Trial Outcomes & Findings for Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU (NCT NCT02998996)

NCT ID: NCT02998996

Last Updated: 2019-02-21

Results Overview

Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 162 participants
• Primary outcome timeframe: Pre-dose, and 15 and 120 min after study drug administration (Visit 2).
• Results posted on: 2019-02-21

Participant Flow

Participant milestones

Measure	Immunose™ FLU 1%, 15 µg haemagglutinin(HA)/strain and 1% Endocine™ 15 µg HA/strain and 1% Endocine™: intranasal administration	Immunose™ FLU 2%, 15 µg HA/strain and 2% Endocine™ 15 µg HA/strain and 2% Endocine™: intranasal administration	Influenza Antigen, 15 µg HA/strain 15 µg HA/strain: intranasal administration	Saline (NaCl), Placebo Placebo, Saline: intranasal administration	i.m. Comparator, 15 µg HA/strain intramuscular comparator: intramuscular administration	i.n. Comparator intranasal comparator: intranasal administration
Overall Study STARTED	36	35	36	18	18	19
Overall Study COMPLETED	36	34	35	18	17	19
Overall Study NOT COMPLETED	0	1	1	0	1	0

Reasons for withdrawal

Measure	Immunose™ FLU 1%, 15 µg haemagglutinin(HA)/strain and 1% Endocine™ 15 µg HA/strain and 1% Endocine™: intranasal administration	Immunose™ FLU 2%, 15 µg HA/strain and 2% Endocine™ 15 µg HA/strain and 2% Endocine™: intranasal administration	Influenza Antigen, 15 µg HA/strain 15 µg HA/strain: intranasal administration	Saline (NaCl), Placebo Placebo, Saline: intranasal administration	i.m. Comparator, 15 µg HA/strain intramuscular comparator: intramuscular administration	i.n. Comparator intranasal comparator: intranasal administration
Overall Study Lost to Follow-up	0	0	1	0	0	0
Overall Study Pregnancy	0	1	0	0	0	0
Overall Study Family reasons	0	0	0	0	1	0

Baseline Characteristics

Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU

Baseline characteristics by cohort

Measure	Immunose™ FLU 1%, n=36 Participants 15 µg haemagglutinin(HA)/strain and 1% Endocine™ 15 µg HA/strain and 1% Endocine™: intranasal administration	Immunose™ FLU 2%, n=35 Participants 15 µg HA/strain and 2% Endocine™ 15 µg HA/strain and 2% Endocine™: intranasal administration	Influenza Antigen, n=36 Participants 15 µg HA/strain 15 µg HA/strain: intranasal administration	Saline (NaCl), n=18 Participants Placebo Placebo, Saline: intranasal administration	i.m. Comparator, n=18 Participants 15 µg HA/strain intramuscular comparator: intramuscular administration	i.n. Comparator n=19 Participants intranasal comparator: intranasal administration	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	35 Participants n=7 Participants	36 Participants n=5 Participants	18 Participants n=4 Participants	18 Participants n=21 Participants	19 Participants n=10 Participants	162 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	26.36 years STANDARD_DEVIATION 5.69 • n=5 Participants	26.34 years STANDARD_DEVIATION 5.46 • n=7 Participants	25.11 years STANDARD_DEVIATION 4.8 • n=5 Participants	27.72 years STANDARD_DEVIATION 5.6 • n=4 Participants	27.22 years STANDARD_DEVIATION 4.75 • n=21 Participants	24.68 years STANDARD_DEVIATION 4.32 • n=10 Participants	26.13 years STANDARD_DEVIATION 5.20 • n=115 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	15 Participants n=4 Participants	9 Participants n=21 Participants	8 Participants n=10 Participants	91 Participants n=115 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants	11 Participants n=10 Participants	71 Participants n=115 Participants
Race/Ethnicity, Customized Ethnicity · African descent	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race/Ethnicity, Customized Ethnicity · Asian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	35 Participants n=5 Participants	32 Participants n=7 Participants	34 Participants n=5 Participants	17 Participants n=4 Participants	17 Participants n=21 Participants	19 Participants n=10 Participants	154 Participants n=115 Participants
Race/Ethnicity, Customized Ethnicity · Mixed/multi-racial	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Region of Enrollment Sweden	36 participants n=5 Participants	35 participants n=7 Participants	36 participants n=5 Participants	18 participants n=4 Participants	18 participants n=21 Participants	19 participants n=10 Participants	162 participants n=115 Participants

PRIMARY outcome

Timeframe: Pre-dose, and 15 and 120 min after study drug administration (Visit 2).

Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.

Outcome measures

Measure	Immunose™ FLU 1%, n=36 Participants 15 µg haemagglutinin(HA)/strain and 1% Endocine™ 15 µg HA/strain and 1% Endocine™: intranasal administration	Immunose™ FLU 2%, n=35 Participants 15 µg HA/strain and 2% Endocine™ 15 µg HA/strain and 2% Endocine™: intranasal administration	Influenza Antigen, n=36 Participants 15 µg HA/strain 15 µg HA/strain: intranasal administration	Saline (NaCl), n=18 Participants Placebo Placebo, Saline: intranasal administration	i.m. Comparator, n=18 Participants 15 µg HA/strain intramuscular comparator: intramuscular administration	i.n. Comparator n=19 Participants intranasal comparator: intranasal administration
Local Tolerability - First Dose Pre-dose	5 Participants	4 Participants	9 Participants	0 Participants	0 Participants	4 Participants
Local Tolerability - First Dose 15 min post-dose	11 Participants	10 Participants	7 Participants	0 Participants	9 Participants	3 Participants
Local Tolerability - First Dose 120 min post-dose	9 Participants	5 Participants	7 Participants	0 Participants	6 Participants	1 Participants

PRIMARY outcome

Timeframe: Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).

Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.

Outcome measures

Measure	Immunose™ FLU 1%, n=36 Participants 15 µg haemagglutinin(HA)/strain and 1% Endocine™ 15 µg HA/strain and 1% Endocine™: intranasal administration	Immunose™ FLU 2%, n=35 Participants 15 µg HA/strain and 2% Endocine™ 15 µg HA/strain and 2% Endocine™: intranasal administration	Influenza Antigen, n=36 Participants 15 µg HA/strain 15 µg HA/strain: intranasal administration	Saline (NaCl), n=18 Participants Placebo Placebo, Saline: intranasal administration	i.m. Comparator, 15 µg HA/strain intramuscular comparator: intramuscular administration	i.n. Comparator intranasal comparator: intranasal administration
Local Tolerability - Second Dose (Group 1-4 Only) Pre-dose	8 Participants	8 Participants	7 Participants	2 Participants	—	—
Local Tolerability - Second Dose (Group 1-4 Only) 15 min post-dose	16 Participants	12 Participants	10 Participants	2 Participants	—	—
Local Tolerability - Second Dose (Group 1-4 Only) 120 min post-dose	10 Participants	8 Participants	5 Participants	1 Participants	—	—

Adverse Events

Immunose™ FLU 1%,

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Immunose™ FLU 2%,

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Influenza Antigen,

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Saline (NaCl),

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

i.m. Comparator,

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

i.n. Comparator

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Immunose™ FLU 1%, n=36 participants at risk 15 µg haemagglutinin(HA)/strain and 1% Endocine™ 15 µg HA/strain and 1% Endocine™: intranasal administration	Immunose™ FLU 2%, n=35 participants at risk 15 µg HA/strain and 2% Endocine™ 15 µg HA/strain and 2% Endocine™: intranasal administration	Influenza Antigen, n=36 participants at risk 15 µg HA/strain 15 µg HA/strain: intranasal administration	Saline (NaCl), n=18 participants at risk Placebo Placebo, Saline: intranasal administration	i.m. Comparator, n=18 participants at risk 15 µg HA/strain intramuscular comparator: intramuscular administration	i.n. Comparator n=19 participants at risk intranasal comparator: intranasal administration
Infections and infestations Eryipelas	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Infections and infestations Gastroenteritis bacterial	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.

Other adverse events

Measure	Immunose™ FLU 1%, n=36 participants at risk 15 µg haemagglutinin(HA)/strain and 1% Endocine™ 15 µg HA/strain and 1% Endocine™: intranasal administration	Immunose™ FLU 2%, n=35 participants at risk 15 µg HA/strain and 2% Endocine™ 15 µg HA/strain and 2% Endocine™: intranasal administration	Influenza Antigen, n=36 participants at risk 15 µg HA/strain 15 µg HA/strain: intranasal administration	Saline (NaCl), n=18 participants at risk Placebo Placebo, Saline: intranasal administration	i.m. Comparator, n=18 participants at risk 15 µg HA/strain intramuscular comparator: intramuscular administration	i.n. Comparator n=19 participants at risk intranasal comparator: intranasal administration
Respiratory, thoracic and mediastinal disorders Cough	22.2% 8/36 • Number of events 9 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	17.1% 6/35 • Number of events 7 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	22.2% 8/36 • Number of events 9 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.7% 2/35 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 3/36 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Nasal congestion	41.7% 15/36 • Number of events 25 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	57.1% 20/35 • Number of events 31 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	36.1% 13/36 • Number of events 19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	36.8% 7/19 • Number of events 9 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Nasal muscosal disorder	27.8% 10/36 • Number of events 11 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	20.0% 7/35 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	13.9% 5/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Nasal pruritus	19.4% 7/36 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	14.3% 5/35 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	22.2% 8/36 • Number of events 14 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	41.7% 15/36 • Number of events 28 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	37.1% 13/35 • Number of events 23 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	27.8% 10/36 • Number of events 16 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	27.8% 5/18 • Number of events 7 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 3/18 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	11.1% 4/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.7% 2/35 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Rhinalgia	19.4% 7/36 • Number of events 11 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	28.6% 10/35 • Number of events 12 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 6/36 • Number of events 9 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	41.7% 15/36 • Number of events 20 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	34.3% 12/35 • Number of events 20 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	19.4% 7/36 • Number of events 9 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 3/18 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 3/18 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	21.1% 4/19 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Sinus pain	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Sneezing	25.0% 9/36 • Number of events 10 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	22.9% 8/35 • Number of events 15 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	33.3% 12/36 • Number of events 17 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	21.1% 4/19 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Respiratory, thoracic and mediastinal disorders Throat irritation	61.1% 22/36 • Number of events 38 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	60.0% 21/35 • Number of events 38 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	8.3% 3/36 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Nervous system disorders Dizziness	8.3% 3/36 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Nervous system disorders Headache	27.8% 10/36 • Number of events 18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	28.6% 10/35 • Number of events 17 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	38.9% 14/36 • Number of events 17 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 3/18 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	27.8% 5/18 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	31.6% 6/19 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Application site erythema	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Application site swelling	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Chills	16.7% 6/36 • Number of events 7 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	17.1% 6/35 • Number of events 6 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	8.3% 3/36 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Fatigue	36.1% 13/36 • Number of events 22 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	37.1% 13/35 • Number of events 22 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	38.9% 14/36 • Number of events 22 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	27.8% 5/18 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	44.4% 8/18 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	21.1% 4/19 • Number of events 6 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Injection site erythema	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	22.2% 4/18 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Injection site hypoaesthesia	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Injection site pain	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	38.9% 7/18 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Injection site paraesthesia	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Injection site pruritus	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Injection site reaction	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Injection site swelling	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 3/18 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Malaise	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Pain	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Pyrexia	25.0% 9/36 • Number of events 11 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.7% 2/35 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 4/36 • Number of events 6 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
General disorders Swelling	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Ear and labyrinth disorders Ear pain	5.6% 2/36 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Gastrointestinal disorders Abdominal pain	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Gastrointestinal disorders Nausea	16.7% 6/36 • Number of events 9 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.7% 2/35 • Number of events 6 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 4/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 3/18 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Gastrointestinal disorders Oral discomfort	11.1% 4/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.9% 1/35 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Gastrointestinal disorders Oral pruritus	11.1% 4/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.7% 2/35 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Gastrointestinal disorders Toothache	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Psychiatric disorders Depression	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Skin and subcutaneous tissue disorders Erythema	2.8% 1/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.7% 2/35 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Skin and subcutaneous tissue disorders Hyperhidrosis	11.1% 4/36 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.4% 4/35 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	13.9% 5/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Skin and subcutaneous tissue disorders Pruritus	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	8.6% 3/35 • Number of events 3 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	2.8% 1/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Musculoskeletal and connective tissue disorders Arthralgia	13.9% 5/36 • Number of events 8 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 3/18 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Musculoskeletal and connective tissue disorders Back pain	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 4/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.7% 2/35 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	16.7% 6/36 • Number of events 7 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	22.2% 4/18 • Number of events 4 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/36 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.3% 1/19 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Infections and infestations Nasopharyngitis	13.9% 5/36 • Number of events 5 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	17.1% 6/35 • Number of events 6 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 1/18 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.
Infections and infestations Gastroenteritis	2.8% 1/36 • Number of events 1 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/35 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	5.6% 2/36 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/18 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	11.1% 2/18 • Number of events 2 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.	0.00% 0/19 • From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.

Additional Information

Anna-Karin Maltais

Eurocine Vaccines AB

Phone: +46 76 233 81 62

Email: annakarin.maltais@eurocine-vaccines.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place