Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children (NCT NCT02207413)

NCT ID: NCT02207413

Last Updated: 2018-06-06

Results Overview

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. \>100mm.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1886 participants
• Primary outcome timeframe: During the 7-day (Days 0-6) post-vaccination period
• Results posted on: 2018-06-06

Participant Flow

Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season.

For 5 subjects, study vaccine dose not administered at all but subject number was allocated. Some data has been analysed in sub-groups by age: 3-4 years, 5-17 years, 6 months to <5 years.

Participant milestones

Measure	Influsplit Tetra_IP Adult Group Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_IP 3-17y Group Subjects in the Influsplit Tetra\_IP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_LP 3-17y Group Subjects in the Influsplit Tetra\_LP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_IP 6-35m Group Subjects in the Influsplit Tetra\_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).	Influsplit Tetra_LP 6-35m Group Subjects in the Influsplit Tetra\_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
Overall Study STARTED	60	60	410	411	466	474
Overall Study COMPLETED	59	60	410	410	459	461
Overall Study NOT COMPLETED	1	0	0	1	7	13

Reasons for withdrawal

Measure	Influsplit Tetra_IP Adult Group Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_IP 3-17y Group Subjects in the Influsplit Tetra\_IP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_LP 3-17y Group Subjects in the Influsplit Tetra\_LP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_IP 6-35m Group Subjects in the Influsplit Tetra\_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).	Influsplit Tetra_LP 6-35m Group Subjects in the Influsplit Tetra\_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
Overall Study Withdrawal by Subject	1	0	0	0	3	7
Overall Study Lost to Follow-up	0	0	0	1	1	5
Overall Study Adverse Event	0	0	0	0	2	1
Overall Study Migrated/moved from study area	0	0	0	0	1	0

Baseline Characteristics

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children

Baseline characteristics by cohort

Measure	Influsplit Tetra_IP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_IP 3-17y Group n=410 Participants Subjects in the Influsplit Tetra\_IP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_LP 3-17y Group n=411 Participants Subjects in the Influsplit Tetra\_LP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_IP 6-35m Group n=466 Participants Subjects in the Influsplit Tetra\_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).	Influsplit Tetra_LP 6-35m Group n=474 Participants Subjects in the Influsplit Tetra\_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).	Total n=1881 Participants Total of all reporting groups
Age, Continuous	NA Months STANDARD_DEVIATION NA • n=5 Participants	NA Months STANDARD_DEVIATION NA • n=7 Participants	NA Months STANDARD_DEVIATION NA • n=5 Participants	NA Months STANDARD_DEVIATION NA • n=4 Participants	19.7 Months STANDARD_DEVIATION 8.0 • n=21 Participants	19.9 Months STANDARD_DEVIATION 8.3 • n=10 Participants	19.8 Months STANDARD_DEVIATION 8.15 • n=115 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	35 Participants n=7 Participants	196 Participants n=5 Participants	187 Participants n=4 Participants	223 Participants n=21 Participants	209 Participants n=10 Participants	891 Participants n=115 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	25 Participants n=7 Participants	214 Participants n=5 Participants	224 Participants n=4 Participants	243 Participants n=21 Participants	265 Participants n=10 Participants	990 Participants n=115 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. >100mm.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=59 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). Any Pain	41 Subjects	32 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Pain	1 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). Any Redness	1 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Redness	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). Any Swelling	2 Subjects	4 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Swelling	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.

Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=59 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	32 Subjects	20 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	28 Subjects	20 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal symptoms	6 Subjects	6 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal symptoms	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal symptoms	4 Subjects	4 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache	30 Subjects	16 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	1 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache	26 Subjects	14 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Joint Pain	8 Subjects	5 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Joint Pain	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Joint Pain	8 Subjects	5 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia	21 Subjects	13 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia	1 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia	20 Subjects	13 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	9 Subjects	7 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	1 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	8 Subjects	6 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever	2 Subjects	2 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C)	2 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever	2 Subjects	2 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever	2 Subjects	1 Subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. N = Number of subjects with the symptom and without the missing confirmed grade

Duration was defined as number of days with any grade of local and general symptoms.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=41 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=32 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Joint Pain	1.0 Days Interval 1.0 to 4.0	3.0 Days Interval 1.0 to 4.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Fatigue	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Gastrointestinal symptoms	1.5 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 3.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Headache	1.0 Days Interval 1.0 to 6.0	1.5 Days Interval 1.0 to 5.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Myalgia	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Pain	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Redness	2.0 Days Interval 2.0 to 2.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Shivering	2.0 Days Interval 1.0 to 4.0	3.0 Days Interval 1.0 to 5.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Swelling	1.5 Days Interval 1.0 to 2.0	2.5 Days Interval 2.0 to 4.0
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. Fever	1.0 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.0

PRIMARY outcome

Timeframe: During the 3-day (Days 0-2) post-vaccination period

Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.

Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=59 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Chest Tightness	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Chest Tightness	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Chest Tightness	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Cough	3 Subjects	2 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Cough	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Cough	3 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Difficulty Breathing	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Difficulty Breathing	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Difficulty Breathing	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Hoarseness	1 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Hoarseness	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Hoarseness	1 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Red Eyes	1 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Red Eyes	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Red Eyes	1 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Sore Throat	4 Subjects	2 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Sore Throat	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Sore Throat	3 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swallowing Difficulty	3 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swallowing Difficulty	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swallowing Difficulty	2 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swelling of the face	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swelling of the face	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swelling of the face	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Wheezing	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Wheezing	0 Subjects	0 Subjects
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Wheezing	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the entire study period (approximately 21 days following vaccination)

Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. 1 subject withdrew consent in the Influsplit Tetra\_LP Adult Group and did not complete the study but was administered a study vaccine dose.

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). Any MAE(s)	9 Subjects	8 Subjects
Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). Grade 3 MAE(s)	3 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). Related MAE(s)	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. >50mm.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=410 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=410 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Swelling, Dose 2	1 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Pain, Across Doses	252 Subjects	264 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Pain, Across Doses	14 Subjects	21 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Redness, Across Doses	129 Subjects	128 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Redness, Across Doses	8 Subjects	7 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Swelling, Dose 2	16 Subjects	17 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Pain, Dose 2	0 Subjects	2 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Redness, Dose 2	25 Subjects	21 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Redness, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Pain, Dose 1	243 Subjects	253 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Pain, Dose 1	14 Subjects	20 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Redness, Dose 1	118 Subjects	119 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Redness, Dose 1	8 Subjects	7 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Swelling, Dose 1	102 Subjects	100 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Swelling, Dose 1	7 Subjects	7 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Pain, Dose 2	36 Subjects	39 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Any Swelling, Across Doses	109 Subjects	110 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). Grade 3 Swelling, Across Doses	8 Subjects	7 Subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.

Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=70 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=72 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Dose 1	4 Subjects	7 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 1	1 Subjects	3 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 1	1 Subjects	5 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Dose 1	1 Subjects	5 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Dose 2	5 Subjects	6 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Dose 2	3 Subjects	4 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Dose 2	2 Subjects	8 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Dose 2	2 Subjects	6 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite, Dose 2	4 Subjects	6 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss of appetite, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite, Dose 2	2 Subjects	3 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 2	0 Subjects	4 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Dose 2]	0 Subjects	3 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 2	0 Subjects	2 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Across Doses	16 Subjects	11 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Across Doses	0 Subjects	2 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Across Doses	10 Subjects	8 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Across Doses	10 Subjects	16 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability ,Across Doses	1 Subjects	1 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Across Doses	7 Subjects	11 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite,Across Doses	13 Subjects	16 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss of appetite, Across Doses	2 Subjects	1 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite, Across Doses	8 Subjects	8 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Across Doses	5 Subjects	10 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Across Doses	4 Subjects	9 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Across Doses	1 Subjects	3 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Across Doses	1 Subjects	6 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Across Doses	1 Subjects	5 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Dose 1	14 Subjects	7 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Dose 1	0 Subjects	1 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Dose 1	10 Subjects	4 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Dose 1	9 Subjects	12 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Dose 1	1 Subjects	1 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Dose 1	6 Subjects	8 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite, Dose 1	9 Subjects	14 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss of appetite, Dose 1	2 Subjects	1 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite, Dose 1	6 Subjects	6 Subjects
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 1	5 Subjects	7 Subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=340 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=338 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue, Dose 1	94 Subjects	99 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue, Dose 1	8 Subjects	13 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue, Dose 1	65 Subjects	70 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal, Dose 1	35 Subjects	32 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal, Dose 1	2 Subjects	1 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal, Dose 1	18 Subjects	16 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache, Dose 1	82 Subjects	76 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache, Dose 1	3 Subjects	9 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache, Dose 1	46 Subjects	50 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Joint Pain, Dose 1	34 Subjects	38 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Joint Pain, Dose 1	3 Subjects	2 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Joint Pain, Dose 1	25 Subjects	29 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia, Dose 1	70 Subjects	84 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia, Dose 1	3 Subjects	5 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia, Dose 1	55 Subjects	72 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering, Dose 1	20 Subjects	29 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering, Dose 1	0 Subjects	3 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Shivering, Dose 1	16 Subjects	20 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 1	12 Subjects	9 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Dose 1	11 Subjects	8 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 1	10 Subjects	7 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Dose 1	9 Subjects	6 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue, Dose 2	8 Subjects	4 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue, Dose 2	4 Subjects	4 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal, Dose 2	3 Subjects	1 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache, Dose 2	2 Subjects	7 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache, Dose 2	2 Subjects	4 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Joint Pain, Dose 2	2 Subjects	4 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Joint Pain, Dose 2	1 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Joint Pain, Dose 2	1 Subjects	3 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia, Dose 2	3 Subjects	9 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia, Dose 2	1 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia, Dose 2	2 Subjects	7 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering, Dose 2	2 Subjects	2 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Shivering, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 2	3 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Dose 2	2 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 2	1 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 2	2 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Dose 2	1 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue, Across Doses	97 Subjects	101 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue, Across Doses	8 Subjects	13 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue, Across Doses	66 Subjects	72 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal, Across Doses	38 Subjects	32 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal, Across Doses	2 Subjects	1 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal, Across Doses	18 Subjects	16 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache, Across Doses	83 Subjects	80 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache, Across Doses	3 Subjects	9 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache, Across Doses	48 Subjects	53 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Joint Pain, Across Doses	35 Subjects	42 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Joint Pain, Across Doses	4 Subjects	2 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Joint Pain, Across Doses	25 Subjects	32 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia, Across Doses	71 Subjects	88 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia, Across Doses	4 Subjects	5 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia, Across Doses	56 Subjects	76 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering, Across Doses	21 Subjects	31 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering, Across Doses	0 Subjects	3 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Shivering, Across Doses	16 Subjects	21 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Across Doses	14 Subjects	9 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Across Doses	12 Subjects	8 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Across Doses	1 Subjects	0 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Across Doses	12 Subjects	7 Subjects
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Across Doses	10 Subjects	6 Subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.

Duration was defined as number of days with any grade of local symptoms.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=243 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=253 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Duration of Solicited Local AEs in Subjects Aged 3-17 Years. Pain, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited Local AEs in Subjects Aged 3-17 Years. Pain, Dose 2	1.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited Local AEs in Subjects Aged 3-17 Years. Redness, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited Local AEs in Subjects Aged 3-17 Years. Redness, Dose 2	2.0 Days Interval 1.0 to 5.0	1.0 Days Interval 1.0 to 7.0
Duration of Solicited Local AEs in Subjects Aged 3-17 Years. Swelling, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited Local AEs in Subjects Aged 3-17 Years. Swelling, Dose 2	2.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 7.0

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=14 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=14 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Drowsiness, Dose 1	1.0 Days Interval 1.0 to 6.0	1.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Drowsiness, Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Irritability, Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 4.0
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Irritability, Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Loss of appetite, Dose 1	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Loss of appetite, Dose 2	1.0 Days Interval 1.0 to 2.0	4.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Fever, Dose 1	2.0 Days Interval 1.0 to 5.0	1.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs in Subjects Aged 3-4 Years. Fever, Dose 2	NA Days No subjects with symptom and without the missing confirmed grade were reported in this group.	1.5 Days Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=94 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=99 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Fatigue, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Fatigue, Dose 2	1.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 3.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Gastrointestinal symptoms, Dose 1	1.0 Days Interval 1.0 to 6.0	1.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Gastrointestinal symptoms, Dose 2	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Headache, Dose 1	1.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Headache, Dose 2	2.5 Days Interval 2.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Joint Pain, Dose 1	2.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Joint Pain, Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Myalgia, Dose 1	2.0 Days Interval 1.0 to 5.0	1.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Myalgia, Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Shivering, Dose 1	1.0 Days Interval 1.0 to 6.0	1.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Shivering, Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Fever, Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 6.0
Duration of Solicited General AEs in Subjects Aged 5-17 Years. Fever, Dose 2	2.0 Days Interval 1.0 to 2.0	NA Days No subjects with symptom and without the missing confirmed grade were reported in this group.

PRIMARY outcome

Timeframe: During the 3-day (Days 0-2) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.

Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling.

Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=410 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=410 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Hoarseness, Dose 1	2 Subjects	6 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Red Eyes, Dose 1	14 Subjects	12 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Chest Tightness, Dose 1	2 Subjects	6 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Chest Tightness, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Chest Tightness, Dose 1	0 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Cough, Dose 1	35 Subjects	31 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Cough, Dose 1	2 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Cough, Dose 1	12 Subjects	10 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Difficulty Breathing, Dose 1	5 Subjects	11 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Difficulty Breathing, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Difficulty Breathing, Dose 1	2 Subjects	7 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Hoarseness, Dose 1	10 Subjects	12 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Hoarseness, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Red Eyes, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Red Eyes, Dose 1	6 Subjects	9 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Sore throat, Dose 1	14 Subjects	18 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Sore throat, Dose 1	1 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Sore throat, Dose 1	2 Subjects	9 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swallowing Difficulty, Dose 1	5 Subjects	6 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swallowing Difficulty, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swallowing Difficulty, Dose 1	1 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swelling of the face, Dose 1	3 Subjects	2 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swelling of the face, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swelling of the face, Dose 1	3 Subjects	2 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Wheezing, Dose 1	1 Subjects	5 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Wheezing, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Wheezing, Dose 1	1 Subjects	4 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Chest Tightness, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Chest Tightness, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Chest Tightness, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Cough, Dose 2	6 Subjects	13 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Cough, Dose 2	0 Subjects	2 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Cough, Dose 2	1 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Difficulty Breathing, Dose 2	0 Subjects	2 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Difficulty Breathing, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Difficulty Breathing, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Hoarseness, Dose 2	2 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Hoarseness, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Hoarseness, Dose 2	1 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Red Eyes, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Red Eyes, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Red Eyes, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Sore Throat, Dose 2	2 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Sore Throat, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Sore Throat, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swallowing Difficulty, Dose 2	2 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swallowing Difficulty, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swallowing Difficulty, Dose 2	1 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swelling of the face, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swelling of the face, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swelling of the face, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Wheezing, Dose 2	0 Subjects	2 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Wheezing, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Wheezing, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Chest Tightness, Across Doses	2 Subjects	6 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Chest Tightness, Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Chest Tightness, Across Doses	0 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Cough, Across Doses	39 Subjects	39 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Cough, Across Doses	2 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Cough, Across Doses	13 Subjects	11 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Difficulty Breathing, Across Doses	5 Subjects	13 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Difficulty Breathing, Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Difficulty Breathing, Across Doses	2 Subjects	7 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Hoarseness, Across Doses	11 Subjects	15 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Hoarseness, Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Hoarseness, Across Doses	3 Subjects	6 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Red Eyes, Across Doses	14 Subjects	13 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Red Eyes, Across Doses	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Red Eyes, Across Doses	6 Subjects	10 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Sore Throat, Across Doses	15 Subjects	21 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Sore Throat, Across Doses	1 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Sore Throat, Across Doses	2 Subjects	9 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swallowing Difficulty, Across Doses	6 Subjects	7 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swallowing Difficulty, Across Doses	0 Subjects	1 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swallowing Difficulty, Across Doses	2 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swelling of the face, Across Doses	3 Subjects	3 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swelling of the face, Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swelling of the face, Across Doses	3 Subjects	2 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Wheezing, Across Doses	1 Subjects	7 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Wheezing, Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Wheezing, Across Doses	1 Subjects	4 Subjects

PRIMARY outcome

Timeframe: During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=410 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=411 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . Any MAE(s)	59 Subjects	52 Subjects
Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . Grade 3 MAE(s)	7 Subjects	6 Subjects
Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . Related MAE(s)	2 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up period after vaccination

Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any Unsolicited AEs	14 Subjects	14 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 Unsolicited AEs	3 Subjects	2 Subjects
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related Unsolicited AEs	2 Subjects	1 Subjects

PRIMARY outcome

Timeframe: During the 28-day (Days 0-27) follow-up period after vaccination

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to 17 years, with at least one vaccine administration documented.

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=410 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=411 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Any Unsolicited AEs	83 Subjects	86 Subjects
Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Grade 3 Unsolicited AEs	12 Subjects	8 Subjects
Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Related Unsolicited AEs	10 Subjects	7 Subjects

PRIMARY outcome

Timeframe: During 7 days (Days 0-6) post-vaccination

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=462 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=470 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. Any Fever	76 Subjects	70 Subjects
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. Fever (≥38°C)	72 Subjects	69 Subjects

PRIMARY outcome

Timeframe: During the entire study period (approximately 21 days)

Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.

A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=60 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) Any SAEs	1 Subjects	1 Subjects
Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.

A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=410 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=411 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) Any SAEs	1 Subjects	0 Subjects
Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: At Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=403 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=402 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. H1N1	698.0 Titers Interval 629.6 to 773.9	694.1 Titers Interval 625.8 to 769.7
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. H3N2	158.2 Titers Interval 143.7 to 174.2	171.4 Titers Interval 156.3 to 188.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. Yamagata	479.0 Titers Interval 434.1 to 528.5	527.6 Titers Interval 475.5 to 585.3
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. Victoria	237.6 Titers Interval 210.4 to 268.3	253.7 Titers Interval 222.7 to 289.1

PRIMARY outcome

Timeframe: At Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 to 35 months, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=432 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=427 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. H1N1	97.5 Titers Interval 82.1 to 115.7	105.5 Titers Interval 88.2 to 126.1
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. H3N2	45.2 Titers Interval 39.0 to 52.3	59.9 Titers Interval 51.7 to 69.4
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. Yamagata	100.8 Titers Interval 87.8 to 115.8	105.4 Titers Interval 91.8 to 121.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. Victoria	32.1 Titers Interval 28.1 to 36.7	38.0 Titers Interval 33.2 to 43.5

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.

HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=57 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=58 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H1N1, Day 0]	48.3 Titers Interval 33.4 to 69.7	53.6 Titers Interval 36.8 to 78.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H1N1, Day 21]	655.7 Titers Interval 493.1 to 871.9	632.2 Titers Interval 498.8 to 801.3
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H3N2, Day 0]	16.7 Titers Interval 12.6 to 22.2	16.0 Titers Interval 11.9 to 21.5
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H3N2, Day 21	80.5 Titers Interval 63.2 to 102.7	73.0 Titers Interval 59.0 to 90.5
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Yamagata, Day 0]	133.3 Titers Interval 98.4 to 180.6	101.6 Titers Interval 76.2 to 135.4
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Yamagata, Day 21]	591.4 Titers Interval 475.1 to 736.3	598.6 Titers Interval 480.9 to 745.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Victoria, Day 0]	38.6 Titers Interval 29.5 to 50.5	34.8 Titers Interval 25.2 to 48.1
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Victoria, Day 21]	263.4 Titers Interval 209.0 to 331.9	302.9 Titers Interval 244.0 to 376.1

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.

A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=57 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=57 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H1N1	42 Subjects	42 Subjects
Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H3N2	30 Subjects	29 Subjects
Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Yamagata	27 Subjects	36 Subjects
Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Victoria	36 Subjects	40 Subjects

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.

The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=57 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=58 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H1N1, Day 0]	35 Subjects	35 Subjects
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H1N1, Day 21]	56 Subjects	57 Subjects
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H3N2, Day 0]	15 Subjects	14 Subjects
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H3N2, Day 21]	49 Subjects	49 Subjects
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Yamagata, Day 0]	52 Subjects	50 Subjects
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Yamagata, Day 21]	57 Subjects	57 Subjects
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Victoria, Day 0]	34 Subjects	32 Subjects
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Victoria, Day 21]	57 Subjects	57 Subjects

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.

MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0).

The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=57 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=57 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. H1N1	13.6 Fold increase Interval 8.9 to 20.8	11.5 Fold increase Interval 7.7 to 17.0
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. H3N2	4.8 Fold increase Interval 3.6 to 6.5	4.6 Fold increase Interval 3.6 to 5.7
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. Yamagata	4.4 Fold increase Interval 3.3 to 6.0	6.0 Fold increase Interval 4.3 to 8.2
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. Victoria	6.8 Fold increase Interval 5.0 to 9.2	8.6 Fold increase Interval 6.0 to 12.3

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.

Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=340 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=338 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses.	71 Subjects	88 Subjects

SECONDARY outcome

Timeframe: At Day 0 and Day 28 post last vaccination

Population: The analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were avail

HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=403 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=402 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H1N1, Day 0]	80.2 Titers Interval 69.2 to 93.0	87.7 Titers Interval 76.1 to 101.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H1N1, Day 28]	698.0 Titers Interval 629.6 to 773.9	694.1 Titers Interval 625.8 to 769.7
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H3N2, Day 0]	38.9 Titers Interval 34.6 to 43.8	41.9 Titers Interval 37.1 to 47.3
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [H3N2, Day 28]	158.2 Titers Interval 143.7 to 174.2	171.4 Titers Interval 156.3 to 188.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Yamagata, Day 0]	58.1 Titers Interval 49.7 to 68.0	70.8 Titers Interval 60.4 to 83.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Yamagata, Day 28]	479.0 Titers Interval 434.1 to 528.5	527.6 Titers Interval 475.5 to 585.3
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Victoria, Day 0]	27.3 Titers Interval 23.8 to 31.3	28.8 Titers Interval 25.0 to 33.1
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [Victoria, Day 28]	237.6 Titers Interval 210.4 to 268.3	253.7 Titers Interval 222.7 to 289.1

SECONDARY outcome

Timeframe: At Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=403 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=402 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H1N1	274 Subjects	269 Subjects
Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H3N2	192 Subjects	183 Subjects
Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Yamagata	273 Subjects	268 Subjects
Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Victoria	285 Subjects	287 Subjects

SECONDARY outcome

Timeframe: At Day 0 and Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=403 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=402 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H1N1, Day 0]	308 Subjects	314 Subjects
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H1N1, Day 28]	393 Subjects	395 Subjects
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H3N2, Day 0]	245 Subjects	252 Subjects
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H3N2, Day 28]	377 Subjects	378 Subjects
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Yamagata, Day 0]	266 Subjects	281 Subjects
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Yamagata, Day 28]	396 Subjects	395 Subjects
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Victoria, Day 0]	192 Subjects	195 Subjects
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Victoria, Day 28]	375 Subjects	374 Subjects

SECONDARY outcome

Timeframe: At Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=403 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=402 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. H1N1	8.7 Fold increase Interval 7.6 to 10.0	7.9 Fold increase Interval 6.9 to 9.1
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. H3N2	4.1 Fold increase Interval 3.7 to 4.5	4.1 Fold increase Interval 3.7 to 4.6
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. Yamagata	8.2 Fold increase Interval 7.2 to 9.4	7.4 Fold increase Interval 6.5 to 8.5
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. Victoria	8.7 Fold increase Interval 7.7 to 9.8	8.8 Fold increase Interval 7.7 to 10.0

SECONDARY outcome

Timeframe: At Day 0 and Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=432 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=427 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains Victoria, Day 0	5.7 Titers Interval 5.4 to 6.1	5.7 Titers Interval 5.4 to 6.1
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains H1N1, Day 0	11.1 Titers Interval 9.6 to 12.8	11.2 Titers Interval 9.7 to 12.9
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains H1N1, Day 28	97.5 Titers Interval 82.1 to 115.7	105.5 Titers Interval 88.2 to 126.1
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains H3N2, Day 0	7.5 Titers Interval 6.8 to 8.2	8.4 Titers Interval 7.5 to 9.3
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains H3N2, Day 28	45.2 Titers Interval 39.0 to 52.3	59.9 Titers Interval 51.7 to 69.4
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains Yamagata, Day 0	8.3 Titers Interval 7.5 to 9.1	7.9 Titers Interval 7.2 to 8.6
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains Yamagata, Day 28	100.8 Titers Interval 87.8 to 115.8	105.4 Titers Interval 91.8 to 121.0
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains Victoria, Day 28	32.1 Titers Interval 28.1 to 36.7	38.0 Titers Interval 33.2 to 43.5

SECONDARY outcome

Timeframe: At Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=432 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=427 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H1N1	287 Subjects	275 Subjects
Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H3N2	217 Subjects	236 Subjects
Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Yamagata	318 Subjects	321 Subjects
Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Victoria	213 Subjects	211 Subjects

SECONDARY outcome

Timeframe: At Day 0 and Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=432 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=427 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H1N1, Day 0	84 Subjects	83 Subjects
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H1N1, Day 28	303 Subjects	289 Subjects
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H3N2, Day 0	55 Subjects	67 Subjects
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. H3N2, Day 28	232 Subjects	259 Subjects
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Yamagata, Day 0	53 Subjects	49 Subjects
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Yamagata, Day 28	329 Subjects	331 Subjects
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Victoria, Day 0	17 Subjects	16 Subjects
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Victoria, Day 28	214 Subjects	217 Subjects

SECONDARY outcome

Timeframe: At Day 28 post last vaccination

Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available

MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=432 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=427 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. H1N1	8.8 Fold increase Interval 7.8 to 10.0	9.5 Fold increase Interval 8.3 to 10.8
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. H3N2	6.0 Fold increase Interval 5.4 to 6.8	7.1 Fold increase Interval 6.3 to 7.9
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. Yamagata	12.2 Fold increase Interval 10.8 to 13.8	13.3 Fold increase Interval 11.8 to 15.0
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. Victoria	5.6 Fold increase Interval 5.0 to 6.3	6.6 Fold increase Interval 5.8 to 7.4

SECONDARY outcome

Timeframe: During 7 days (Days 0-6) post-vaccination

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.

Fever = temperature of ≥ 38°C/100.4°F by any route

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=462 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=470 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. Any Fever, Dose 1	42 Subjects	44 Subjects
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. Fever (≥38°C), Dose 1	39 Subjects	42 Subjects
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. Any Fever, Dose 2	41 Subjects	40 Subjects
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. Fever (≥38°C), Dose 2	40 Subjects	40 Subjects

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 50mm.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=462 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=470 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Pain, Dose 1	69 Subjects	77 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Pain, Dose 1	1 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Redness, Dose 1	88 Subjects	86 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Redness, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Swelling, Dose 1	33 Subjects	42 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Swelling, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Pain, Dose 2	47 Subjects	48 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Pain, Dose 2	1 Subjects	4 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Redness, Dose 2	61 Subjects	66 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Redness, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Swelling, Dose 2	32 Subjects	27 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Swelling, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Pain, Across Doses	89 Subjects	98 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Pain, Across Doses	2 Subjects	4 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Redness, Across Doses	106 Subjects	106 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Redness, Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Any Swelling, Across Doses	50 Subjects	51 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). Grade 3 Swelling, Across Doses	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: During the 2 days (Day 0-Day 1) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to \<5 years, with at least one vaccine administration documented.

Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF.

Data of 2 independent groups were pooled.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=532 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=542 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. Any Fever	29 Subjects	31 Subjects
Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. Fever (≥38°C)	28 Subjects	31 Subjects
Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. Grade 3 Fever	4 Subjects	1 Subjects

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>)39.0°C.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=462 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=470 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Dose 1	87 Subjects	77 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Dose 1	3 Subjects	7 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Dose 1	54 Subjects	50 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Dose 1	124 Subjects	96 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Dose 1	10 Subjects	10 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Dose 1	75 Subjects	58 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite, Dose 1	94 Subjects	76 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss of appetite, Dose 1	9 Subjects	8 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite, Dose 1	47 Subjects	40 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 1	42 Subjects	44 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Dose 1	39 Subjects	42 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 1	8 Subjects	5 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 1	16 Subjects	23 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Dose 1	14 Subjects	22 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Dose 2	63 Subjects	58 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Dose 2	6 Subjects	7 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Dose 2	46 Subjects	35 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Dose 2	87 Subjects	87 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Dose 2	5 Subjects	8 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Dose 2	59 Subjects	50 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss Of Appetite, Dose 2	64 Subjects	69 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss Of Appetite, Dose 2	4 Subjects	10 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss Of Appetite, Dose 2	39 Subjects	37 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 2	41 Subjects	40 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Dose 2	40 Subjects	40 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 2	10 Subjects	9 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 2	19 Subjects	17 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Dose 2	19 Subjects	17 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Across Doses	115 Subjects	103 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Across Doses	8 Subjects	13 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Across Doses	78 Subjects	66 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Across Doses	155 Subjects	141 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Across Doses	15 Subjects	17 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Across Doses	98 Subjects	87 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss Of Appetite, Across Doses	127 Subjects	116 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss Of Appetite, Across Doses	13 Subjects	17 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss Of Appetite, Across Doses	69 Subjects	61 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Across Doses	76 Subjects	70 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Fever (≥38.0°C), Across Doses	72 Subjects	69 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Across Doses	18 Subjects	14 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Across Doses	32 Subjects	35 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. ≥38.0°C Related Fever, Across Doses	30 Subjects	34 Subjects

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

Duration was defined as number of days with any grade of local symptoms.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=88 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=86 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Duration of Solicited Local AEs in Subjects Aged 6-35 Months. Pain, Dose 1	1.0 Days Interval 1.0 to 6.0	1.0 Days Interval 1.0 to 7.0
Duration of Solicited Local AEs in Subjects Aged 6-35 Months. Pain, Dose 2	2.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited Local AEs in Subjects Aged 6-35 Months. Redness, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited Local AEs in Subjects Aged 6-35 Months. Redness, Dose 2	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited Local AEs in Subjects Aged 6-35 Months. Swelling, Dose 1	1.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 7.0
Duration of Solicited Local AEs in Subjects Aged 6-35 Months. Swelling, Dose 2	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=124 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=96 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Loss of appetite, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Drowsiness, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Drowsiness, Dose 2	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Irritability, Dose 1	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Irritability, Dose 2	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Loss of appetite, Dose 2	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Fever, Dose 1	2.0 Days Interval 1.0 to 5.0	1.0 Days Interval 1.0 to 4.0
Duration of Solicited General AEs in Subjects Aged 6-35 Months. Fever, Dose 2	1.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: During a 3 day (Days 0-2) follow-up period after vaccination

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=462 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=470 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Red Eyes, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Red Eyes, Dose 2	6 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Sore Throat, Dose 2	7 Subjects	11 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Sore Throat, Dose 2	1 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Hoarseness, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Hoarseness, Dose 2	1 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Red Eyes, Dose 2	10 Subjects	11 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Chest Tightness, Dose 1	2 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Chest Tightness, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Chest Tightness, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Cough, Dose 1	47 Subjects	50 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Cough, Dose 1	3 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Cough, Dose 1	16 Subjects	13 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Difficulty Breathing, Dose 1	15 Subjects	12 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Difficulty Breathing, Dose 1	1 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Difficulty Breathing, Dose 1	4 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Hoarseness, Dose 1	13 Subjects	11 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Hoarseness, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Hoarseness, Dose 1	1 Subjects	4 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Red Eyes, Dose 1	10 Subjects	11 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Red Eyes, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Red Eyes, Dose 1	6 Subjects	5 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Sore throat, Dose 1	6 Subjects	7 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Sore throat, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Sore throat, Dose 1	1 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swallowing Difficulty, Dose 1	1 Subjects	5 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swallowing Difficulty, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swallowing Difficulty, Dose 1	0 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swelling of the face, Dose 1	4 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swelling of the face, Dose 1	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swelling of the face, Dose 1	1 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Wheezing, Dose 1	9 Subjects	12 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Wheezing, Dose 1	1 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Wheezing, Dose 1	3 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Chest Tightness, Dose 2	9 Subjects	4 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Chest Tightness, Dose 2	0 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Chest Tightness, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Cough, Dose 2	37 Subjects	53 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Cough, Dose 2	5 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Cough, Dose 2	8 Subjects	8 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Difficulty Breathing, Dose 2	19 Subjects	18 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Difficulty Breathing, Dose 2	1 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Difficulty Breathing, Dose 2	5 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Hoarseness, Dose 2	13 Subjects	9 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Sore Throat, Dose 2	0 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swallowing Difficulty, Dose 2	8 Subjects	7 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swallowing Difficulty, Dose 2	2 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swallowing Difficulty, Dose 2	0 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swelling of the face, Dose 2	5 Subjects	4 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swelling of the face, Dose 2	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swelling of the face, Dose 2	1 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Wheezing, Dose 2	11 Subjects	16 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Wheezing, Dose 2	3 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Wheezing, Dose 2	4 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Chest Tightness, Across Doses	10 Subjects	5 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Chest Tightness, Across Doses	0 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Chest Tightness, Across Doses	0 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Cough, Across Doses	73 Subjects	85 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Cough, Across Doses	8 Subjects	6 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Cough, Across Doses	22 Subjects	18 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Difficulty Breathing, Across Doses	31 Subjects	25 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Difficulty Breathing, Across Doses	2 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Difficulty Breathing, Across Doses	8 Subjects	4 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Hoarseness, Across Doses	23 Subjects	17 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Hoarseness, Across Doses	0 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Hoarseness, Across Doses	2 Subjects	5 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Red Eyes, Across Doses	18 Subjects	19 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Red Eyes, Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Red Eyes, Across Doses	10 Subjects	5 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Sore Throat, Across Doses	12 Subjects	17 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Sore Throat, Across Doses	1 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Sore Throat, Across Doses	1 Subjects	5 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swallowing Difficulty, Across Doses	8 Subjects	12 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swallowing Difficulty, Across Doses	2 Subjects	1 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swallowing Difficulty, Across Doses	0 Subjects	3 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Swelling of the face, Across Doses	9 Subjects	7 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Swelling of the face,Across Doses	0 Subjects	0 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Swelling of the face,Across Doses	2 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Any Wheezing, Across Doses	19 Subjects	26 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Grade 3 Wheezing, Across Doses	4 Subjects	2 Subjects
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. Related Wheezing, Across Doses	7 Subjects	5 Subjects

SECONDARY outcome

Timeframe: During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=466 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=474 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) Any MAE(s)	235 Subjects	252 Subjects
Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) Grade 3 MAE(s)	35 Subjects	29 Subjects
Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) Related MAE(s)	2 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the 28-day (Days 0-27) follow-up period after vaccination

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=466 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=474 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Any Unsolicited AEs	243 Subjects	262 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Grade 3 Unsolicited AEs	33 Subjects	31 Subjects
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Related Unsolicited AEs	6 Subjects	3 Subjects

SECONDARY outcome

Timeframe: During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]

Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.

A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Influsplit Tetra_IP Adult Group n=466 Participants Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=474 Participants Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) Any SAEs	7 Subjects	11 Subjects
Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Subjects	0 Subjects

Adverse Events

Influsplit Tetra_IP Adult Group

Serious events: 1 serious events

Other events: 51 other events

Deaths: 0 deaths

Influsplit Tetra_LP Adult Group

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Influsplit Tetra_IP 3-17 y

Serious events: 1 serious events

Other events: 327 other events

Deaths: 0 deaths

Influsplit Tetra_LP 3-17 y

Serious events: 0 serious events

Other events: 324 other events

Deaths: 0 deaths

Influsplit Tetra_IP 6-35 m

Serious events: 7 serious events

Other events: 315 other events

Deaths: 0 deaths

Influsplit Tetra_LP 6-35 m

Serious events: 11 serious events

Other events: 319 other events

Deaths: 0 deaths

Serious adverse events

Measure	Influsplit Tetra_IP Adult Group n=60 participants at risk Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=60 participants at risk Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_IP 3-17 y n=410 participants at risk Subjects in the Influsplit Tetra\_IP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_LP 3-17 y n=411 participants at risk Subjects in the Influsplit Tetra\_LP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_IP 6-35 m n=466 participants at risk Subjects in the Influsplit Tetra\_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).	Influsplit Tetra_LP 6-35 m n=474 participants at risk Subjects in the Influsplit Tetra\_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	1.7% 1/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Meningitis viral	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.24% 1/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Gastroenteritis	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.64% 3/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.42% 2/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Bronchitis	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.43% 2/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.42% 2/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Bronchiolitis	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.42% 2/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Adenovirus infection	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Bronchopneumonia	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Metabolism and nutrition disorders Dehydration	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Epstein-Barr virus infection	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Nervous system disorders Febrile convulsion	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Haemophilus infection	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Otitis media	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Pseudocroup	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Upper respiratory tract infection	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Viral infection	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.

Other adverse events

Measure	Influsplit Tetra_IP Adult Group n=60 participants at risk Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_LP Adult Group n=60 participants at risk Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.	Influsplit Tetra_IP 3-17 y n=410 participants at risk Subjects in the Influsplit Tetra\_IP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_LP 3-17 y n=411 participants at risk Subjects in the Influsplit Tetra\_LP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).	Influsplit Tetra_IP 6-35 m n=466 participants at risk Subjects in the Influsplit Tetra\_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).	Influsplit Tetra_LP 6-35 m n=474 participants at risk Subjects in the Influsplit Tetra\_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 8/60 • Number of events 8 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	8.3% 5/60 • Number of events 5 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	8.5% 35/410 • Number of events 36 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	10.2% 42/411 • Number of events 43 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Bronchitis	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	1.2% 5/410 • Number of events 5 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.97% 4/411 • Number of events 4 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	8.4% 39/466 • Number of events 49 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	11.8% 56/474 • Number of events 64 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
General disorders Chills	15.0% 9/60 • Number of events 9 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	11.7% 7/60 • Number of events 7 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.1% 21/410 • Number of events 22 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	7.5% 31/411 • Number of events 31 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/466 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 3/60 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.3% 2/60 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	10.5% 43/410 • Number of events 46 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	10.7% 44/411 • Number of events 51 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	18.5% 86/466 • Number of events 99 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	21.1% 100/474 • Number of events 124 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.2% 13/410 • Number of events 13 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.9% 16/411 • Number of events 20 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	27.3% 127/466 • Number of events 158 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	24.5% 116/474 • Number of events 145 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	1.5% 6/410 • Number of events 6 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.2% 13/411 • Number of events 13 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	6.7% 31/466 • Number of events 34 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.3% 25/474 • Number of events 30 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	32.0% 131/410 • Number of events 145 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	31.1% 128/411 • Number of events 140 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	22.7% 106/466 • Number of events 149 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	22.6% 107/474 • Number of events 153 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
General disorders Fatigue	53.3% 32/60 • Number of events 32 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	33.3% 20/60 • Number of events 20 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	23.7% 97/410 • Number of events 102 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	24.6% 101/411 • Number of events 103 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Gastroenteritis	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.49% 2/410 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.97% 4/411 • Number of events 4 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	6.7% 31/466 • Number of events 33 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	7.8% 37/474 • Number of events 44 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Gastrointestinal disorders Gastrointestinal disorder	10.0% 6/60 • Number of events 6 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	10.0% 6/60 • Number of events 6 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	9.3% 38/410 • Number of events 38 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	7.8% 32/411 • Number of events 33 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Nervous system disorders Headache	51.7% 31/60 • Number of events 32 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	26.7% 16/60 • Number of events 17 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	20.7% 85/410 • Number of events 89 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	20.4% 84/411 • Number of events 88 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.21% 1/474 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Psychiatric disorders Irritability	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	2.4% 10/410 • Number of events 11 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.9% 16/411 • Number of events 20 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	33.3% 155/466 • Number of events 211 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	29.7% 141/474 • Number of events 183 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Musculoskeletal and connective tissue disorders Myalgia	35.0% 21/60 • Number of events 21 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	21.7% 13/60 • Number of events 13 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	17.6% 72/410 • Number of events 74 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	21.9% 90/411 • Number of events 96 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Nasopharyngitis	1.7% 1/60 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	6.7% 4/60 • Number of events 4 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.98% 4/410 • Number of events 4 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	1.5% 6/411 • Number of events 6 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.6% 26/466 • Number of events 27 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	6.1% 29/474 • Number of events 30 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 4/60 • Number of events 4 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.0% 3/60 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.9% 16/410 • Number of events 17 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.6% 23/411 • Number of events 23 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	2.8% 13/466 • Number of events 14 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.8% 18/474 • Number of events 20 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
General disorders Pain	68.3% 41/60 • Number of events 41 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	53.3% 32/60 • Number of events 32 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	61.5% 252/410 • Number of events 279 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	64.2% 264/411 • Number of events 294 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	19.1% 89/466 • Number of events 117 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	20.7% 98/474 • Number of events 125 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
General disorders Pyrexia	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.1% 21/410 • Number of events 22 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.8% 24/411 • Number of events 25 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	20.4% 95/466 • Number of events 112 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	19.4% 92/474 • Number of events 111 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Nervous system disorders Somnolence	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.9% 16/410 • Number of events 19 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	2.7% 11/411 • Number of events 13 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	24.7% 115/466 • Number of events 150 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	21.7% 103/474 • Number of events 135 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
General disorders Swelling	3.3% 2/60 • Number of events 2 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	6.7% 4/60 • Number of events 4 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	26.6% 109/410 • Number of events 118 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	26.8% 110/411 • Number of events 117 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	10.7% 50/466 • Number of events 65 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	10.8% 51/474 • Number of events 69 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Infections and infestations Upper respiratory tract infection	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	3.2% 13/410 • Number of events 14 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	4.1% 17/411 • Number of events 18 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	13.3% 62/466 • Number of events 80 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	15.4% 73/474 • Number of events 82 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.24% 1/410 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	1.7% 7/411 • Number of events 7 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	4.1% 19/466 • Number of events 20 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	5.5% 26/474 • Number of events 28 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Gastrointestinal disorders Dysphagia	5.0% 3/60 • Number of events 3 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	1.7% 1/60 • Number of events 1 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/410 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/411 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/466 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.	0.00% 0/474 • Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER