Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants. (NCT NCT04915768)
NCT ID: NCT04915768
Last Updated: 2026-04-14
Results Overview
The number and percentage of subjects experiencing each type of reactogenicity sign or symptom was tabulated by severity. For a given symptom, reactogenicity per subject was counted once based on the maximum severity across all assessments. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12)
Results posted on
2026-04-14
Participant Flow
Participant milestones
| Measure |
Group 1: Treatment
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
14
|
12
|
|
Overall Study
Safety Population
|
13
|
12
|
14
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Treatment
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Participant is Unwilling or Unable to Comply with Required Study Procedures
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
|
Overall Study
Reactogenicity symptom
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.
Baseline characteristics by cohort
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34 years
n=193 Participants
|
31.5 years
n=193 Participants
|
30.5 years
n=386 Participants
|
33 years
n=112 Participants
|
32 years
n=103 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
|
Age, Customized
21 - 30 years
|
4 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
7 Participants
n=386 Participants
|
4 Participants
n=112 Participants
|
20 Participants
n=103 Participants
|
|
Age, Customized
31 - 40 years
|
7 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
5 Participants
n=112 Participants
|
22 Participants
n=103 Participants
|
|
Age, Customized
41 - 50 years
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
7 Participants
n=103 Participants
|
|
Age, Customized
Above 50
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
7 Participants
n=386 Participants
|
6 Participants
n=112 Participants
|
23 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
7 Participants
n=386 Participants
|
6 Participants
n=112 Participants
|
28 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
8 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=193 Participants
|
11 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
12 Participants
n=112 Participants
|
43 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
11 Participants
n=112 Participants
|
45 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
12 Participants
n=112 Participants
|
51 Participants
n=103 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12)Population: Started (enrolled).
The number and percentage of subjects experiencing each type of reactogenicity sign or symptom was tabulated by severity. For a given symptom, reactogenicity per subject was counted once based on the maximum severity across all assessments. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema/redness · None
|
11 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Mild
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Induration/swelling · None
|
12 Participants
|
9 Participants
|
13 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Induration/swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
10 Participants
|
8 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12)Population: Started (enrolled).
The number and percentage of subjects experiencing each type of reactogenicity sign or symptom was tabulated by severity. For a given symptom, reactogenicity per subject was counted once based on the maximum severity across all assessments. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Mild
|
7 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Moderate
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12)Population: All enrolled participants
The number and percentage of subjects experiencing each type of systemic reactogenicity sign or symptom was tabulated by severity. For a given symptom, reactogenicity per subject was counted once based on the maximum severity across all assessments. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Nausea · None
|
4 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Nausea · Mild
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Nausea · Moderate
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Joint pain · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Chills · None
|
3 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Chills · Mild
|
6 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Chills · Moderate
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Chills · Severe
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Joint pain · None
|
7 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Joint pain · Mild
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Tired/Feeling unwell · None
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Tired/Feeling unwell · Mild
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Tired/Feeling unwell · Moderate
|
4 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Tired/Feeling unwell · Severe
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Tired/Feeling unwell · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Muscle Aches · None
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Muscle Aches · Mild
|
4 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Joint pain · Moderate
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Muscle Aches · Moderate
|
7 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Muscle Aches · Severe
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Muscle Aches · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Headache · None
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Headache · Mild
|
4 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Headache · Moderate
|
6 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Headache · Severe
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
4 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Temperature (C) · None
|
7 Participants
|
7 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Temperature (C) · Mild
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Temperature (C) · Moderate
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Temperature (C) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Temperature (C) · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Joint pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: All unsolicited adverse events were collected for 30 days after any receipt of study vaccination. Some adverse events (noted in description) were collected for 12 months following any receipt of study product (up to 104 weeks)Population: All enrolled participants
The number and percentage of subjects reporting adverse events was tabulated by severity. For a given participant with multiple adverse events reported, maximum severity was taken. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply). All unsolicited adverse events were collected for 30 days after any receipt of study vaccination. Serious adverse events (SAEs), medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation which were collected throughout the study and for twelve months following any receipt of study product
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs) Tabulated by Maximum Severity Grade
Mild
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs) Tabulated by Maximum Severity Grade
Moderate
|
8 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs) Tabulated by Maximum Severity Grade
Severe
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs) Tabulated by Maximum Severity Grade
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Serious adverse events (SAEs) were collected throughout the study and for 12 months following any receipt of study product (up to 104 weeks)Population: All enrolled participants
The number and percentage of subjects reporting servious adverse events (SAEs). Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Medically attended adverse events (MAAEs) were collected throughout the study and for 12 months following any receipt of study product (up to 104 weeks)Population: All enrolled participants
The number and percentage of subjects reporting medically attended adverse events (MAAEs). Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants Reporting One or More Medically Attended Adverse Events (MAAEs)
|
9 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Adverse events of special interest (AESIs)were collected throughout the study and for 12 months following any receipt of study product (up to 104 weeks)Population: All enrolled participants
The number and percentage of subjects reporting adverse events of special interest (AESIs). Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 12 months following any receipt of study product (up to 104 weeksPopulation: All enrolled participants
From the vaccination and adverse event case report forms, counts are tabulated by treatment arm
Outcome measures
| Measure |
Group 1: Treatment
n=13 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 Participants
300 mcg CH505TF, 3 mcg 3M-052-AF
|
Group 3: Treatment
n=14 Participants
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 Participants
300 mcg CH505TF, 5 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Number of Participants With Study Product Discontinuation Associated With an Unsolicited AE or Reactogenicity
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccinationMeasured by flow cytometry analysis
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccinationNeutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. Response to an isolate was considered positive if the neutralization titer was above a pre-specified cutoff. The pre-specified positivity call was an ID50 (or ID80) value ≥ 10,
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccinationNeutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccinationAssessed by binding Ab multiplex assay (BAMA)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccinationAssessed by binding Ab multiplex assay (BAMA)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccination"Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. Criterion to qualify for the global panel: Any samples resulting in \>60 ID50 titer against CH505TF were tested against the global panel of heterologous Env-pseudotyped viruses that exhibited a tier 2 neutralization phenotype. Response to an isolate was considered positive if the neutralization titer was above a pre-specified cutoff. The pre-specified positivity call was an ID50 (or ID80) value ≥ 10,"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccinationNeutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. Criterion to qualify for the global panel: Any samples resulting in \>60 ID50 titer against CH505TF were tested against the global panel of heterologous Env-pseudotyped viruses that exhibited a tier 2 neutralization phenotype.
Outcome measures
Outcome data not reported
Adverse Events
Group 3: Treatment
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group 4: Treatment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 1: Treatment
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 2: Treatment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 3: Treatment
n=14 participants at risk
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 participants at risk
300 mcg CH505TF, 5 mcg 3M-052-AF
|
Group 1: Treatment
n=13 participants at risk
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 participants at risk
300 mcg CH505TF, 3 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
Other adverse events
| Measure |
Group 3: Treatment
n=14 participants at risk
300 mcg CH505TF, 2.2 mcg 3M-052-AF, 556 mcg Alum
|
Group 4: Treatment
n=12 participants at risk
300 mcg CH505TF, 5 mcg 3M-052-AF
|
Group 1: Treatment
n=13 participants at risk
300 mcg CH505TF, 5 mcg 3M-052-AF, 500 mcg Alum
|
Group 2: Treatment
n=12 participants at risk
300 mcg CH505TF, 3 mcg 3M-052-AF
|
|---|---|---|---|---|
|
Eye disorders
Keratitis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Eye disorders
Vitreous floaters
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
16.7%
2/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
50.0%
7/14 • Number of events 7 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
58.3%
7/12 • Number of events 7 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
69.2%
9/13 • Number of events 9 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
41.7%
5/12 • Number of events 5 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Chills (Solicited)
|
64.3%
9/14 • Number of events 9 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
50.0%
6/12 • Number of events 6 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
76.9%
10/13 • Number of events 10 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
75.0%
9/12 • Number of events 9 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Fatigue
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Injection site discolouration
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Injection site erythema (Solicited)
|
14.3%
2/14 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
25.0%
3/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
15.4%
2/13 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
16.7%
2/12 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Injection site nodule
|
7.1%
1/14 • Number of events 5 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
25.0%
3/12 • Number of events 8 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Injection site pain
|
7.1%
1/14 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Injection site pain (Solicited)
|
100.0%
14/14 • Number of events 14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
100.0%
12/12 • Number of events 12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
100.0%
13/13 • Number of events 13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
100.0%
12/12 • Number of events 12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Injection site pruritus
|
7.1%
1/14 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Injection site swelling (Solicited)
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
16.7%
2/12 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
25.0%
3/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
General disorders
Malaise (Solicited)
|
92.9%
13/14 • Number of events 13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
91.7%
11/12 • Number of events 11 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
92.3%
12/13 • Number of events 12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
83.3%
10/12 • Number of events 10 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Anal chlamydia infection
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
15.4%
2/13 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Monkeypox
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Otitis media
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
16.7%
2/12 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Infections and infestations
Viral infection
|
14.3%
2/14 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
15.4%
2/13 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Lip injury
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
16.7%
2/12 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
16.7%
2/12 • Number of events 4 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Investigations
Blood pressure increased
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
15.4%
2/13 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Investigations
Body temperature increased (Solicited)
|
21.4%
3/14 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
25.0%
3/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
46.2%
6/13 • Number of events 6 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
41.7%
5/12 • Number of events 5 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Investigations
White blood cell count decreased
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
16.7%
2/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Solicited)
|
57.1%
8/14 • Number of events 8 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
58.3%
7/12 • Number of events 7 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
46.2%
6/13 • Number of events 6 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
58.3%
7/12 • Number of events 7 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
85.7%
12/14 • Number of events 12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
83.3%
10/12 • Number of events 10 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
92.3%
12/13 • Number of events 12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
83.3%
10/12 • Number of events 10 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Nervous system disorders
Headache (Solicited)
|
71.4%
10/14 • Number of events 10 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
91.7%
11/12 • Number of events 11 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
100.0%
13/13 • Number of events 13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
83.3%
10/12 • Number of events 10 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Nervous system disorders
Migraine
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Psychiatric disorders
Depressed mood
|
7.1%
1/14 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 2 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 6 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
8.3%
1/12 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Vascular disorders
Hot flush
|
7.1%
1/14 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/13 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
25.0%
3/12 • Number of events 3 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
7.7%
1/13 • Number of events 1 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
0.00%
0/12 • Unsolicited AEs were collected for 30 days, while solicited AEs (reactogenicity) were monitored for 7 days after each study product administration. SAEs, MAAEs, AESIs, and AEs causing withdrawal were tracked for twelve months post-vaccination (up to 104 weeks). The Solicited AEs (Reactogenicity) assessment was collected through 7 full days after each vaccination.
|
Additional Information
Jaessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place