Trial Outcomes & Findings for Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine (NCT NCT05005247)

NCT ID: NCT05005247

Last Updated: 2024-10-10

Results Overview

Number of participants with treatment emergent adverse events

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

27 participants

Primary outcome timeframe

12 weeks (Day 85)

Results posted on

2024-10-10

Participant Flow

Participants were recruited based on their participation on the previous MVX0002 study. The first participant was enrolled on August 17, 2021 and the last one was enrolled on August 8, 2022.

27 patients were enrolled and received the study vaccine. 1 participant was withdrawn and not replaced (the participant requested withdrawal from the study).

Participant milestones

Participant milestones
Measure	MVX0002 25 μg GBS-NN/NN2 Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
Overall Study STARTED	10	7	10
Overall Study COMPLETED	10	6	10
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MVX0002 25 μg GBS-NN/NN2 Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 weeks (Day 85)

Number of participants with treatment emergent adverse events

Outcome measures

Outcome measures
Measure	MVX0002 25 μg GBS-NN/NN2 n=10 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 n=7 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve n=10 Participants Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
Treatment Emergent Adverse Events Number of participants reporting at least one TEAE	10 Participants	7 Participants	10 Participants
Treatment Emergent Adverse Events Number of participants with Mild TEAE	4 Participants	2 Participants	4 Participants
Treatment Emergent Adverse Events Number of participants with Moderate TEAE	6 Participants	5 Participants	6 Participants
Treatment Emergent Adverse Events Number of participants with Severe TEAE	0 Participants	0 Participants	0 Participants
Treatment Emergent Adverse Events Number of participants with TEAE by relationship to Study Drug: Reasonable Possibility	10 Participants	4 Participants	8 Participants
Treatment Emergent Adverse Events Number of participants with TEAE by relationship to Study Drug: No Reasonable Possibility	0 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months (Day 183)

Number of participants with treatment emergent adverse events

Outcome measures

Outcome measures
Measure	MVX0002 25 μg GBS-NN/NN2 n=10 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 n=7 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve n=10 Participants Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
Treatment Emergent Adverse Events	5 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 85

Population: Immunogenicity Set

Absolute values of antibody concentration specific for GBS-NN and GBS-NN2

Outcome measures

Outcome measures
Measure	MVX0002 25 μg GBS-NN/NN2 n=10 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 n=6 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve n=10 Participants Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) Anti-GBSNN antibodies : Day 1 (Absolute value)	3.4314 μg/mL Interval 1.1644 to 10.1115	6.5606 μg/mL Interval 4.7386 to 9.0827	0.0838 μg/mL Interval 0.0363 to 0.1932
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) Anti-GBSNN antibodies : Day 85 (Absolute value)	45.4768 μg/mL Interval 27.5667 to 75.023	83.3289 μg/mL Interval 40.7246 to 170.5038	1.6497 μg/mL Interval 0.8161 to 3.3347
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) Anti-GBSNN2 antibodies : Day 1 (Absolute value)	7.0260 μg/mL Interval 1.9392 to 25.4559	6.7734 μg/mL Interval 1.4783 to 31.0356	0.2275 μg/mL Interval 0.1365 to 0.3793
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Absolute Values) Anti-GBSNN2 antibodies : Day 85 (Absolute value)	61.4636 μg/mL Interval 39.0362 to 96.7762	109.9307 μg/mL Interval 67.0156 to 180.3275	4.7237 μg/mL Interval 2.8023 to 7.9625

SECONDARY outcome

Timeframe: From Day 1 to Day 85

Population: Immunogenicity Set

Geometric mean fold increase in antibody concentration specific for GBS-NN and GBS-NN2

Outcome measures

Outcome measures
Measure	MVX0002 25 μg GBS-NN/NN2 n=10 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 n=6 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve n=10 Participants Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) Anti-GBSNN antibodies (fold increase)	13.25 ratio Interval 4.78 to 36.77	12.70 ratio Interval 6.32 to 25.52	19.70 ratio Interval 12.11 to 32.03
Antibody Concentration Specific for GBS-NN and GBS-NN2 (Fold Increase) Anti-GBSNN2 antibodies (fold increase)	8.75 ratio Interval 2.13 to 36.0	16.23 ratio Interval 4.49 to 58.61	20.76 ratio Interval 11.04 to 39.04

SECONDARY outcome

Timeframe: MVX002 day 85, MVX003 day 1 and MVX003 day 85

Population: Only participants who received placebo during the MVX0002 study were analyzed for this outcome measure in the "MVX0002 Placebo/Vaccine Naïve" arm. Vaccine naïve participants were excluded.

Geometric least square mean of antibody concentrations specific for GBS-NN and GBS-NN2 at day 85 of MVX002 study and day 1 and 85 of MVX003 study.

Outcome measures

Outcome measures
Measure	MVX0002 25 μg GBS-NN/NN2 n=10 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 n=6 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve n=5 Participants Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
Antibody Concentration Specific for GBS-NN and GBS-NN2 Anti-GBSNN Antibody - MVX003 Day 85	45.5 μg/mL Interval 22.1 to 93.6	83.3 μg/mL Interval 47.3 to 147.0	1.59 μg/mL Interval 0.396 to 6.4
Antibody Concentration Specific for GBS-NN and GBS-NN2 Anti-GBSNN Antibody - MVX002 Day 85	11.8 μg/mL Interval 4.37 to 31.7	22.6 μg/mL Interval 16.1 to 31.9	0.0247 μg/mL Interval 0.00426 to 0.144
Antibody Concentration Specific for GBS-NN and GBS-NN2 Anti-GBSNN Antibody - MVX003 Day 1	3.43 μg/mL Interval 1.28 to 9.23	6.56 μg/mL Interval 4.66 to 9.24	0.0669 μg/mL Interval 0.0115 to 0.389
Antibody Concentration Specific for GBS-NN and GBS-NN2 Anti-GBSNN2 Antibody - MVX002 Day 85	29.1 μg/mL Interval 9.56 to 88.4	31.0 μg/mL Interval 8.57 to 112.0	0.117 μg/mL Interval 0.0411 to 0.33
Antibody Concentration Specific for GBS-NN and GBS-NN2 Anti-GBSNN2 Antibody - MVX003 Day 1	7.03 μg/mL Interval 2.31 to 21.4	6.77 μg/mL Interval 1.87 to 24.5	0.206 μg/mL Interval 0.0726 to 0.584
Antibody Concentration Specific for GBS-NN and GBS-NN2 Anti-GBSNN2 Antibody - MVX003 Day 85	61.5 μg/mL Interval 30.1 to 126.0	110 μg/mL Interval 50.1 to 241.0	4.42 μg/mL Interval 1.52 to 12.8

Adverse Events

MVX0002 25 μg GBS-NN/NN2

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

MVX0002 50 μg GBS-NN/NN2

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

MVX0002 Placebo/Vaccine Naïve

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

CMO

MinervaX

Phone: 004553883002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MVX0002 25 μg GBS-NN/NN2 n=10 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 n=7 Participants Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve n=10 Participants Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.	Total n=27 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
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 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
Age, Continuous	31.4 years STANDARD_DEVIATION 5.60 • n=5 Participants	34.6 years STANDARD_DEVIATION 5.83 • n=7 Participants	29.2 years STANDARD_DEVIATION 7.51 • n=5 Participants	31.4 years STANDARD_DEVIATION 6.54 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United Kingdom	10 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants	27 participants n=4 Participants
Height	1.644 meters STANDARD_DEVIATION 0.0578 • n=5 Participants	1.639 meters STANDARD_DEVIATION 0.0805 • n=7 Participants	1.633 meters STANDARD_DEVIATION 0.0691 • n=5 Participants	1.639 meters STANDARD_DEVIATION 0.0658 • n=4 Participants
Weight	68.98 kg STANDARD_DEVIATION 6.870 • n=5 Participants	68.33 kg STANDARD_DEVIATION 9.408 • n=7 Participants	69.53 kg STANDARD_DEVIATION 9.625 • n=5 Participants	69.01 kg STANDARD_DEVIATION 8.310 • n=4 Participants
BMI	25.559 kg/m² STANDARD_DEVIATION 2.6777 • n=5 Participants	25.396 kg/m² STANDARD_DEVIATION 2.3944 • n=7 Participants	25.999 kg/m² STANDARD_DEVIATION 2.4144 • n=5 Participants	25.680 kg/m² STANDARD_DEVIATION 2.4268 • n=4 Participants

Other adverse events
Measure	MVX0002 25 μg GBS-NN/NN2 n=10 participants at risk Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 25 μg in the previous study MVX0002.	MVX0002 50 μg GBS-NN/NN2 n=7 participants at risk Patients received a booster dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2 following an initial primary vaccination course with the vaccine GBS-NN/NN2 50 μg in the previous study MVX0002.	MVX0002 Placebo/Vaccine Naïve n=10 participants at risk Vaccine naïve participants (either placebo recipients from study MVX0002 or new vaccine naïve participants) received a dose of the group B streptococcus (GBS) vaccine GBS-NN/NN2.
General disorders Injection site reaction	100.0% 10/10 • Number of events 10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	85.7% 6/7 • Number of events 6 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	80.0% 8/10 • Number of events 8 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Nervous system disorders Headache	60.0% 6/10 • Number of events 13 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	42.9% 3/7 • Number of events 5 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	80.0% 8/10 • Number of events 13 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
General disorders Fatigue	50.0% 5/10 • Number of events 5 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	28.6% 2/7 • Number of events 2 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	40.0% 4/10 • Number of events 5 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • Number of events 2 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	28.6% 2/7 • Number of events 2 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	50.0% 5/10 • Number of events 5 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Infections and infestations COVID-19	30.0% 3/10 • Number of events 3 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	30.0% 3/10 • Number of events 3 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
General disorders Influenza like illness	20.0% 2/10 • Number of events 2 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Infections and infestations Upper respiratory tract infection	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	20.0% 2/10 • Number of events 2 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Psychiatric disorders Anxiety	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	20.0% 2/10 • Number of events 2 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Musculoskeletal and connective tissue disorders Back Pain	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
General disorders Chest Pain	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
General disorders Chronic fatigue syndrome	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Injury, poisoning and procedural complications Fall	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Skin and subcutaneous tissue disorders Lichen sclerosus	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Infections and infestations Lower respiratory tract infection	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Gastrointestinal disorders Mouth ulceration	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
General disorders Pain	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 2 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Nervous system disorders Peroneal nerve palsy	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Infections and infestations Pneumonia	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Gastrointestinal disorders Toothache	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Reproductive system and breast disorders Dysmenorrhoea	10.0% 1/10 • Number of events 3 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Infections and infestations Urinary tract infection	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	14.3% 1/7 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Injury, poisoning and procedural complications Wound	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.
Infections and infestations Nasopharyngitis	10.0% 1/10 • Number of events 1 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/7 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.	0.00% 0/10 • From screening to end of safety follow-up. All Adverse Events (AEs) were recorded, whether considered minor or serious, drug-related, or not. From vaccination (Day 1) to Day 7 solicited and unsolicited AEs were recorded. The following AE were solicited : Injection site reactions, fatigue, headache, myalgia and Influenza like illness. From Day 8 to Day 85 only unsolicited AEs were collected. From Day 86 to Day 183 all AEs were recorded in the Patient Diary Card and evaluated at Visit 7.