Analysis of immunogenicity

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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. Study No.: 115418 (FLU-Q-QIV-(T+)-009) Title: A Phase IIIA study of immunogenicity and safety of GSK Biologicals quadrivalent split virion influenza vaccine FLU- Q-QIV in adults aged 18 years and older. FLU-Q-QIV (Flu): GlaxoSmithKline (GSK) Biologicals Quadrivalent Split Virion Influenza Vaccine. Rationale: The purpose of this study was to evaluate the immunogenicity and safety of Flu vaccine in adults 18 years of age and older. Phase: IIIA Study Period: 30 September 2011 to 22 October 2011 Study Design: Open-label, single group study with 2 parallel age strata (18 to 60 years and > 60 years). Centres: One centre in Canada. Indication: Immunisation against influenza of healthy adults aged 18 years and older. Treatment: The study groups were as follows: : Subjects aged 18 to 60 years. : Subjects aged > 60 years. All subjects received one dose of Flu vaccine at Day 0, administered intramuscularly in the deltoid region of the nondominant arm. Objectives: To evaluate the immunogenicity of Flu vaccine against each of the 4 included viral strains in adults aged 18 years and older, 21 days after vaccination, by analysis of haemagglutination inhibition (HI) antibody titres. Primary Outcome/Efficacy Variable: Immunogenicity: Humoral immune response in terms of HI antibodies against each of the 4 vaccine influenza strains. The following parameters: Geometric mean titres (GMTs) of HI antibody titres at Days 0 and 21. Seroprotection rates ([SPR] -defined as percentage of vaccinees with serum HI titre 1:40 usually accepted as indicating protection) at Days 0 and 21. Seroconversion rates ([SCR]-defined as the percentage of vaccinees with either a pre-vaccination titre < 1:10 and a post-vaccination titre 1:40 or a pre-vaccination titre 1:10 and at least 4-fold increase in postvaccination titre) at Day 21. Seroconversion factors (SCF) -defined as the fold increase in serum HI GMTs post-vaccination at Day 21 compared to Day 0. Secondary Outcome/Efficacy Variable(s): Safety: Solicited local and general symptoms Occurrence of each solicited local and general symptom within 4 days (Day 0 - Day 3) after vaccination. Unsolicited adverse events Occurrence of unsolicited adverse events (AEs) within 21 days (Day 0 - Day 20) after vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. Serious adverse events Occurrence of serious adverse events (SAEs) from start of study participation through the entire study period (Day 0 - Day 20 after vaccination). Statistical Methods: The analyses were based on the Total Vaccinated cohort and on the According-To-Protocol (ATP) cohort for immunogenicity. The Total Vaccinated cohort included all vaccinated subjects. The ATP cohort for immunogenicity included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Analysis of immunogenicity

The analysis was based on the ATP cohort for immunogenicity. For the humoral immune response in terms of HI antibodies against each of the 4 vaccine influenza strains, the following parameters (with 95% CIs) were calculated for both age groups: Seropositivity rates and GMTs of HI antibody titres at Day 0 and Day 21. SPR at Day 0 and Day 21. SCR at Day 21. SCF at Day 21. Analysis of safety The analysis was based on the Total Vaccinated cohort. The percentage of subjects reporting each individual solicited local and general symptom during the 4- day (Day 0 - Day 3) solicited follow-up period after vaccination was tabulated for both groups with exact 95% CI. The same tabulations were performed for symptoms with intensity of grade 3 and for general symptoms assessed by the investigators as causally related to the vaccination. The percentage of subjects with at least one report of an unsolicited AE classified by the MedDRA preferred terms and reported up to 21 days after vaccination was tabulated. The percentage of subjects with SAEs during the entire study period was tabulated according to MedDRA preferred terms. Study Population: Healthy male or female adults over 18 years of age at the time of the first vaccination who had satisfactory baseline medical assessment by medical history and physical examination were enrolled in the study. Women of childbearing potential had to have practiced adequate contraception for 30 days prior to vaccination, had to have a negative pregnancy test, and were to continue such precautions for 2 months after vaccination. Subjects with administration of an influenza vaccine within 6 months preceding the study start were not included in the study. Written informed consent was obtained from the subject prior to study entry. Number of Subjects: Planned, N 56 56 Randomised, N (Total Vaccinated cohort) 56 56 Completed, n (%) 56 (100) 56 (100) Total Number Subjects Withdrawn, n (%) 0 (0.0) 0 (0.0) Withdrawn due to Adverse Events, n (%) 0 (0.0) 0 (0.0) Withdrawn due to Lack of Efficacy, n (%) Not applicable Not applicable Withdrawn for other reasons, n (%) 0 (0.0) 0 (0.0) Demographics N (Total Vaccinated cohort) 56 56 Females : Males 34:22 30:26 Mean Age, years (SD) 40.9 (13.33) 68.6 (4.72) White - Caucasian / European heritage, n (%) 54 (96.4) 56 (100) Primary Efficacy Results: Seropositivity rates and GMTs for HI antibodies titres at Day 0 and Day 21 (ATP cohort for immunogenicity) 1:10 GMT* 95% CI 95% CI Antibody Group Timing N n % LL UL Value LL UL against Flu B/Florida/4/06 (Yamagata) FluB/Bri/60/08 (Victoria) Flu A/CAL/7/09 (H1N1) Flu A/Victoria/210/ 09 (H3N2) Flu Adult PRE 56 56 100 93.6 100 130.4 92.8 183.2 PI(D21) 56 56 100 93.6 100 404.8 323.1 507.2 Flu Elderly PRE 56 54 96.4 87.7 99.6 57.3 44.3 74.0 PI(D21) 56 56 100 93.6 100 355.5 263.5 479.5 Flu Adult PRE 56 54 96.4 87.7 99.6 92.8 66.5 129.4 PI(D21) 56 56 100 93.6 100 318.0 251.4 402.3 Flu Elderly PRE 56 52 92.9 82.7 98.0 38.5 28.3 52.4 PI(D21) 56 56 100 93.6 100 237.8 179.7 314.9 Flu Adult PRE 56 49 87.5 75.9 94.8 82.0 54.9 122.5 PI(D21) 56 56 100 93.6 100 392.5 305.4 504.4 Flu Elderly PRE 56 40 71.4 57.8 82.7 25.0 17.3 36.0 PI(D21) 56 55 98.2 90.4 100 223.5 157.0 318.1 Flu Adult PRE 56 49 87.5 75.9 94.8 45.3 31.3 65.4 PI(D21) 56 56 100 93.6 100 215.4 166.3 278.9 Flu Elderly PRE 56 40 71.4 57.8 82.7 23.2 16.4 32.8

PI(D21) 56 55 98.2 90.4 100 160.1 115.7 221.4 GMT = geometric mean antibody titre calculated on all subjects N = number of subjects with available results Seropositivity defined as the percentage of subjects with antibody titres 1:10 n/% = number/percentage of subjects with titre within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination (Day 0) PI(D21) = 21 days after vaccination * Primary outcome variable Primary Efficacy Results: SPR for HI antibodies titres at Day 0 and Day 21 (ATP cohort for immunogenicity) SPR 95% CI Antibody against Group Timing N n % LL UL Flu B/Florida/4/06 (Yamagata) Flu Adult PRE 56 48 85.7 73.8 93.6 PI(D21) 56 56 100 93.6 100 Flu Elderly PRE 56 45 80.4 67.6 89.8 PI(D21) 56 56 100 93.6 100 FluB/Bri/60/08 (Victoria) Flu Adult PRE 56 47 83.9 71.7 92.4 PI(D21) 56 56 100 93.6 100 Flu Elderly PRE 56 31 55.4 41.5 68.7 PI(D21) 56 55 98.2 90.4 100 Flu A/CAL/7/09 (H1N1) Flu Adult PRE 56 44 78.6 65.6 88.4 PI(D21) 56 55 98.2 90.4 100 Flu Elderly PRE 56 26 46.4 33.0 60.3 PI(D21) 56 52 92.9 82.7 98.0 Flu A/Victoria/210/09 (H3N2) Flu Adult PRE 56 34 60.7 46.8 73.5 PI(D21) 56 54 96.4 87.7 99.6 Flu Elderly PRE 56 28 50.0 36.3 63.7 PI(D21) 56 53 94.6 85.1 98.9 SPR defined as the percentage of subjects with antibody titre 1:40 N = number of subjects with available results n/% = number/percentage of seroprotected subjects (HI titre 1:40) 95% CI = 95% confidence interval, LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination (Day 0) PI(D21) = 21 days after vaccination Primary Efficacy Results: SCR for HI antibodies titres at Day 21 (ATP cohort for immunogenicity) SCR 95% CI Antibody against Group N n % LL UL Flu B/Florida/4/06 (Yamagata) Flu Adult 56 20 35.7 23.4 49.6 Flu Elderly 56 35 62.5 48.5 75.1 FluB/Bri/60/08 (Victoria) Flu Adult 56 19 33.9 21.8 47.8 Flu Elderly 56 33 58.9 45.0 71.9 Flu A/CAL/7/09 (H1N1) Flu Adult 56 28 50.0 36.3 63.7 Flu Elderly 56 34 60.7 46.8 73.5 Flu A/Victoria/210/09 (H3N2) Flu Adult 56 27 48.2 34.7 62.0 Flu Elderly 56 35 62.5 48.5 75.1 Seroconversion defined as: For initially seronegative subjects, antibody titre 1:40 after vaccination For initially seropositive subjects, antibody titre after vaccination 4 fold the pre-vaccination antibody titre N = number of subjects with pre- and post-vaccination results available n/% = number/percentage of seroconverted subjects 95% CI = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Primary Efficacy Results: SCF for HI antibodies titres at Day 21 (ATP cohort for immunogenicity) SCF 95% CI

Antibody against Group N Value LL UL Flu B/Florida/4/06 (Yamagata) Flu Adult 56 3.1 2.4 4.0 Flu Elderly 56 6.2 4.6 8.4 FluB/Bri/60/08 (Victoria) Flu Adult 56 3.4 2.5 4.6 Flu Elderly 56 6.2 4.3 8.8 Flu A/CAL/7/09 (H1N1) Flu Adult 56 4.8 3.3 7.0 Flu Elderly 56 8.9 5.8 13.7 Flu A/Victoria/210/09 (H3N2) Flu Adult 56 4.8 3.5 6.6 Flu Elderly 56 6.9 4.7 10.1 SCF is defined as the fold increase in serum HI GMTs post-vaccination at Day 21 compared to Day 0. N = number of subjects with pre- and post-vaccination results available SCF = Fold increase in serum HI GMTs post-vaccination 95% CI = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): Incidence of solicited local symptoms reported during the 4-day (Days 0-3) postvaccination period (Total Vaccinated cohort) 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL Pain Any 56 41 73.2 59.7 84.2 56 19 33.9 21.8 47.8 Redness Any 56 1 1.8 0.0 9.6 56 0 0.0 0.0 6.4 >100 mm 56 0 0.0 0.0 6.4 56 0 0.0 0.0 6.4 Swelling Any 56 1 1.8 0.0 9.6 56 2 3.6 0.4 12.3 >100 mm 56 0 0.0 0.0 6.4 56 0 0.0 0.0 6.4 N= number of subjects with the documented dose n (%)= number/percentage of subjects reported at least once the symptom 95% CI = exact 95% confidence interval, LL = Lower Limit, UL = Upper Limit Any= occurrence of any local symptom regardless of their intensity grade Grade 3 pain= pain that prevented normal activity Secondary Outcome Variable(s): Incidence of solicited general symptoms reported during the 4-day (Days 0-3) postvaccination period (Total Vaccinated Cohort) 95 % CI 95 % CI Symptom Intensity/Relationship N n % LL UL N n % LL UL Chest tightness Any 56 0 0.0 0.0 6.4 56 2 3.6 0.4 12.3 Related 56 0 0.0 0.0 6.4 56 2 3.6 0.4 12.3 Chills Any 56 1 1.8 0.0 9.6 56 5 8.9 3.0 19.6 Related 56 1 1.8 0.0 9.6 56 5 8.9 3.0 19.6 Cough Any 56 3 5.4 1.1 14.9 56 4 7.1 2.0 17.3 Related 56 3 5.4 1.1 14.9 56 4 7.1 2.0 17.3 Fatigue Any 56 10 17.9 8.9 30.4 56 5 8.9 3.0 19.6 Grade 3 56 0 0.0 0.0 6.4 56 1 1.8 0.0 9.6 Related 56 10 17.9 8.9 30.4 56 5 8.9 3.0 19.6 Headache Any 56 11 19.6 10.2 32.4 56 5 8.9 3.0 19.6 Related 56 11 19.6 10.2 32.4 56 5 8.9 3.0 19.6 Joint pain at other location Any 56 7 12.5 5.2 24.1 56 3 5.4 1.1 14.9 Related 56 7 12.5 5.2 24.1 56 3 5.4 1.1 14.9 Muscle pain Any 56 21 37.5 24.9 51.5 56 6 10.7 4.0 21.9 Grade 3 56 0 0.0 0.0 6.4 56 1 1.8 0.0 9.6 Related 56 21 37.5 24.9 51.5 56 6 10.7 4.0 21.9 Red eyes Any 56 3 5.4 1.1 14.9 56 0 0.0 0.0 6.4

Related 56 3 5.4 1.1 14.9 56 0 0.0 0.0 6.4 Sore throat Any 56 7 12.5 5.2 24.1 56 5 8.9 3.0 19.6 Related 56 7 12.5 5.2 24.1 56 5 8.9 3.0 19.6 Swelling of the face Any 56 0 0.0 0.0 6.4 56 0 0.0 0.0 6.4 Related 56 0 0.0 0.0 6.4 56 0 0.0 0.0 6.4 Fever/ (Orally) 38.0ºC 56 0 0.0 0.0 6.4 56 0 0.0 0.0 6.4 39 C 56 0 0.0 0.0 6.4 56 0 0.0 0.0 6.4 Related 56 0 0.0 0.0 6.4 56 0 0.0 0.0 6.4 N= number of subjects with the documented 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 any general symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity Grade 3 red eyes = very reddened, interfered with the vision or caused to see a doctor Grade 3 swelling of the face = very swollen, prevented work/normal activities or caused to see a doctor Related = general symptom assessed by the investigator as causally related to the study vaccination Safety Results: Number (%) of subjects with unsolicited AEs within the 21-day post-vaccination period (Total Vaccinated cohort) Most frequent adverse events - On-Therapy (occurring within Days 0-20 following vaccination) Subjects with any AE(s), n (%) 13 (23.2) 12 (21.4) Upper respiratory tract infection 6 (10.7) 3 (5.4) Nasal congestion 2 (3.6) - Arthralgia - 1 (1.8) Arthropod sting - 1 (1.8) Back pain 1 (1.8) - Bronchitis 1 (1.8) - Chronic obstructive pulmonary disease - 1 (1.8) Diarrhoea 1 (1.8) - Dizziness - 1 (1.8) Headache - 1 (1.8) Injection site haemorrhage - 1 (1.8) Laryngitis 1 (1.8) - Ligament sprain - 1 (1.8) Musculoskeletal stiffness - 1 (1.8) Myalgia 1 (1.8) - Nausea 1 (1.8) - Oropharyngeal pain - 1 (1.8) Pain - 1 (1.8) Pain in jaw 1 (1.8) - Pneumonia 1 (1.8) - Rhinorrhoea - 1 (1.8) Sinusitis 1 (1.8) - Vaginal infection 1 (1.8) - - : adverse event absent Safety results: Number (%) of subjects with SAEs during the entire study period (Days 0-20) (Total Vaccinated cohort) Serious adverse event, n (%) [n considered by the investigator to be related to study medication] All SAEs Subjects with any SAE(s), n (%) [n assessed by the investigator as related] 0 (0.0) [0] 0 (0.0) [0] Fatal SAEs Subjects with fatal SAE(s), n (%)[n assessed by the investigator as related] 0 (0.0) [0] 0 (0.0) [0]

Conclusion: Before vaccination, GMTs for the 4 influenza strains, Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2),were 130.4, 92.8, 82.0 45.3 respectively in the Flu Adult Group and were 57.3, 38.5, 25.0 and 23.2 respectively in the. At Day 21 after vaccination, the GMTs for the 4 influenza strains, Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2),were 404.8, 318.0, 392.5 and 215.4 respectively in the and were 355.5, 237.8, 223.5 and 160.1 in the. In Flu Adult group across the 4 influenza strains, the SPR, was at least 60.7% before vaccination and at least 96.4% at Day 21 after vaccination and in Flu Elderly group across the 4 influenza strains, the SPR was at least 46.4% before vaccination and at least 92.9% at Day 21 after vaccination. At Day 21, the SCR was at least 33.9% in Flu Adult group and 58.9% in the Flu Elderly group, across the 4 influenza strains. At the same time-point, the SCF was at least 3.1% in the Flu Adult group and at least 6.2% in the Flu elderly group, across the 4 influenza strains. During the 21 days following vaccination, 13 (23.2%) subjects in the and 12 (21.4%) subjects in the Flu Elderly Group reported at least one unsolicited AE. No SAEs were reported during the study period. Date updated: 09-June-2014

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