Trial Outcomes & Findings for Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine (NCT NCT05270265)
NCT ID: NCT05270265
Last Updated: 2026-01-15
Results Overview
Number of serious adverse events reported per group throughout the study period.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Whole duration of the study period (8 months following enrolment)
Results posted on
2026-01-15
Participant Flow
Participant milestones
| Measure |
Group 1 (Low Dose)
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (Low Dose)
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine
Baseline characteristics by cohort
| Measure |
Group 1 (Low Dose)
n=8 Participants
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
n=9 Participants
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
n=8 Participants
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
29.5 years
n=14 Participants
|
32 years
n=10 Participants
|
27 years
n=24 Participants
|
29 years
n=78 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=14 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=24 Participants
|
13 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=24 Participants
|
12 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
White British
|
4 Participants
n=14 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=24 Participants
|
13 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
White Irish
|
0 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
White Other
|
2 Participants
n=14 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black or Black British - African
|
0 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Other Asian Background
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Other - Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: 7 days following each vaccinationPopulation: Percentages are the proportion of participants in each group that reported each symptom after at least one vaccination. Group 1: All participants received three vaccinations Group 2: 9 participants received vaccinations 1 and 2, 7 participants received vaccination 3 Group 3: 8 participants received vaccinations 1 and 2, 6 participants received vaccination 3
Number of participants in each group who reported solicited local reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited local reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Outcome measures
| Measure |
Group 1 (Low Dose)
n=8 Participants
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
n=9 Participants
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
n=8 Participants
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Warmth: Mild
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Warmth: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Warmth: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Redness: Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Redness: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Redness: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Itch: Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Itch: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Itch: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Pain: Mild
|
8 Participants
|
7 Participants
|
5 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Pain: Moderate
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Pain: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days following each vaccinationPopulation: Percentages are the proportion of participants in each group that reported each symptom after at least one vaccination. Group 1: All participants received three vaccinations Group 2: 9 participants received vaccinations 1 and 2, 7 participants received vaccination 3 Group 3: 8 participants received vaccinations 1 and 2, 6 participants received vaccination 3
Number of participants in each group who reported solicited systemic reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited systemic reactogenicity signs and symptoms are collected through participant-reported e-diaries.
Outcome measures
| Measure |
Group 1 (Low Dose)
n=8 Participants
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
n=9 Participants
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
n=8 Participants
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Arthralgia: Mild
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Feverishness: Mild
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Feverishness: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Arthralgia: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Feverishness: Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Arthralgia: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Fatigue: Mild
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Nausea: Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Nausea: Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Nausea: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Fatigue: Moderate
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Fatigue: Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Myalgia: Mild
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Headache: Mild
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Myalgia: Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Myalgia: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Headache: Moderate
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Headache: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Malaise: Mild
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Malaise: Moderate
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Malaise: Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Fever: Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Fever: Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Fever: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days following each vaccinationUnsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries.
Outcome measures
| Measure |
Group 1 (Low Dose)
n=8 Participants
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
n=9 Participants
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
n=8 Participants
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Total unsolicited adverse events (UAEs)
|
56 Number of events
|
54 Number of events
|
53 Number of events
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
UAEs - no relationship to investigational vaccine
|
26 Number of events
|
20 Number of events
|
14 Number of events
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
UAEs - unlikely related to investigational vaccine
|
22 Number of events
|
21 Number of events
|
31 Number of events
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
UAEs - possibly related to investigational vaccine
|
5 Number of events
|
12 Number of events
|
6 Number of events
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
UAEs - probably related to investigational vaccine
|
3 Number of events
|
1 Number of events
|
2 Number of events
|
|
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
UAEs - definitely related to investigational vaccine
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
PRIMARY outcome
Timeframe: 28 days following vaccinationOccurrence of change from baseline laboratory test results
Outcome measures
| Measure |
Group 1 (Low Dose)
n=8 Participants
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
n=9 Participants
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
n=8 Participants
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Grade 3 laboratory abnormalities
|
0 Number of abnormal laboratory results
|
2 Number of abnormal laboratory results
|
1 Number of abnormal laboratory results
|
|
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Grade 1 laboratory abnormalities
|
47 Number of abnormal laboratory results
|
25 Number of abnormal laboratory results
|
21 Number of abnormal laboratory results
|
|
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Grade 2 laboratory abnormalities
|
3 Number of abnormal laboratory results
|
5 Number of abnormal laboratory results
|
4 Number of abnormal laboratory results
|
PRIMARY outcome
Timeframe: Whole duration of the study period (8 months following enrolment)Number of serious adverse events reported per group throughout the study period.
Outcome measures
| Measure |
Group 1 (Low Dose)
n=8 Participants
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2 (Standard Dose)
n=9 Participants
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3 (Fractional Dose)
n=8 Participants
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
|
0 Number of serious adverse events
|
0 Number of serious adverse events
|
0 Number of serious adverse events
|
SECONDARY outcome
Timeframe: Days 1, 29, 57, 140 and 240.Antibody responses to the Pvs25 protein will be assessed through total IgG isotypes and avidity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1, 29, 57, 140 and 240.T cell responses to Pvs25 will be assessed by ex vivo enzyme-linked immunospot assays (ELISpot) and flow cytometry assays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1, 29, 57, 140 and 240.Transmission-reducing activity will be assessed through direct membrane feeding assays (DMFA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1, 29, 57, 140 and 240.Transmission-blocking activity will be assessed through direct membrane feeding assays (DMFA).
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Low Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: Mid Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3: Fractional Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Low Dose
n=8 participants at risk
8 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 2: Mid Dose
n=9 participants at risk
9 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm
|
Group 3: Fractional Dose
n=8 participants at risk
8 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Blocked nose
|
12.5%
1/8 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
50.0%
4/8 • Number of events 5 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Infections and infestations
COVID-19
|
37.5%
3/8 • Number of events 3 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Reproductive system and breast disorders
Menstrual cramps/pain
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Injury, poisoning and procedural complications
Dog bite
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Fatigue
|
37.5%
3/8 • Number of events 3 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
44.4%
4/9 • Number of events 4 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Immune system disorders
Feverishness
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
22.2%
2/9 • Number of events 3 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Flu-like illness
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Reproductive system and breast disorders
Gonorrhoea
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 14 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
55.6%
5/9 • Number of events 8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
50.0%
4/8 • Number of events 9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Cardiac disorders
Heartburn
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Heatstroke
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Hypokalaemia
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Injury, poisoning and procedural complications
Insect bite
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Blood and lymphatic system disorders
Iron-deficiency anemia
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Cardiac disorders
Irregular heartbeat
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Skin and subcutaneous tissue disorders
Itch
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Reproductive system and breast disorders
IUD complications
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Joint ache
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Psychiatric disorders
Low mood
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Malaise
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
37.5%
3/8 • Number of events 4 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Migraine
|
12.5%
1/8 • Number of events 8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Skin and subcutaneous tissue disorders
Mild eczema
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Muscle ache
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Nasal congestion
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Neck and shoulder ache
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Neck pain
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
25.0%
2/8 • Number of events 3 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Nervous system disorders
Photophobia
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Pulled hamstring
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Immune system disorders
Rhinorrhoea
|
50.0%
4/8 • Number of events 4 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
37.5%
3/8 • Number of events 3 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Rhinosinusitis
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Immune system disorders
Seasonal allergies
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Immune system disorders
Sinus pain
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Sneezing
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Sore neck
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
2/8 • Number of events 6 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
55.6%
5/9 • Number of events 10 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
62.5%
5/8 • Number of events 7 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Gastrointestinal disorders
Stomach ache/cramps
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Infections and infestations
Thrush
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Immune system disorders
Tonsillar disorder
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Toothache
|
25.0%
2/8 • Number of events 2 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
General disorders
Vitamin D deficiency
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
11.1%
1/9 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Whiplash
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
|
Ear and labyrinth disorders
Whooshing sound in one ear
|
0.00%
0/8 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
0.00%
0/9 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
12.5%
1/8 • Number of events 1 • Solicited adverse event data was collected for 7 days post-vaccination. Unsolicited adverse event data was collected for 28 days post-vaccination.
Solicited adverse events, along with severity and the number of participants affected per study group by each event, have been reported as part of the primary outcome measures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place