Trial Outcomes & Findings for A Study of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs48/45 in Matrix-M Adjuvant in the UK (NCT NCT05400746)

Last Updated: 2025-03-28

Results Overview

Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

17 participants

Primary outcome timeframe

7 days following each vaccination

Results posted on

2025-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 - Low Dose 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Overall Study STARTED	8	8	1
Overall Study COMPLETED	8	4	0
Overall Study NOT COMPLETED	0	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 - Low Dose 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Overall Study Trial terminated early due to IMP availability	0	4	1

Baseline Characteristics

A Study of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs48/45 in Matrix-M Adjuvant in the UK

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - Low Dose n=8 Participants 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose n=8 Participants 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose n=1 Participants 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Total n=17 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	8 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	17 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
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Other Asian background	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White - British	4 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized White - Other	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian or Asian British - Bangladeshi	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants	8 participants n=7 Participants	1 participants n=5 Participants	17 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 days following each vaccination

Outcome measures

Outcome measures
Measure	Group 1 - Low Dose n=8 Participants 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose n=8 Participants 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose n=1 Participants 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Pain (Mild)	7 Number of participants reporting events	6 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Pain (Moderate)	2 Number of participants reporting events	3 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Pain (Severe)	0 Number of participants reporting events	0 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Warmth (Mild)	4 Number of participants reporting events	6 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Warmth (Moderate)	1 Number of participants reporting events	0 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Warmth (Severe)	0 Number of participants reporting events	0 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Itch (Mild)	2 Number of participants reporting events	0 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Itch (Moderate)	1 Number of participants reporting events	0 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Itch (Severe)	0 Number of participants reporting events	0 Number of participants reporting events	0 Number of participants reporting events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Solicited Local Reactogenicity Signs and Symptoms for 7 Days Following Each Vaccination Redness	7 Number of participants reporting events	5 Number of participants reporting events	1 Number of participants reporting events

PRIMARY outcome

Timeframe: 7 days following each vaccination

Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results.

Outcome measures

PRIMARY outcome

Timeframe: 28 days following the vaccination

Population: A full list of unsolicited adverse events and the number of participants affected by each event is available in the 'Adverse events' section.

Number of unsolicited adverse events (AEs) for 28 days following the vaccination using e-diaries, clinical review, clinical examination (including observations) and laboratory results

Outcome measures

Outcome measures
Measure	Group 1 - Low Dose n=8 Participants 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose n=8 Participants 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose n=1 Participants 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination Unsolicited adverse events - definitely related to the IMP	0 Number of events	0 Number of events	1 Number of events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination Unsolicited adverse events - probably related to the IMP	7 Number of events	3 Number of events	0 Number of events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination Unsolicited adverse events - possibly related to the IMP	13 Number of events	5 Number of events	0 Number of events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination Unsolicited adverse events - unlikely related to the IMP	26 Number of events	9 Number of events	0 Number of events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers by Assessing the Occurrence of Unsolicited Adverse Events (AEs) for 28 Days Following the Vaccination Unsolicited adverse events - no relationship to the IMP	8 Number of events	6 Number of events	0 Number of events

PRIMARY outcome

Timeframe: 28 days following vaccination

Occurrence of change from baseline laboratory tests

Outcome measures

Outcome measures
Measure	Group 1 - Low Dose n=8 Participants 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose n=8 Participants 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose n=1 Participants 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results Mild abnormalities	5 Number of participants with events	4 Number of participants with events	0 Number of participants with events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results Moderate abnormalities	0 Number of participants with events	1 Number of participants with events	0 Number of participants with events
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers. Assessed Through the Number of Participants With Abnormal Laboratory Test Results Severe abnormalities	0 Number of participants with events	0 Number of participants with events	0 Number of participants with events

PRIMARY outcome

Timeframe: Whole duration of the study (8 months following initial trial vaccination)

Occurrence of serious adverse events will be presented according to local grading scales

Outcome measures

Outcome measures
Measure	Group 1 - Low Dose n=8 Participants 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose n=8 Participants 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose n=1 Participants 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers Assessed Through the Number of Participants With Serious Adverse Events	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Whole duration of the study (8 months following initial trial vaccination)

Occurrence of AEs of special interest will be presented according to local grading scales and will be described in detail

Outcome measures

Outcome measures
Measure	Group 1 - Low Dose n=8 Participants 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose n=8 Participants 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose n=1 Participants 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Safety and Tolerability of the Pfs48/45 With Matrix-M Vaccine at Various Doses in Healthy Adult Volunteers.	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 1, 29, 57, 140 and 240

Other events: 7 other events

Deaths: 0 deaths

Group 3 - Fractional Dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Angela M Minassian

University of Oxford

Phone: 01865611424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Group 1 - Low Dose n=8 participants at risk 8-10 volunteers receiving three doses of 10 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 2 - Standard Dose n=8 participants at risk 8-10 volunteers receiving three doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses	Group 3 - Fractional Dose n=1 participants at risk 8-10 volunteers receiving two doses of 50 µg Pfs48/45 in 50 µg Matrix-M on days 0 and 28, followed by one dose of 10 µg Pfs48/45 in 50 µg Matrix-M on day 56 via intramuscular injection (IM) in the deltoid region of the arm Pfs48/45 in Matrix-M: Three doses of Pfs48/45 in Matrix-M at different doses
Gastrointestinal disorders Nausea / Stomach issues	25.0% 2/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	25.0% 2/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Musculoskeletal and connective tissue disorders Back and shoulder ache	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Skin and subcutaneous tissue disorders Bruising to vaccination site	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	100.0% 1/1 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Skin and subcutaneous tissue disorders Burn	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Chest Pain	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Respiratory, thoracic and mediastinal disorders Cough	37.5% 3/8 • Number of events 3 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Infections and infestations covid-19	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Dizzy spells	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Infections and infestations Eye infection	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Fatigue	25.0% 2/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Headache	87.5% 7/8 • Number of events 7 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Heavy feeling to arm of vaccination	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Skin and subcutaneous tissue disorders Impetigo	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Infections and infestations Infected Wisdom Tooth	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Musculoskeletal and connective tissue disorders Injury to Coccyx	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Insect bites	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Skin and subcutaneous tissue disorders Itching to vaccination site (pruritus)	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Sore throat	37.5% 3/8 • Number of events 4 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Jaw Ache	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Skin and subcutaneous tissue disorders Large Blister	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Reproductive system and breast disorders Epididymitis	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Reproductive system and breast disorders Dysmenorrhea/longer menstrual bleeding	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	25.0% 2/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Nervous system disorders Migraine	25.0% 2/8 • Number of events 9 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	50.0% 4/8 • Number of events 5 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Night Sweats	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Nose Bleed	12.5% 1/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Pain at injection site	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Pangs in hands	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Restlessness/insomnia	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Musculoskeletal and connective tissue disorders Right upper limb	25.0% 2/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Respiratory, thoracic and mediastinal disorders Shortness of breath	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Sinus Pain	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Sneezing	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Throat ulcers	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Tingling in left wrist	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
General disorders Twisted ankle	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/8 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Skin and subcutaneous tissue disorders Pain at injection site - moderate	25.0% 2/8 • Number of events 2 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	37.5% 3/8 • Number of events 5 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.
Skin and subcutaneous tissue disorders Pain at injection site - mild	87.5% 7/8 • Number of events 26 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	75.0% 6/8 • Number of events 25 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.	0.00% 0/1 • Adverse events were collected from enrolment till the end of study visit for each volunteer (the duration of each volunteer's involvement in the study lasted up to 11.5 months). Systematic events collected via a participant-completed diary. Non-systematic events collected through a combination of the participant-completed diary and discussions at visits.