Trial Outcomes & Findings for A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1 (NCT NCT02572388)

Last Updated: 2019-11-12

Results Overview

Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

Assessment of solicited AEs in the first 7 days post vaccination.

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 50µg of R21 on days 0, 28, and 56. R21	Group 3 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
Overall Study STARTED	11	4	10	6
Overall Study COMPLETED	10	3	8	4
Overall Study NOT COMPLETED	1	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 50µg of R21 on days 0, 28, and 56. R21	Group 3 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
Overall Study Withdrawal by Subject	1	1	2	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=11 Participants 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 n=4 Participants 50µg of R21 on days 0, 28, and 56. R21	Group 3 n=10 Participants 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 n=6 Participants 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=11 Participants	0 Participants n=4 Participants	0 Participants n=10 Participants	0 Participants n=6 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants	4 Participants n=4 Participants	10 Participants n=10 Participants	6 Participants n=6 Participants	31 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants	0 Participants n=4 Participants	0 Participants n=10 Participants	0 Participants n=6 Participants	0 Participants n=31 Participants
Sex: Female, Male Female	7 Participants n=11 Participants	2 Participants n=4 Participants	5 Participants n=10 Participants	2 Participants n=6 Participants	16 Participants n=31 Participants
Sex: Female, Male Male	4 Participants n=11 Participants	2 Participants n=4 Participants	5 Participants n=10 Participants	4 Participants n=6 Participants	15 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	11 participants n=11 Participants	4 participants n=4 Participants	10 participants n=10 Participants	6 participants n=6 Participants	31 participants n=31 Participants

PRIMARY outcome

Timeframe: Assessment of solicited AEs in the first 7 days post vaccination.

Outcome measures

Outcome measures
Measure	Group 1 n=11 Participants 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 n=4 Participants 50µg of R21 on days 0, 28, and 56. R21	Group 3 n=10 Participants 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 n=6 Participants 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
Safety and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.	103 Number of Adverse Events per group	21 Number of Adverse Events per group	94 Number of Adverse Events per group	21 Number of Adverse Events per group

PRIMARY outcome

Timeframe: Unsolicited AEs to be assessed up to 28 days post vaccination.

Occurrence of unsolicited local and systemic adverse events.

Outcome measures

Outcome measures
Measure	Group 1 n=11 Participants 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 n=4 Participants 50µg of R21 on days 0, 28, and 56. R21	Group 3 n=10 Participants 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 n=6 Participants 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.	11 participants	4 participants	10 participants	6 participants

PRIMARY outcome

Timeframe: 6 months

Population: There is no SAEs in groups 2 and 3

Occurrence of serious adverse events collected from enrolment until the end of the follow-up period.

Outcome measures

Outcome measures
Measure	Group 1 n=11 Participants 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 n=4 Participants 50µg of R21 on days 0, 28, and 56. R21	Group 3 n=10 Participants 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 n=6 Participants 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.	1 Number of Serious AEs	0 Number of Serious AEs	0 Number of Serious AEs	1 Number of Serious AEs

PRIMARY outcome

Timeframe: At Day 0 (baseline), day 7 and day 28 post vaccination

Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.

Outcome measures

Outcome measures
Measure	Group 1 n=11 Participants 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 n=4 Participants 50µg of R21 on days 0, 28, and 56. R21	Group 3 n=10 Participants 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 n=6 Participants 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.	11 participants	4 participants	10 participants	6 participants

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group 4

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=11 participants at risk 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 n=4 participants at risk 50µg of R21 on days 0, 28, and 56. R21	Group 3 n=10 participants at risk 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 n=6 participants at risk 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
Reproductive system and breast disorders Bartholin's cyst	9.1% 1/11 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/10 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/11 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/10 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	16.7% 1/6 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.

Other adverse events

Other adverse events
Measure	Group 1 n=11 participants at risk 10µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 2 n=4 participants at risk 50µg of R21 on days 0, 28, and 56. R21	Group 3 n=10 participants at risk 50µg of R21 mixed with 50µg of Matrix-M on days 0, 28, and 56. R21 Matrix-M1	Group 4 n=6 participants at risk 2µg of R21 mixed with 50µg of Matrix-M R21 Matrix-M1
General disorders Pain	72.7% 8/11 • Number of events 8 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	25.0% 1/4 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	60.0% 6/10 • Number of events 6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	33.3% 2/6 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
General disorders Headache	36.4% 4/11 • Number of events 4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	30.0% 3/10 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	16.7% 1/6 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Skin and subcutaneous tissue disorders Redness	54.5% 6/11 • Number of events 6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	25.0% 1/4 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	20.0% 2/10 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	33.3% 2/6 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Skin and subcutaneous tissue disorders Swelling	9.1% 1/11 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/10 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	16.7% 1/6 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Skin and subcutaneous tissue disorders Itch	27.3% 3/11 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/10 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Skin and subcutaneous tissue disorders Warmth	18.2% 2/11 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	30.0% 3/10 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	16.7% 1/6 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Musculoskeletal and connective tissue disorders Arthralgia	45.5% 5/11 • Number of events 5 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	30.0% 3/10 • Number of events 3 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Musculoskeletal and connective tissue disorders Myalgia	18.2% 2/11 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	10.0% 1/10 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
General disorders Feverishness	0.00% 0/11 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	20.0% 2/10 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	16.7% 1/6 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
General disorders Fatigue	36.4% 4/11 • Number of events 4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	50.0% 5/10 • Number of events 5 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
General disorders Nausea	18.2% 2/11 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	10.0% 1/10 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
General disorders Malaise	9.1% 1/11 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	20.0% 2/10 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	16.7% 1/6 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
General disorders Fever	18.2% 2/11 • Number of events 2 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/10 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Blood and lymphatic system disorders Anaemia	0.00% 0/11 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/4 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	10.0% 1/10 • Number of events 1 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.	0.00% 0/6 • Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.

Additional Information

Adrian V Hill, DPhil FRCP

University of Oxford

Phone: +44 1865 617610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place