0 0.0 Above 6 0 0.0 0 0.0 1 16.7 5 83.3 3 0 0.0 0 0.0 1 33.3 2 66.7 AST PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 13 0 0.0 0 0.0 12 92.3 1 7.7 16 0 0.0 0 0.0 16 100 0 0.0 Above 2 0 0.0 0 0.0 1 50.0 1 50.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 12 92.3 1 7.7 15 0 0.0 0 0.0 15 100 0 0.0 Above 2 0 0.0 0 0.0 2 100 0 0.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 12 92.3 1 7.7 15 0 0.0 0 0.0 15 100 0 0.0 Above 2 0 0.0 0 0.0 2 100 0 0.0 0 - - - - - - - - Creatinine PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 15 0 0.0 1 6.7 14 93.3 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 1 50.0 1 50.0 Within 15 0 0.0 1 6.7 12 80.0 2 13.3 13 0 0.0 0 0.0 13 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 0 0.0 2 100 Within 15 0 0.0 0 0.0 15 100 0 0.0 13 0 0.0 0 0.0 13 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 0 0.0 2 100 Eosinophils PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 13 0 0.0 0 0.0 11 84.6 2 15.4 Above 0 - - - - - - - - 3 0 0.0 0 0.0 0 0.0 3 100 Within 15 0 0.0 0 0.0 15 100 0 0.0 12 0 0.0 0 0.0 11 91.7 1 8.3 Above 0 - - - - - - - - 3 0 0.0 0 0.0 0 0.0 3 100 Within 15 0 0.0 0 0.0 13 86.7 2 13.3 12 0 0.0 0 0.0 11 91.7 1 8.3 Above 0 - - - - - - - - 3 0 0.0 0 0.0 0 0.0 3 100 Hemoglobin PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 12 0 0.0 0 0.0 11 91.7 1 8.3 12 0 0.0 0 0.0 12 100 0 0.0 Above 3 0 0.0 0 0.0 2 66.7 1 33.3 4 0 0.0 0 0.0 2 50.0 2 50.0 Within 12 0 0.0 0 0.0 12 100 0 0.0 11 0 0.0 0 0.0 11 100 0 0.0 Above 3 0 0.0 0 0.0 2 66.7 1 33.3 4 0 0.0 0 0.0 1 25.0 3 75.0 Within 12 0 0.0 0 0.0 10 83.3 2 16.7 11 0 0.0 0 0.0 11 100 0 0.0 Above 3 0 0.0 0 0.0 2 66.7 1 33.3 4 0 0.0 0 0.0 1 25.0 3 75.0 WBC PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 3 0 0.0 1 33.3 2 66.7 0 0.0 Within 14 0 0.0 0 0.0 14 100 0 0.0 13 0 0.0 1 7.7 12 92.3 0 0.0

Below 1 0 0.0 1 100 0 0.0 0 0.0 2 0 0.0 2 100 0 0.0 0 0.0 Within 14 0 0.0 0 0.0 13 92.9 1 7.1 13 0 0.0 0 0.0 13 100 0 0.0 Below 1 0 0.0 1 100 0 0.0 0 0.0 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 14 0 0.0 1 7.1 12 85.7 1 7.1 13 0 0.0 0 0.0 13 100 0 0.0 Lymphocytes PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 2 0 0.0 1 50.0 1 50.0 0 0.0 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 12 0 0.0 1 8.3 11 91.7 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Below 3 0 0.0 2 66.7 1 33.3 0 0.0 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 12 0 0.0 1 8.3 11 91.7 0 0.0 13 0 0.0 1 7.7 12 92.3 0 0.0 Below 3 0 0.0 2 66.7 1 33.3 0 0.0 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 12 0 0.0 0 0.0 12 100 0 0.0 13 0 0.0 0 0.0 13 100 0 0.0 Neutrophils PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 2 0 0.0 2 100 0 0.0 0 0.0 Within 13 0 0.0 0 0.0 13 100 0 0.0 14 0 0.0 2 14.3 12 85.7 0 0.0 Below 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 Within 14 0 0.0 0 0.0 14 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Below 1 0 0.0 1 100 0 0.0 0 0.0 1 0 0.0 1 100 0 0.0 0 0.0 Within 14 0 0.0 0 0.0 13 92.9 1 7.1 14 0 0.0 0 0.0 14 100 0 0.0 Platelets PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Below 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Within 15 0 0.0 1 6.7 14 93.3 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Below 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 RSV-HD RSV-HD alum Unknown Below Within Above Unknown Below Within Above Laboratory parameter Baseline Timing (PRE) N n % n % n % n % N n % n % n % n % ALT PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 13 0 0.0 0 0.0 12 92.3 1 7.7 13 0 0.0 0 0.0 13 100 0 0.0 Above 3 0 0.0 0 0.0 0 0.0 3 100 3 0 0.0 0 0.0 2 66.7 1 33.3 Within 13 0 0.0 0 0.0 13 100 0 0.0 13 0 0.0 0 0.0 13 100 0 0.0 Above 3 0 0.0 0 0.0 1 33.3 2 66.7 2 0 0.0 0 0.0 0 0.0 2 100

Within 13 0 0.0 0 0.0 13 100 0 0.0 13 0 0.0 0 0.0 12 92.3 1 7.7 Above 3 0 0.0 0 0.0 0 0.0 3 100 3 0 0.0 0 0.0 1 33.3 2 66.7 AST PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 14 0 0.0 0 0.0 13 92.9 1 7.1 16 0 0.0 0 0.0 16 100 0 0.0 Above 2 0 0.0 0 0.0 0 0.0 2 100 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 2 0 0.0 0 0.0 1 50.0 1 50.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 0 0.0 16 100 0 0.0 Above 2 0 0.0 0 0.0 0 0.0 2 100 0 - - - - - - - - Creatinine PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 16 0 0.0 0 0.0 16 100 0 0.0 16 0 0.0 1 6.3 15 93.8 0 0.0 Within 16 0 0.0 1 6.3 15 93.8 0 0.0 15 0 0.0 2 13.3 13 86.7 0 0.0 Within 16 0 0.0 0 0.0 16 100 0 0.0 16 0 0.0 2 12.5 13 81.3 1 6.3 Eosinophils PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 2 0 0.0 0 0.0 0 0.0 2 100 1 0 0.0 0 0.0 0 0.0 1 100 Within 14 0 0.0 0 0.0 14 100 0 0.0 15 0 0.0 0 0.0 14 93.3 1 6.7 Above 2 0 0.0 0 0.0 2 100 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 15 0 0.0 0 0.0 14 93.3 1 6.7 Above 2 0 0.0 0 0.0 2 100 0 0.0 1 0 0.0 0 0.0 0 0.0 1 100 Hemoglobin PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 2 0 0.0 2 100 0 0.0 0 0.0 Within 14 0 0.0 1 7.1 13 92.9 0 0.0 14 0 0.0 0 0.0 12 85.7 2 14.3 Above 1 0 0.0 0 0.0 0 0.0 1 100 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 2 0 0.0 2 100 0 0.0 0 0.0 Within 14 0 0.0 0 0.0 14 100 0 0.0 13 0 0.0 0 0.0 13 100 0 0.0 Above 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 14 0 0.0 0 0.0 14 100 0 0.0 14 0 0.0 0 0.0 13 92.9 1 7.1 Above 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - WBC PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 3 0 0.0 1 33.3 2 66.7 0 0.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 13 100 0 0.0 16 0 0.0 1 6.3 14 87.5 1 6.3

Below 3 0 0.0 2 66.7 1 33.3 0 0.0 0 - - - - - - - - Within 13 0 0.0 1 7.7 12 92.3 0 0.0 15 0 0.0 1 6.7 14 93.3 0 0.0 Below 3 0 0.0 2 66.7 1 33.3 0 0.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 13 100 0 0.0 16 0 0.0 1 6.3 14 87.5 1 6.3 Lymphocytes PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 0 - - - - - - - - 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 16 0 0.0 0 0.0 16 100 0 0.0 14 0 0.0 0 0.0 13 92.9 1 7.1 Below 0 - - - - - - - - 1 0 0.0 1 100 0 0.0 0 0.0 Within 16 0 0.0 1 6.3 15 93.8 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Below 0 - - - - - - - - 2 0 0.0 2 100 0 0.0 0 0.0 Within 16 0 0.0 1 6.3 15 93.8 0 0.0 14 0 0.0 1 7.1 13 92.9 0 0.0 Neutrophils PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Below 4 0 0.0 2 50.0 2 50.0 0 0.0 0 - - - - - - - - Within 12 0 0.0 0 0.0 12 100 0 0.0 16 0 0.0 0 0.0 16 100 0 0.0 Below 4 0 0.0 2 50.0 2 50.0 0 0.0 0 - - - - - - - - Within 12 0 0.0 0 0.0 12 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Below 4 0 0.0 2 50.0 2 50.0 0 0.0 0 - - - - - - - - Within 12 0 0.0 1 8.3 11 91.7 0 0.0 16 0 0.0 0 0.0 15 93.8 1 6.3 Platelets PI(D7) Unknown 0 - - - - - - - - 0 - - - - - - - - Within 16 0 0.0 1 6.3 15 93.8 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Within 16 0 0.0 0 0.0 16 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Within 16 0 0.0 1 6.3 15 93.8 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Above 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Control 1 Control 2 Unknown Below Within Above Unknown Below Within Above Laboratory parameter Baseline Timing (PRE) N n % n % n % n % N n % n % n % n % ALT PI(D7) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 12 92.3 1 7.7 12 0 0.0 0 0.0 12 100 0 0.0 Above 3 0 0.0 0 0.0 0 0.0 3 100 4 0 0.0 0 0.0 0 0.0 4 100 PI(D30) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 10 76.9 3 23.1 12 0 0.0 0 0.0 12 100 0 0.0 Above 3 0 0.0 0 0.0 1 33.3 2 66.7 4 0 0.0 0 0.0 1 25.0 3 75.0

PI(D60) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Within 13 0 0.0 0 0.0 11 84.6 2 15.4 12 0 0.0 0 0.0 12 100 0 0.0 Above 3 0 0.0 0 0.0 1 33.3 2 66.7 4 0 0.0 0 0.0 3 75.0 1 25.0 AST PI(D7) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Within 16 0 0.0 0 0.0 16 100 0 0.0 14 0 0.0 0 0.0 13 92.9 1 7.1 Above 0 - - - - - - - - 2 0 0.0 0 0.0 1 50.0 1 50.0 PI(D30) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Within 16 0 0.0 0 0.0 16 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 2 100 0 0.0 PI(D60) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Within 16 0 0.0 0 0.0 15 93.8 1 6.3 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 2 100 0 0.0 Creatinine PI(D7) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Below 0 - - - - - - - - 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 13 0 0.0 1 7.7 12 92.3 0 0.0 Above 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 PI(D30) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Below 0 - - - - - - - - 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 13 0 0.0 0 0.0 13 100 0 0.0 Above 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 PI(D60) Unknown 1 1 100 0 0.0 0 0.0 0 0.0 0 - - - - - - - - Below 0 - - - - - - - - 2 0 0.0 1 50.0 1 50.0 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 13 0 0.0 0 0.0 13 100 0 0.0 Above 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 Eosinophils PI(D7) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 1 50.0 1 50.0 PI(D30) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 15 100 0 0.0 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 1 50.0 1 50.0 PI(D60) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Within 15 0 0.0 0 0.0 14 93.3 1 6.7 14 0 0.0 0 0.0 14 100 0 0.0 Above 0 - - - - - - - - 2 0 0.0 0 0.0 0 0.0 2 100 Hemoglobin PI(D7) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 13 92.9 1 7.1 16 0 0.0 0 0.0 16 100 0 0.0 Above 1 0 0.0 0 0.0 0 0.0 1 100 0 - - - - - - - - PI(D30) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 0 0.0 15 93.8 1 6.3 Above 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - PI(D60) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 0 0.0 16 100 0 0.0 Above 1 0 0.0 0 0.0 0 0.0 1 100 0 - - - - - - - - WBC PI(D7) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 2 12.5 14 87.5 0 0.0

PI(D30) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 0 - - - - - - - - Within 14 0 0.0 1 7.1 13 92.9 0 0.0 16 0 0.0 1 6.3 15 93.8 0 0.0 PI(D60) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 1 100 0 0.0 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 1 6.3 15 93.8 0 0.0 Lymphocytes PI(D7) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 1 100 0 0.0 0 0.0 Within 14 0 0.0 1 7.1 13 92.9 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 PI(D30) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 1 100 0 0.0 0 0.0 Within 14 0 0.0 0 0.0 14 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 PI(D60) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 1 0 0.0 0 0.0 1 100 0 0.0 Within 14 0 0.0 1 7.1 13 92.9 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Neutrophils PI(D7) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 0 - - - - - - - - 1 0 0.0 1 100 0 0.0 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 1 6.7 14 93.3 0 0.0 PI(D30) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 0 - - - - - - - - 1 0 0.0 0 0.0 1 100 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 1 6.7 14 93.3 0 0.0 PI(D60) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 0 - - - - - - - - 1 0 0.0 1 100 0 0.0 0 0.0 Within 15 0 0.0 0 0.0 15 100 0 0.0 15 0 0.0 0 0.0 15 100 0 0.0 Platelets PI(D7) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 0 0.0 16 100 0 0.0 PI(D30) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 0 0.0 16 100 0 0.0 PI(D60) Unknown 2 1 50.0 0 0.0 1 50.0 0 0.0 0 - - - - - - - - Below 1 0 0.0 0 0.0 1 100 0 0.0 0 - - - - - - - - Within 14 0 0.0 0 0.0 14 100 0 0.0 16 0 0.0 0 0.0 16 100 0 0.0 N = number of subjects with available results for the specified laboratory parameter and timing in a given baseline category n/% = number/percentage of subjects in the specified category Unknown = missing normal laboratory range for the specified laboratory parameter Below = below the normal laboratory range defined for the specified laboratory parameter Within = within the normal laboratory range defined for the specified laboratory parameter Above = above the normal laboratory range defined for the specified laboratory parameter PI(D7) = Post-vaccination at Day 7 PI(D30) = Post-vaccination at Day 30 PI(D60) = Post-vaccination at Day 60 Primary Outcome Results: For results about unsolicited AEs and SAEs, please refer to the safety section of the document. Secondary Outcome Results: Number and percentage of subjects with Anti-RSV-A neutralizing antibody titer equal to or above the seropositivity threshold and GMTs, up to Day 60 (ATP cohort for immunogenicity)

8 ED60 GMT 95% CI 95% CI Antibody Timing N n % LL UL value LL UL Anti-RSV A Neutralizing Antibody RSV-LD PRE 14 14 100 76.8 100 425.7 259.6 698.0 PI(D7) 14 14 100 76.8 100 1023.6 652.4 1606.0 PI(D30) 14 14 100 76.8 100 1101.7 760.6 1595.7 PI(D60) 14 14 100 76.8 100 912.5 613.4 1357.4 RSV-LD alum PRE 15 15 100 78.2 100 603.5 402.5 904.8 PI(D7) 15 15 100 78.2 100 771.4 533.5 1115.5 PI(D30) 15 15 100 78.2 100 937.5 655.7 1340.6 PI(D60) 15 15 100 78.2 100 995.4 679.8 1457.3 RSV-MD PRE 14 14 100 76.8 100 680.9 433.6 1069.2 PI(D7) 14 14 100 76.8 100 1126.7 726.0 1748.4 PI(D30) 14 14 100 76.8 100 1296.7 759.5 2213.8 PI(D60) 14 14 100 76.8 100 1126.2 719.5 1762.8 RSV-MD alum PRE 15 15 100 78.2 100 630.1 329.6 1204.6 PI(D7) 15 15 100 78.2 100 1405.1 910.8 2167.7 PI(D30) 14 14 100 76.8 100 2214.0 1522.9 3218.7 PI(D60) 14 14 100 76.8 100 2072.1 1339.7 3204.8 RSV-HD PRE 15 15 100 78.2 100 373.1 251.9 552.4 PI(D7) 15 15 100 78.2 100 1314.4 966.9 1786.8 PI(D30) 15 15 100 78.2 100 1529.6 1044.5 2240.1 PI(D60) 15 15 100 78.2 100 1180.4 843.1 1652.8 RSV-HD alum PRE 14 14 100 76.8 100 277.9 212.3 363.8 PI(D7) 14 14 100 76.8 100 1280.7 907.3 1807.9 PI(D30) 13 13 100 75.3 100 1376.1 1007.7 1879.1 PI(D60) 14 14 100 76.8 100 1107.9 758.3 1618.7 Control 1 PRE 17 17 100 80.5 100 388.0 252.5 596.2 PI(D7) 17 17 100 80.5 100 381.0 253.4 572.9 PI(D30) 17 17 100 80.5 100 375.1 251.7 558.9 PI(D60) 17 17 100 80.5 100 371.3 250.2 551.1 Control 2 PRE 15 15 100 78.2 100 414.8 263.5 652.9 PI(D7) 15 15 100 78.2 100 406.5 259.2 637.7 PI(D30) 15 15 100 78.2 100 392.1 253.9 605.6 PI(D60) 15 15 100 78.2 100 413.4 265.8 642.8 GMT = geometric mean antibody titer calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with titer equal to or above specified value 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination at Day 0 PI(D7) = Post-vaccination at Day 7 PI(D30) = Post-vaccination at Day 30 PI(D60) = Post-vaccination at Day 60 Secondary Outcome Results: Number and percentage of subjects with Anti-RSV-B neutralizing antibody titer equal to or above the seropositivity threshold and GMTs, up to Day 60 (ATP cohort for immunogenicity) 6 ED60 GMT 95% CI 95% CI Antibody Timing N n % LL UL value LL UL Anti-RSV B RSV-LD PRE 14 14 100 76.8 100 597.9 358.0 998.6 Neutralizing PI(D7) 14 14 100 76.8 100 1144.1 754.1 1735.7 Antibody PI(D30) 14 14 100 76.8 100 1237.9 802.2 1910.3 RSV-LD alum PI(D60) 14 14 100 76.8 100 1150.6 760.4 1741.0 PRE 15 15 100 78.2 100 466.2 309.0 703.3 PI(D7) 15 15 100 78.2 100 599.1 394.8 909.2 PI(D30) 15 15 100 78.2 100 769.2 531.7 1112.7

PI(D60) 15 15 100 78.2 100 775.2 554.7 1083.4 RSV-MD PRE 14 14 100 76.8 100 595.8 397.5 893.2 PI(D7) 14 14 100 76.8 100 1070.6 711.0 1612.0 PI(D30) 14 14 100 76.8 100 1241.8 855.6 1802.4 PI(D60) 14 14 100 76.8 100 1282.1 899.9 1826.6 RSV-MD alum PRE 15 15 100 78.2 100 609.2 349.6 1061.5 PI(D7) 15 15 100 78.2 100 1089.6 709.1 1674.2 PI(D30) 14 14 100 76.8 100 1834.0 1143.7 2940.9 PI(D60) 14 14 100 76.8 100 1495.2 939.7 2379.2 RSV-HD PRE 15 15 100 78.2 100 431.3 313.5 593.5 PI(D7) 15 15 100 78.2 100 1370.8 1073.9 1749.7 PI(D30) 15 15 100 78.2 100 1441.8 1020.1 2037.8 PI(D60) 15 15 100 78.2 100 1061.7 728.7 1546.8 RSV-HD alum PRE 14 14 100 76.8 100 428.1 342.7 534.7 PI(D7) 14 14 100 76.8 100 1850.3 1250.7 2737.4 PI(D30) 13 13 100 75.3 100 1789.4 1245.9 2570.2 PI(D60) 14 14 100 76.8 100 1241.6 836.4 1843.1 Control 1 PRE 17 17 100 80.5 100 444.9 297.7 664.9 PI(D7) 17 17 100 80.5 100 451.2 301.0 676.4 PI(D30) 17 17 100 80.5 100 425.6 298.0 607.7 PI(D60) 17 17 100 80.5 100 455.6 301.3 689.0 Control 2 PRE 15 15 100 78.2 100 545.5 322.3 923.4 PI(D7) 15 15 100 78.2 100 501.5 293.7 856.6 PI(D30) 15 15 100 78.2 100 585.0 370.7 923.2 PI(D60) 15 15 100 78.2 100 478.5 301.3 759.9 GMT = geometric mean antibody titer calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with titer equal to or above specified value 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination at Day 0 PI(D7) = Post-vaccination at Day 7 PI(D30) = Post-vaccination at Day 30 PI(D60) = Post-vaccination at Day 60 Secondary Outcome Results: Number and percentage of subjects with ELISA Anti-RSV PreF antibody concentration equal to or above the seropositivity threshold and GMCs (ATP cohort for immunogenicity) 10 EU/mL GMC (EU/mL) 95% CI 95% CI Antibody Timing N n % LL UL value LL UL Anti-RSV RSV-LD PRE 14 14 100 76.8 100 1834.1 1167.0 2882.8 PreF PI(D7) 14 14 100 76.8 100 26811.1 19586.9 36699.7 antibody PI(D30) 14 14 100 76.8 100 29144.7 21614.3 39298.8 RSV-LD alum PI(D60) 14 14 100 76.8 100 20027.7 14482.5 27696.2 PRE 15 15 100 78.2 100 2022.0 1327.2 3080.5 PI(D7) 15 15 100 78.2 100 10588.1 6242.5 17958.8 PI(D30) 15 15 100 78.2 100 19528.0 14563.9 26184.3 PI(D60) 15 15 100 78.2 100 15243.2 10926.2 21265.7 RSV-MD PRE 14 14 100 76.8 100 3933.4 2139.0 7232.8 PI(D7) 14 14 100 76.8 100 28231.8 18000.2 44279.3 PI(D30) 14 14 100 76.8 100 43050.8 29179.8 63515.5 PI(D60) 14 14 100 76.8 100 34131.4 24962.2 46668.5 RSV-MD alum PRE 15 15 100 78.2 100 2282.1 1517.5 3431.8 PI(D7) 15 15 100 78.2 100 35736.2 22483.9 56799.6 PI(D30) 14 14 100 76.8 100 61107.3 39795.9 93831.3 PI(D60) 14 14 100 76.8 100 48844.5 30850.7 77333.3 RSV-HD PRE 15 15 100 78.2 100 2436.2 1650.8 3595.2

RSV-HD alum Control 1 Control 2 PI(D7) 15 15 100 78.2 100 54233.6 36718.9 80102.6 PI(D30) 15 15 100 78.2 100 69603.6 50724.4 95509.3 PI(D60) 15 15 100 78.2 100 46394.2 34215.6 62907.6 PRE 14 14 100 76.8 100 2986.8 2316.4 3851.2 PI(D7) 14 14 100 76.8 100 77439.1 56591.7 105966.4 PI(D30) 13 13 100 75.3 100 77638.6 59356.8 101551.2 PI(D60) 14 14 100 76.8 100 52323.6 37859.5 72313.5 PRE 17 17 100 80.5 100 2127.1 1565.1 2890.8 PI(D7) 17 17 100 80.5 100 2307.2 1684.6 3160.0 PI(D30) 17 17 100 80.5 100 2334.1 1693.1 3217.9 PI(D60) 17 17 100 80.5 100 2096.5 1563.8 2810.7 PRE 15 15 100 78.2 100 2882.4 1762.0 4715.0 PI(D7) 15 15 100 78.2 100 3087.1 1872.1 5090.7 PI(D30) 15 15 100 78.2 100 2932.6 1788.7 4808.1 PI(D60) 15 15 100 78.2 100 2648.9 1673.3 4193.4 GMC = geometric mean antibody concentration calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with concentration equal to or above specified value 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination at Day 0 PI(D7) = Post-vaccination at Day 7 PI(D30) = Post-vaccination at Day 30 PI(D60) = Post-vaccination at Day 60 Safety Results: Percentage of subjects reporting the occurrence of unsolicited AEs within the 30-day (Days 0-29) postvaccination period (Total Vaccinated cohort) Most frequent adverse events - On-Therapy (occurring within Days 0-29 following vaccination) RSV-LD RSV-LD alum RSV-MD RSV-MD alum RSV-HD RSV-HD alum Control 1 Control 2 N = 15 N = 17 Subjects with any AE(s), n (%) 4 (25.0) 6 (37.5) 5 (33.3) 4 (25.0) 6 (37.5) 4 (25.0) 4 (23.5) 3 (18.8) Headache - 2 (12.5) - - 3 (18.8) - 2 (11.8) - Cough 1 (6.3) 2 (12.5) - - - 1 (6.3) - - Injection site bruising 1 (6.3) - - 2 (12.5) - - - 1 (6.3) Upper respiratory tract infection 1 (6.3) 1 (6.3) - - - - 2 (11.8) - Nasopharyngitis - - 1 (6.7) 1 (6.3) - 1 (6.3) - - Rhinorrhoea 1 (6.3) - - - - - 1 (5.9) 1 (6.3) Aspartate aminotransferase increased - - - - 1 (6.3) - - 1 (6.3) Diarrhoea 1 (6.3) 1 (6.3) - - - - - - Myalgia - - 1 (6.7) 1 (6.3) - - - - Oropharyngeal pain - - - - 1 (6.3) 1 (6.3) - - Sinus headache - 1 (6.3) 1 (6.7) - - - - - Asthenia - - - - 1 (6.3) - - - Back pain - - 1 (6.7) - - - - - Constipation - - - - - - 1 (5.9) - Dizziness - - 1 (6.7) - - - - - Feeling hot - - - - 1 (6.3) - - - Gastroenteritis - - - - 1 (6.3) - - - Gastroenteritis viral - - - - - - - 1 (6.3) Laceration - 1 (6.3) - - - - - - Lymphadenopathy - - - - 1 (6.3) - - - Nasal congestion - 1 (6.3) - - - - - - Nausea 1 (6.3) - - - - - - - Pain in extremity - 1 (6.3) - - - - - - Pulmonary congestion - 1 (6.3) - - - - - - Pyrexia - - - - - 1 (6.3) - - Respiratory tract infection - - 1 (6.7) - - - - -

Rhinitis - - 1 (6.7) - - - - - Sinus congestion - - - - - - 1 (5.9) - Sinusitis 1 (6.3) - - - - - - - Throat irritation - 1 (6.3) - - - - - - Throat tightness - - 1 (6.7) - - - - - Viral infection - - - - - 1 (6.3) - - Safety Results: Number (%) of subjects with serious adverse events up to Day 60 (Total Vaccinated cohort) Serious Adverse Event, n (%) [n assessed by the investigator to be related to study medication] All SAEs Subjects with any SAE(s), n (%) [n assessed by the investigator as related] Fatal SAEs Subjects with any SAE(s), n (%) [n assessed by the investigator as related] RSV-LD RSV-LD alum RSV-MD N = 15 RSV-MD alum RSV-HD RSV-HD alum Control 1 N = 17 Control 2 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] RSV-LD RSV-LD alum RSV-MD N = 15 RSV-MD alum RSV-HD RSV-HD alum Control 1 N = 17 Control 2 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0)[0] 0 (0.0) [0] 0 (0.0)[0] Conclusion: During the 7-day (Days 0-6) post-vaccination period, pain at the injection site was the most frequently reported solicited local AE, reported by 12.5% (2 out of 16) of the subjects in the RSV-LD up to 81.3% (13 out of 16) of the subjects in the RSV-MD alum, as compared to 5.9% and 12.5% (1 and 2 subjects respectively) in CONTROL1 and CONTROL 2 groups respectively. Grade 3 pain was reported for 1 subject in the RSV-HD alum. During the 7-day (Days 0-6) post-vaccination period, fatigue and headache were the most frequently reported solicited general symptoms. Fatigue was reported for 18.8% of the subjects (3 out of 16) in the RSV-LD, RSV-MD alum and RSV-HD-alum s, up to 43.8% (7 out of 16) of the subjects in the RSV-LD alum and RSV-HD s, as compared to11.8% (2 subjects) and 25% ( 4 subjects) in CONTROL1 and CONTROL 2 s respectively. Grade 3 fatigue was reported for 1 subject in the RSV-LD (considered related to vaccination by the investigator) and by 2 subjects in the RSV-LD alum (considered non-related to vaccination by the investigator). Headache was reported by 12.5% (2 out of 16) of the subjects in the RSV-LD up to 43.8% (7 out of 16) of the subjects in the RSV-HD as compared to 11.8% (2 out of 17) and 37.5% (6 out of 16) in CONTROL1 and CONTROL 2 groups respectively.. Grade 3 headache was reported for 2 subjects in the RSV-LD alum (considered non-related to vaccination by the investigator). During the 30-day (Days 0-29) post-vaccination period, unsolicited AEs were reported for 4 (25%) subjects in the RSV-LD, RSV-MD alum and RSV-HD alum s, 5 (33.3%) subjects in the RSV-MD and 6 (37.5%) subjects in the RSV-LD alum and RSV-HD s as compared to 4 (23.5%) and 3 (18.8%) subjects in CONTROL1 and CONTROL 2 s respectively. No SAEs were reported up to Day 60. Date updated: 17-Nov-2014

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