Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
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- Gwendolyn Lynch
- 6 years ago
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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 H1N1-031) Title: Safety and immunogenicity study of GSK Biologicals pandemic influenza (H1N1) candidate vaccine (GSK A) in children aged 10 to less than 18 years. Arepanrix - GSK A (Flu1): GlaxoSmithKline (GSK) Biologicals adjuvanted A/California/7/2009 (H1N1)v-like vaccine produced in Quebec. Rationale: The aim of the study was to assess the safety and immunogenicity of different formulations of Flu1 vaccine. It also aimed to investigate the safety and immunogenicity of Flu2 vaccine GSK A (Flu2): GSK Biologicals unadjuvanted A/California/7/2009 (H1N1)v-like vaccine produced in Quebec. Phase: II Study Period: 09 February 2010 to: 01 July 2010 (Day 42) 10 May 2011 (Day 364) Study Design: Randomized (3:3:3:5), observer blind, multicountry, multicentre study with 4 parallel groups Centers: 1 centre in Estonia and 5 centers in Slovakia. Indication: Immunization of healthy children aged 10 to less than 18 years against A/California/7/2009 (H1N1)v-like influenza Treatment: The study groups were as follows: Flu1-F1-2D : subjects received 2 doses of Flu1 formulation 1 vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. Flu1-F2-2D : received 2 doses of Flu1 formulation 2 vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. Flu1-F2-3D : subjects received 3 doses of Flu1 formulation 2 vaccine on Day 0, Day 21 and Day 182 (booster). Flu2-2D : subjects received 2 doses of Flu2 vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. All vaccines were administered intramuscularly, in the non-dominant deltoid on Day 0 and Day 182 and in the dominant deltoid on Day 21. Objectives: To assess whether vaccination with Flu1 or Flu2 vaccine resulted in an immune response to the vaccine-homologous virus that met or exceeded the Committee for Medicinal Products for Human Use (CHMP) guidance targets for pandemic vaccine seroconversion rate (SCR), rate of induction of vaccine-homologous reciprocal hemagglutination inhibition (HI) titers 40 (potential seroprotection rate [SPR]) and geometric mean fold rise (GMFR) 21 days after the first dose of Flu1 or Flu2 vaccine in children 10 to < 18 years of age. The CHMP Criteria were fulfilled if: the point estimate for SCR was > 40% and the post-vaccination point estimate for SPR was > 70% and the point estimate for GMFR was > 2.5 Primary Outcome/Efficacy Variable: Humoral immune response in terms of HI antibodies Vaccine virus-homologous responses as demonstrated by the HI antibody titers 21 days after the first dose of H1N1 vaccine (Day 21) Derived aggregate variables to evaluate the primary objective: SCR* at Day 21 SPR** at Day 21 GMFR*** at Day 21 * SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer 40, or a pre-vaccination reciprocal HI titer 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. ** SPR was defined as the proportion of subjects with H1N1 reciprocal HI titers 40 against the tested vaccine virus. *** GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. Secondary Outcome/Efficacy Variable(s): Immunogenicity Humoral immune response in terms of HI antibodies Against A/California/7/2009 (H1N1)v-like antigen
2 Derived aggregate variables: Geometric mean titers (GMTs) and seropositivity rates at Day 0, Day 21, Day 42, Day 182 and Day 189 SCR* at Day 42, Day 182 and Day 189 SPR* at Day 0, Day 42, Day 182 and Day 189 GMFR* at Day 42, Day 182 and Day 189 Humoral immune response in terms of HI antibodies Against any drifted strain from A/California/7/2009 (H1N1)v-like in all subjects Derived aggregate variables: GMTs and seropositivity rates at Day 0, Day 21, Day 42, Day 182 and Day 189 SCR* at Day 21, Day 42, Day 182 and Day 189 SPR* at Day 0, Day 21, Day 42, Day 182 and Day 189 GMFR* (or SCF) at Day 42, Day 182 and Day 189 Humoral immune response in terms of microneutralization (MN) antibodies Against A/California/7/2009 (H1N1)v-like vaccine homologous and heterologous virus in all subjects Derived aggregate variables: GMTs of serum MN antibodies at Day 0, Day 21, Day 42, Day 182 and Day 189 Seropositivity rates of serum MN antibodies at Day 0, Day 21, Day 42, Day 182 and Day 189 Vaccine response rates (VRR**) on Day 21, Day 42, Day 182 and Day 189 Safety Solicited local and general symptoms The occurrence of specifically-solicited local and general signs and symptoms during a 7-day follow up period after each dose of vaccine (i.e., day of vaccination and six subsequent days). Unsolicited adverse events The occurrence of all unsolicited adverse events (AEs) during a 21-day follow-up period after each vaccine dose (i.e., day of vaccination and 20 subsequent days). Medically attended events (MAEs), serious adverse events (SAEs), potential Immune-Mediated Disease (pimds) The occurrence of all MAEs, SAEs, pimds throughout the study period (i.e., day of the first vaccine dose [Day 0] until Day 364 telephone contact) Clinical laboratory (complete blood count [CBC], alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], serum urea nitrogen [SUN], bilirubin) abnormalities for all venipuncture days. * Please refer to primary outcome variables for definition. At the time of writing this summary these results were not yet available. This summary will be updated when additional data become available. ** VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. Statistical Methods: The analyses were performed on the Total Vaccinated cohort and the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, Day 42, Day 182 and Day 189. The Total Vaccinated cohort included all vaccinated subjects The ATP cohort for immunogenicity at Day 21 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 the injection site of study/control vaccine was known, who received the vaccine dose on Day 0 as per protocol treatment assignment and for whom assay results for antibodies against A/California-like hemagglutinin (HA) antigen for the blood sample taken 21 days after the first vaccination were available. The ATP cohort for immunogenicity at Day 42 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 the injection site of study/control vaccine was known, who received the vaccine/placebo doses on both Day 0 and Day 21 as per protocol treatment assignment and for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken on Days 21 and 42 (21 days after the first and second vaccinations) were available. The ATP cohort for immunogenicity at Day 182 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 the injection site of study/control vaccine was known, who received the vaccine/placebo doses on both
3 Day 0 and Day 21 as per protocol treatment assignment and for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken 21, 42 and 182 days after the first vaccination were available. The ATP cohort for immunogenicity at Day 189 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 the injection site of study/control vaccine was known, who received the vaccine/placebo doses on both Day 0 and Day 21 and the booster dose on Day 182 as per protocol treatment assignment and for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken 21, 42 and 182 days after the first vaccination and 7 days after the booster dose were available. Analysis of Immunogenicity: The analysis of immunogenicity was performed on the ATP cohort for immunogenicity at Day 21, Day 42, Day 182 and Day 189. Point estimates for SCR, SPR, GMFR and the associated 95% confidence interval (CI) were computed at Day 21 after the first dose. SCR (at Days, 42, 182 and 189), SPR (at Days 0, 42,182 and 189), GMFR (at Days, 42, 182 and 189), GMTs and seropositivity rates (at Days 0, 21, 42, 182 and 189) were also calculated with their for Flu A/CAL/7/09. Analysis of Safety: The analysis of safety was performed on the Total Vaccinated cohort. For each solicited symptom, the percentage of subjects with the symptom and its exact was summarized by groups, by dose and across doses during the 7 days following each vaccination. The same calculations were performed for symptoms of any intensity, those with intensity of grade 3 as well as for solicited general symptoms assessed by the investigators as related to vaccination. The percentage of subjects reporting unsolicited symptoms within 42 days (Day 0-41) following the first vaccination was summarized by group according to the Medical Dictionary for Regulatory Activities (MedDRA) preferred term; the same summary was performed for the unsolicited symptoms occurring within 21 days after the booster vaccination. MAEs, pimds (autoimmune diseases and other immune mediated inflammatory disorders) and SAEs were summarized according to MedDRA preferred terms up to Day 364. Clinical laboratory data were summarized with respect to the normal laboratory ranges at Day 0, 21, 42, 182 and 189. Study Population: Healthy male or female children 10 to < 18 years of age at the time of the first vaccination (which implied inclusion of adolescents who had not reached their 18 th birthday on Day 0) who had no medical history of physician-confirmed infection with A/California/7/2009 (H1N1) v-like virus, were not previously vaccinated with A/California/7/2009 (H1N1) v-like virus vaccine or any other investigational or non-registered product within 30 days prior to the first dose of study vaccine or during the study, had not received any other vaccine not foreseen by the study protocol between Day 0 and Day 42 (childhood vaccinations were exempted if no delay was possible, but were not administered on the same day as the study vaccine) and were not diagnosed with cancer or had had treatment for cancer within 3 years. Written/informed consent was obtained from the subject s parent/legally acceptable representative and assent from the subject if appropriate prior to study entry. Number of subjects Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D Planned, N Randomized, N (Total Vaccinated cohort) Completed to Day 42, n (%) 66 (100) 66 (100) 68 (100) 110 (100) Completed to Day 364, n (%) 65 (98.5) 65 (98.5) 68 (100) 110 (100) Total Number Subjects Withdrawn, n (%) 1 (1.5) 1 (1.5) 0 (0.0) 0 (0.0) Withdrawn due to Adverse Events, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Withdrawn due to Lack of Efficacy, n (%) Not applicable Not applicable Not applicable Not applicable Withdrawn for other reasons, n (%) 1 (1.5) 1 (1.5) 0 (0.0) 0 (0.0) Demographics Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D N (Total Vaccinated cohort) Females:Males 37:29 32:34 38:30 59:51 Mean Age, years (SD) 13.6 (2.27) 14.5 (2.20) 14.6 (1.84) 14.1 (2.13) White - Caucasian / European heritage, n (%) 66 (100) 66 (100) 68 (100) 110 (100) Primary Efficacy Results: SCR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 21 (ATP cohort for immunogenicity at Day 21)
4 SCR Strain N N % LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D Seroconversion defined as: - For initially seronegative subjects, antibody titer 1:40 after vaccination - For initially seropositive subjects, antibody titer after vaccination 4 fold the pre-vaccination antibody titer N = Number of subjects with pre- and post-vaccination results available n/% = Number/percentage of seroconverted subjects = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Primary Efficacy Results: SPR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 0 and Day 21 (ATP cohort for immunogenicity at Day 21) SPR Strain Timing N n % LL UL Flu A/CAL/7/09 Flu1-F1-2D PRE PI(D21) Flu1-F2-2D PRE PI(D21) Flu1-F2-3D PRE PI(D21) Flu2-2D PRE PI(D21) N = Number of subjects with available results n/% = Number/percentage of seroprotected subjects (HI titer 1:40) = 95% confidence interval, LL = Lower Limit, UL = Upper Limit PI(D21) = Post-vaccination Day 21 PRE = Pre-vaccination Day 0 Primary Efficacy Results: GMFR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 21 (ATP cohort for immunogenicity at Day 21) GMFR Strain N Value LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D N = Number of subjects with pre- and post-vaccination results available GMFR = Geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): Seropositivity rates and GMTs for HI antibodies against Flu A/CAL/7/09 H1N1 (ATP cohort for immunogenicity at Day 21) 1:10 GMT Antibody Timing N n % LL UL value LL UL Flu Flu1-F1-2D PRE A/CAL/7/09 PI(D21) Flu1-F2-2D PRE PI(D21) Flu1-F2-3D PRE PI(D21) Flu2-2D PRE
5 PI(D21) 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% confidence interval; LL = Lower Limit, UL = Upper Limit PI(D21) = Post-vaccination Day 21 PRE = Pre-vaccination Day 0 Secondary Outcome Variable(s): Seropositivity rates and GMTs for HI antibodies against Flu A/CAL/7/09 H1N1 (ATP cohort for immunogenicity at Day 42) 1:10 GMT Antibody Timing N n % LL UL value LL UL Flu A/CAL/7/09 Flu1-F1-2D PRE PII(D42) Flu1-F2-2D PRE PII(D42) Flu1-F2-3D PRE PII(D42) Flu2-2D PRE PII(D42) 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% confidence interval; LL = Lower Limit, UL = Upper Limit PII(D42) = Post-vaccination Day 42 PRE = Pre-vaccination Day 0 Secondary Outcome Variable(s): Seropositivity rates and GMTs for HI antibodies against Flu A/CAL/7/09 H1N1 (ATP cohort for immunogenicity at Day 182) 1:10 GMT Antibody Timing N n % LL UL value LL UL Flu A/CAL/7/09 Flu1-F1-2D PRE PII(D182) Flu1-F2-2D PRE PII(D182) Flu1-F2-3D PRE PII(D182) Flu2-2D PRE PII(D182) 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% confidence interval; LL = Lower Limit, UL = Upper Limit PII (D182) = Post-vaccination Day 182 PRE = Pre-vaccination Day 0 Secondary Outcome Variable(s): Seropositivity rates and GMTs for HI antibodies against Flu A/CAL/7/09 H1N1 (ATP cohort for immunogenicity at Day 189) 1:10 GMT Antibody Timing N n % LL UL value LL UL Flu A/CAL/7/09 Flu1-F1-2D PRE PII(D182) PIII(D189) Flu1-F2-2D PRE PII(D182)
6 PIII(D189) Flu1-F2-3D PRE PII(D182) PIII(D189) Flu2-2D PRE PII(D182) PIII(D189) 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% confidence interval; LL = Lower Limit, UL = Upper Limit PII (D182) = Post-vaccination Day 182 PIII (D189) = Post-vaccination Day 189 PRE = Pre-vaccination Day 0 Secondary Outcome Variable(s): SCR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 42 (ATP cohort for immunogenicity at Day 42) SCR Strain N n % LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D Seroconversion defined as: - For initially seronegative subjects, antibody titer 1:40 after vaccination - For initially seropositive subjects, antibody titer after vaccination 4 fold the pre-vaccination antibody titer N = Number of subjects with pre- and post-vaccination results available n/% = Number/percentage of seroconverted subjects = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): SCR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 182 (ATP cohort for immunogenicity at Day 182) SCR Strain N n % LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D Seroconversion defined as: - For initially seronegative subjects, antibody titer 1:40 after vaccination - For initially seropositive subjects, antibody titer after vaccination 4 fold the pre-vaccination antibody titer N = Number of subjects with pre- and post-vaccination results available n/% = Number/percentage of seroconverted subjects = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): SCR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 189, using Day 0 as reference activity (ATP cohort for immunogenicity at Day 189) SCR Strain N n % LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D Seroconversion defined as: - For initially seronegative subjects, antibody titer 1:40 after vaccination
7 - For initially seropositive subjects, antibody titer after vaccination 4 fold the pre-vaccination antibody titer N = Number of subjects with pre- and post-vaccination results available n/% = Number/percentage of seroconverted subjects = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): SCR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 189, using Day 182 as reference activity (ATP cohort for immunogenicity at Day 189) SCR Strain N n % LL UL Flu A/CAL/7/09 Flu1-F2-2D Flu1-F2-3D Flu2-2D Flu1-F1-2D Seroconversion defined as: - For initially seronegative subjects, antibody titer 1:40 after vaccination - For initially seropositive subjects, antibody titer after vaccination 4 fold the pre-vaccination antibody titer N = Number of subjects with pre- and post-vaccination results available n/% = Number/percentage of seroconverted subjects = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): SPR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 0 and Day 42 (ATP cohort for immunogenicity at Day 42) SPR Strain Timing N n % LL UL Flu A/CAL/7/09 Flu1-F1-2D PRE PII(D42) Flu1-F2-2D PRE PII(D42) Flu1-F2-3D PRE PII(D42) Flu2-2D PRE PII(D42) N = Number of subjects with available results n/% = Number/percentage of seroprotected subjects (HI titer 1:40) = 95% confidence interval, LL = Lower Limit, UL = Upper Limit PII(D42) = Post-vaccination Day 42 PRE = Pre-vaccination Day 0 Secondary Outcome Variable(s): SPR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 0 and Day 182 (ATP cohort for immunogenicity at Day 182) SPR Strain Timing N n % LL UL Flu A/CAL/7/09 Flu1-F1-2D PRE PII(D182) Flu1-F2-2D PRE PII(D182) Flu1-F2-3D PRE PII(D182) Flu2-2D PRE PII(D182) N = Number of subjects with available results n/% = Number/percentage of seroprotected subjects (HI titer 1:40) = 95% confidence interval, LL = Lower Limit, UL = Upper Limit PII(D182) = Post-vaccination Day 182 PRE = Pre-vaccination Day 0
8 Secondary Outcome Variable(s): SPR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 0, Day 182 and Day 189 (ATP cohort for immunogenicity at Day 189) SPR Strain Timing N n % LL UL Flu A/CAL/7/09 Flu1-F1-2D PRE PII(D182) PIII(D189) Flu1-F2-2D PRE PII(D182) PIII(D189) Flu1-F2-3D PRE PII(D182) PIII(D189) Flu2-2D PRE PII(D182) PIII(D189) N = Number of subjects with available results n/% = Number/percentage of seroprotected subjects (HI titer 1:40) = 95% confidence interval, LL = Lower Limit, UL = Upper Limit PII(D182) = Post-vaccination Day 182 PIII(D189) = Post-vaccination Day 189 PRE = Pre-vaccination Day 0 Secondary Outcome Variable(s): GMFR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 42 (ATP cohort for immunogenicity at Day 42) GMFR Strain N Value LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D N = Number of subjects with pre- and post-vaccination results available GMFR = Geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): GMFR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 182 (ATP cohort for immunogenicity at Day 182) GMFR Strain N Value LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D N = Number of subjects with pre- and post-vaccination results available GMFR = Geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): GMFR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 189, using Day 0 as reference activity (ATP cohort for immunogenicity at Day 189) GMFR Strain N Value LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D
9 Flu2-2D N = Number of subjects with pre- and post-vaccination results available GMFR = Geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): GMFR for HI antibodies against Flu A/CAL/7/09 H1N1 at Day 189, using Day 182 as reference activity (ATP cohort for immunogenicity at Day 189) GMFR Strain N Value LL UL Flu A/CAL/7/09 Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D Flu2-2D N = Number of subjects with pre- and post-vaccination results available GMFR = Geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 182 reciprocal HI titer = 95% confidence interval, LL = Lower Limit, UL = Upper Limit Secondary Outcome Variable(s): Incidence of solicited local symptoms reported during the 7-day (Days 0-6) post-vaccination period following each dose and overall (Total Vaccinated cohort) Flu1-F1-2D Flu1-F2-2D 95 % CI 95 % CI Symptom Intensity 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 Redness Any >100 mm Swelling Any >100 mm Across doses Pain Any Grade Redness Any >100 mm Swelling Any >100 mm Flu1-F2-3D Flu2-2D 95 % CI N n % LL UL N n % LL UL Dose 1 Pain Any Redness Any >100 mm Swelling Any >100 mm Dose 2 Pain Any
10 Grade Redness Any >100 mm Swelling Any >100 mm Across doses Pain Any Grade Redness Any >100 mm Swelling Any >100 mm N= number of subjects with at least one 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 = incidence of a particular symptom regardless of intensity grade Grade 3 pain = pain that prevented normal activity Secondary Outcome Variable(s): Incidence of solicited local symptoms reported during the 7-day (Days 0-6) post-vaccination period following booster dose (Total Vaccinated cohort) Flu1-F1-2D Flu1-F2-2D 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL Pain Any Grade Redness Any >100 mm Swelling Any >100 mm Flu1-F2-3D Flu2-2D 95 % CI 95 % CI N n % LL UL N n % LL UL Pain Any Grade Redness Any >100 mm Swelling Any >100 mm 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 intensity grade Grade 3 pain = pain that prevented normal activity Secondary Outcome Variable(s): Incidence of solicited general symptoms reported during the 7-day (Days 0-6) postvaccination period following each dose and overall (Total Vaccinated cohort) Flu1-F1-2D Flu1-F2-2D Symptom Intensity/ Relationship 95 % CI 95 % CI N n % LL UL N n % LL UL Dose 1 Arthralgia Any Related Fatigue Any Related
11 Gastrointestinal Any Related Headache Any Related Myalgia Any Related Shivering Any Related Sweating Any Related Temperature/ (Axillary) 38.0 C C Related Dose 2 Arthralgia Any Related Fatigue Any Related Gastrointestinal Any Related Headache Any Grade Related Myalgia Any Related Shivering Any Related Sweating Any Related Temperature/ (Axillary) 38.0 C C Related Across doses Arthralgia Any Related Fatigue Any Related Gastrointestinal Any Related Headache Any
12 Grade Related Myalgia Any Related Shivering Any Related Sweating Any Related Temperature/ (Axillary) 38.0 C C Related Flu1-F2-3D Flu2-2D 95 % CI 95 % CI N n % LL UL N n % LL UL Dose 1 Arthralgia Any Related Fatigue Any Grade Related Gastrointestinal Any Related Headache Any Related Myalgia Any Related Shivering Any Related Sweating Any Related Temperature/ (Axillary) 38.0 C C Related Dose 2 Arthralgia Any Related Fatigue Any Related Gastrointestinal Any Grade Related Headache Any
13 Related Myalgia Any Related Shivering Any Related Sweating Any Related Temperature/ (Axillary) 38.0 C C Related Across doses Arthralgia Any Related Fatigue Any Grade Related Gastrointestinal Any Grade Related Headache Any Related Myalgia Any Related Shivering Any Related Sweating Any Related Temperature/ (Axillary) 38.0 C C Related N= number of subjects with at least one documented dose n/%= number/percentage of subjects reporting at least once the symptom Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination Grade 3 = symptom that prevented normal activity Related = symptom assessed by the investigator as related to the vaccination Secondary Outcome Variable(s): Incidence of solicited general symptoms reported during the 7-day (Days 0-6) postvaccination period following booster dose (Total vaccinated cohort) Flu1-F1-2D Flu1-F2-2D 95 % CI 95 % CI N n % LL UL N n % LL UL Symptom Intensity/ Relationship Arthralgia Any Grade Related Fatigue Any Grade
14 Related Gastrointestinal Any Grade Related Headache Any Grade Related Myalgia Any Grade Related Shivering Any Grade Related Sweating Any Grade Related Temperature/ (Axillary) 38.0 C C Related Flu1-F2-3D Flu2-2D 95 % CI 95 % CI N n % LL UL N n % LL UL Arthralgia Any Related Fatigue Any Related Gastrointestinal Any Related Headache Any Related Myalgia Any Related Shivering Any Related Sweating Any Related Temperature/ (Axillary) 38.0 C C Related N= number of subjects with the documented dose n/%= number/percentage of subjects reporting at least once the symptom Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination Grade 3 = symptom that prevented normal activity Related = symptom assessed by the investigator as related to the vaccination Secondary Outcome Variable(s): Percentage of subjects reporting the occurrence of unsolicited adverse events with medically attended visit, within the 42-day after the first vaccination or 21 days after the second vaccination (Total Vaccinated cohort)
15 MAEs (occurring within Days 0-41 following the first vaccination) Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D N = 68 Flu2-2D N = 110 Subjects with any MAE(s), n (%) 5 (7.6) 3 (4.5) 6 (8.8) 8 (7.3) Tonsillitis - 1 (1.5) 1 (1.5) 2 (1.8) Pharyngitis 1 (1.5) 1 (1.5) 1 (1.5) 1 (0.9) Gastritis (0.9) Bronchitis (0.9) Chronic tonsillitis (0.9) Arthralgia (0.9) Pain in extremity (0.9) Sinusitis 1 (1.5) 1 (1.5) 1 (1.5) - Injury 1 (1.5) - 1 (1.5) - Enteritis 1 (1.5) Cough 1 (1.5) Gingivitis (1.5) - Oral herpes (1.5) - - : Adverse event absent Secondary Outcome Variable(s): Percentage of subjects reporting the occurrence of unsolicited adverse events with medically attended visit through the entire study period (Days 0-364) (Total Vaccinated cohort) MAEs (occurring within Days following the first vaccination) Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D N = 68 Flu2-2D N = 110 Subjects with any MAE(s), n (%) 20 (30.3) 21(31.8) 22 (32.4) 34 (30.9) Enteritis 2 (3.0) Gastritis (7.4) 3 (2.7) Bronchitis - 3 (4.5) - 3 (2.7) Cystitis (4.4) - Laryngitis 2 (3.0) Nasopharyngitis 3 (4.5) 4 (6.1) 3 (4.4) - Pharyngitis 3 (4.5) 5 (7.6) 4 (5.9) 10 (9.1) Pharyngotonsillitis 2 (3.0) Rhinitis 3 (4.5) 4 (6.1) - - Tonsillitis 2 (3.0) 3 (4.5) 4 (5.9) 5 (4.5) Tracheitis 2 (3.0) Viral infection (4.5) Cough 2 (3.0) 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. Secondary Outcome Variable(s): Percentage of subjects reporting the occurrence of pimds up to 42 days after the first vaccination or 21 days after the second vaccination (Total Vaccinated cohort) pimds (occurring within Days 0-41 following the first vaccination) Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D N = 68 Flu2-2D N = 110 Subjects with any pimd(s), n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Secondary Outcome Variable(s): Percentage of subjects reporting the occurrence of pimds through the entire study period (Days 0-364) (Total Vaccinated cohort) pimds (occurring within Days following the first vaccination) Flu1-F1-2D Flu1-F2-2D Flu1-F2-3D N = 68 Flu2-2D N = 110 Subjects with any pimd(s), n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Secondary Outcome Variable(s): Distribution of hematology and biochemistry with respect to normal laboratory ranges (Total Vaccinated cohort)
16 Flu1-F1-2D Unknown Below Within Above Laboratory Timing N n % n % n % n % parameter ALAT PRE PI(D21) PII(D42) ASAT PRE PI(D21) PII(D42) total Bilirubin PRE PI(D21) PII(D42) Creatinine PRE PI(D21) PII(D42) Hematocrit PRE PI(D21) PII(D42) Hemoglobin PRE PI(D21) PII(D42) Platelets PRE PI(D21) PII(D42) BUN PRE PI(D21) PII(D42) White Blood Cells PRE PI(D21) PII(D42) Flu1-F2-2D Unknown Below Within Above N n % n % n % n % ALAT PRE PI(D21) PII(D42) ASAT PRE PI(D21) PII(D42) total Bilirubin PRE PI(D21) PII(D42) Creatinine PRE PI(D21) PII(D42) Hematocrit PRE PI(D21) PII(D42) Hemoglobin PRE PI(D21) PII(D42)
17 Platelets PRE PI(D21) PII(D42) BUN PRE PI(D21) PII(D42) White Blood Cells PRE PI(D21) PII(D42) Flu1-F2-3D N = 68 Unknown Below Within Above N n % n % n % n % ALAT PRE PI(D21) PII(D42) ASAT PRE PI(D21) PII(D42) total Bilirubin PRE PI(D21) PII(D42) Creatinine PRE PI(D21) PII(D42) Hematocrit PRE PI(D21) PII(D42) Hemoglobin PRE PI(D21) PII(D42) Platelets PRE PI(D21) PII(D42) BUN PRE PI(D21) PII(D42) White Blood Cells PRE PI(D21) PII(D42) Flu2-2D N = 110 Unknown Below Within Above N n % n % n % n % ALAT PRE PI(D21) PII(D42) ASAT PRE PI(D21) PII(D42) total Bilirubin PRE PI(D21) PII(D42) Creatinine PRE
18 PI(D21) PII(D42) Hematocrit PRE PI(D21) PII(D42) Hemoglobin PRE PI(D21) PII(D42) Platelets PRE PI(D21) PII(D42) BUN PRE PI(D21) PII(D42) White Blood Cells PRE PI(D21) PII(D42) N = number of subjects with laboratory results for the specified time point and laboratory parameter n/% = number/percentage of subjects in a given category Unknown = value unknown for the specified time point and laboratory parameter Below = value below the laboratory reference range defined for the specified time point and laboratory parameter Within = value within the laboratory reference range defined for the specified time point and laboratory parameter Above = value above the laboratory reference range defined for the specified time point and laboratory parameter ALAT = alanine aminotransferase ASAT = aspartate aminotransferase BUN = blood urea nitrogen PI(D21) = Post-vaccination Day 21 PII(D42) = Post-vaccination Day 42 PRE = Pre-vaccination Day 0 Secondary Outcome Variable(s): Distribution of hematology and biochemistry with respect to normal laboratory ranges (Total Vaccinated cohort) Flu1-F1-2D Unknown Below Within Above Laboratory Timing N n % n % n % n % parameter ALAT PRE PI(D21) PII(D42) PII(D182) PIII(D189) ASAT PRE PI(D21) PII(D42) PII(D182) PIII(D189) total Bilirubin PRE PI(D21) PII(D42) PII(D182) PIII(D189) Creatinine PRE PI(D21) PII(D42) PII(D182)
19 PIII(D189) Hematocrit PRE PI(D21) PII(D42) PII(D182) PIII(D189) Hemoglobin PRE PI(D21) PII(D42) PII(D182) PIII(D189) Platelets PRE PI(D21) PII(D42) PII(D182) PIII(D189) BUN PRE PI(D21) PII(D42) PII(D182) PIII(D189) White Blood Cells PRE PI(D21) PII(D42) PII(D182) PIII(D189) Flu1-F2-2D Unknown Below Within Above N n % n % n % n % ALAT PRE PI(D21) PII(D42) PII(D182) PIII(D189) ASAT PRE PI(D21) PII(D42) PII(D182) PIII(D189) total Bilirubin PRE PI(D21) PII(D42) PII(D182) PIII(D189) Creatinine PRE PI(D21) PII(D42) PII(D182) PIII(D189) Hematocrit PRE PI(D21) PII(D42) PII(D182)
20 PIII(D189) Hemoglobin PRE PI(D21) PII(D42) PII(D182) PIII(D189) Platelets PRE PI(D21) PII(D42) PII(D182) PIII(D189) BUN PRE PI(D21) PII(D42) PII(D182) PIII(D189) White Blood Cells PRE PI(D21) PII(D42) PII(D182) PIII(D189) Flu1-F2-3D N = 68 Unknown Below Within Above N n % n % n % n % ALAT PRE PI(D21) PII(D42) PII(D182) PIII(D189) ASAT PRE PI(D21) PII(D42) PII(D182) PIII(D189) total Bilirubin PRE PI(D21) PII(D42) PII(D182) PIII(D189) Creatinine PRE PI(D21) PII(D42) PII(D182) PIII(D189) Hematocrit PRE PI(D21) PII(D42) PII(D182) PIII(D189) Hemoglobin PRE PI(D21) PII(D42) PII(D182)
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