Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the rSm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar (NCT NCT05762393)
NCT ID: NCT05762393
Last Updated: 2026-04-29
Results Overview
Serious Adverse Events (SAE) An AE or suspected adverse reaction is considered "serious" if at any dose (including overdose): Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect ; or Is an important medical event that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. Adverse Event of Special Interest (AESI) are AEs that are considered by the sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
Day 1 through Day 224
Results posted on
2026-04-29
Participant Flow
The Study population includes 120 healthy adults ages 20 through 59 years who met all eligibility criteria (60 participants per site). Participants were enrolled between 17 Nov 2023 to 11 Oct 2024.
Participant milestones
| Measure |
Placebo Group
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Group
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
|---|---|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.50 years
STANDARD_DEVIATION 12.42 • n=30 Participants
|
32.37 years
STANDARD_DEVIATION 9.80 • n=30 Participants
|
34.80 years
STANDARD_DEVIATION 10.52 • n=30 Participants
|
35.13 years
STANDARD_DEVIATION 11.33 • n=30 Participants
|
34.70 years
STANDARD_DEVIATION 11.02 • n=120 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=30 Participants
|
21 Participants
n=30 Participants
|
21 Participants
n=30 Participants
|
21 Participants
n=30 Participants
|
82 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
38 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Burkina Faso
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
60 Participants
n=120 Participants
|
|
Region of Enrollment
Madagascar
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
60 Participants
n=120 Participants
|
|
Height
|
162.11 cm
STANDARD_DEVIATION 6.99 • n=30 Participants
|
161.54 cm
STANDARD_DEVIATION 8.43 • n=30 Participants
|
161.05 cm
STANDARD_DEVIATION 7.99 • n=30 Participants
|
161.41 cm
STANDARD_DEVIATION 10.71 • n=30 Participants
|
161.53 cm
STANDARD_DEVIATION 8.54 • n=120 Participants
|
|
Weight
|
56.90 kg
STANDARD_DEVIATION 11.48 • n=30 Participants
|
61.00 kg
STANDARD_DEVIATION 10.19 • n=30 Participants
|
54.92 kg
STANDARD_DEVIATION 10.84 • n=30 Participants
|
58.99 kg
STANDARD_DEVIATION 11.32 • n=30 Participants
|
57.95 kg
STANDARD_DEVIATION 11.07 • n=120 Participants
|
|
BMI
|
21.73 kg/m^2
STANDARD_DEVIATION 4.71 • n=30 Participants
|
23.43 kg/m^2
STANDARD_DEVIATION 4.03 • n=30 Participants
|
20.98 kg/m^2
STANDARD_DEVIATION 2.71 • n=30 Participants
|
22.58 kg/m^2
STANDARD_DEVIATION 3.16 • n=30 Participants
|
22.18 kg/m^2
STANDARD_DEVIATION 3.80 • n=120 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 224Population: The safety population includes all participants who received at least one dose of the investigational product and is summarized according to the treatment cohort.
Serious Adverse Events (SAE) An AE or suspected adverse reaction is considered "serious" if at any dose (including overdose): Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect ; or Is an important medical event that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. Adverse Event of Special Interest (AESI) are AEs that are considered by the sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Proportion of Participants With of Any Serious Adverse Events (SAEs)/ Adverse Events of Special Interest (AESI) From the Time of the First Study Vaccination Through the Final Study Visit.
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 56Population: The safety population includes all participants who received at least one dose of the investigational product and is summarized according to the treatment cohort.
Immediate adverse events collected within 60 mins from the time of each study vaccination Local (Injection site) reactions collected include Pain, Tenderness, Pruritus (itching), Swelling, Erythema (Redness) and Induration (Hardness). Systemic symptoms collected include Chills, Myalgia (Body aches/Muscular pain), Arthralgia (Joint pain), Nausea, Vomiting, Headache, Dizziness, Malaise, Fatigue. Quantitative data regarding fever as a systemic reactogenicity parameter were collected.
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Proportion of Participants With Immediate Adverse Events (Reactogenicity Events) Within 60 Min From the Time of Each Study Vaccination
Post Dose 1
|
6 Participants
|
11 Participants
|
6 Participants
|
2 Participants
|
|
Proportion of Participants With Immediate Adverse Events (Reactogenicity Events) Within 60 Min From the Time of Each Study Vaccination
Post Dose 2
|
6 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
|
Proportion of Participants With Immediate Adverse Events (Reactogenicity Events) Within 60 Min From the Time of Each Study Vaccination
Post Dose 3
|
7 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 63Population: The safety population includes all participants who received at least one dose of the investigational product and is summarized according to the treatment cohort.
Local (Injection site) reactions collected include Pain, Tenderness, Pruritus (itching), Swelling, Erythema (Redness) and Induration (Hardness). Systemic symptoms collected include Chills, Myalgia (Body aches/Muscular pain), Arthralgia (Joint pain), Nausea, Vomiting, Headache, Dizziness, Malaise, Fatigue. Quantitative data regarding fever as a systemic reactogenicity parameter were collected.
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Proportion of Participants With Solicited Local and Solicited Systemic AEs as Measured for 7 Days (Inclusive) Following Immunization With the Three Different Dose Formulations.
Post Dose 3
|
9 Participants
|
9 Participants
|
3 Participants
|
1 Participants
|
|
Proportion of Participants With Solicited Local and Solicited Systemic AEs as Measured for 7 Days (Inclusive) Following Immunization With the Three Different Dose Formulations.
Post Dose 1
|
16 Participants
|
10 Participants
|
7 Participants
|
4 Participants
|
|
Proportion of Participants With Solicited Local and Solicited Systemic AEs as Measured for 7 Days (Inclusive) Following Immunization With the Three Different Dose Formulations.
Post Dose 2
|
10 Participants
|
16 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 84Population: The safety population includes all participants who received at least one dose of the investigational product and is summarized according to the treatment cohort.
Unsolicited adverse events (AEs) were defined as an untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Proportion of Participants With Unsolicited AEs From the Time of Vaccination Until 28 Days Post Immunization With the Three Different Dose Formulations.
Post Dose 1
|
9 Participants
|
8 Participants
|
8 Participants
|
13 Participants
|
|
Proportion of Participants With Unsolicited AEs From the Time of Vaccination Until 28 Days Post Immunization With the Three Different Dose Formulations.
Post Dose 2
|
9 Participants
|
10 Participants
|
7 Participants
|
11 Participants
|
|
Proportion of Participants With Unsolicited AEs From the Time of Vaccination Until 28 Days Post Immunization With the Three Different Dose Formulations.
Post Dose 3
|
6 Participants
|
10 Participants
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 84Population: The safety population includes all participants who received at least one dose of the investigational product and is summarized according to the treatment cohort.
Clinical laboratory safety measurements collected include: Hematology \[Complete blood count (CBC) with automated differential\]: White blood cell (WBC) count, Red Blood Cell count (RBC), hemoglobin, and platelet count. Serum chemistry: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST), Total Bilirubin (TB), Creatinine (CREAT), and C-reactive protein (CRP). Urine samples were be tested by dipstick for blood, glucose and protein. Labs samples were collected at screening and on vaccination days and 7 days and 28 days post each vaccination.
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
7 Days post Dose 1
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
28 Days post Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
7 Days post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
7 Days post Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
28 Days post Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Clinical Safety Laboratory Adverse Events Measured at 7 Days and 28 Days After Each Study Vaccination.
28 Days post Dose 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 28 days after the first, second, and third study vaccinationsSeroconversion was defined as a fourfold rise from baseline.
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
For Sm-p80 IgG Antibodies, Seroconversion Rate at Approximately 4 Weeks (28 Days) After Each Dose of Study Vaccination as Compared to Baseline
Day 28 post dose 1
|
1 Participants
|
9 Participants
|
12 Participants
|
0 Participants
|
|
For Sm-p80 IgG Antibodies, Seroconversion Rate at Approximately 4 Weeks (28 Days) After Each Dose of Study Vaccination as Compared to Baseline
Day 28 post dose 2
|
20 Participants
|
28 Participants
|
29 Participants
|
4 Participants
|
|
For Sm-p80 IgG Antibodies, Seroconversion Rate at Approximately 4 Weeks (28 Days) After Each Dose of Study Vaccination as Compared to Baseline
Day 28 post dose 3
|
23 Participants
|
28 Participants
|
29 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Through 24 weeks after third dose of study vaccinationSeroconversion was defined as a fourfold rise from baseline.
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
For Sm-p80 IgG Antibodies, Seroconversion Rate at Approximately 24 Weeks After Third Dose of Study Vaccination as Compared to Baseline
|
25 Participants
|
25 Participants
|
23 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Through 28 days after the first, second, and third study vaccinationsGeometric mean titers (GMTs).
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies at Approximately 4 Weeks After Each Dose of Study Vaccination.
Day 28 post dose 1
|
75.79 titer of serum antibodies
Interval 63.64 to 90.25
|
144.73 titer of serum antibodies
Interval 105.42 to 198.69
|
166.25 titer of serum antibodies
Interval 119.22 to 231.83
|
62.00 titer of serum antibodies
Interval 54.76 to 70.19
|
|
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies at Approximately 4 Weeks After Each Dose of Study Vaccination.
Day 28 post dose 2
|
620.46 titer of serum antibodies
Interval 299.82 to 1283.99
|
2015.87 titer of serum antibodies
Interval 1130.85 to 3593.54
|
1837.92 titer of serum antibodies
Interval 1118.44 to 3020.23
|
91.17 titer of serum antibodies
Interval 70.87 to 117.29
|
|
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies at Approximately 4 Weeks After Each Dose of Study Vaccination.
Day 28 post dose 3
|
1969.83 titer of serum antibodies
Interval 888.64 to 4366.5
|
4422.12 titer of serum antibodies
Interval 2374.16 to 8236.65
|
2425.15 titer of serum antibodies
Interval 1381.16 to 4258.26
|
91.17 titer of serum antibodies
Interval 66.41 to 125.16
|
SECONDARY outcome
Timeframe: Through 24 weeks after third dose of study vaccination.Geometric Mean Titers (GMTs)
Outcome measures
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 Participants
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 Participants
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Sm-p80 IgG Antibodies at Approximately 24 Weeks After Third Dose of Study Vaccination.
|
918.96 titer of serum antibodies
Interval 513.32 to 1645.13
|
857.42 titer of serum antibodies
Interval 492.88 to 1491.57
|
578.91 titer of serum antibodies
Interval 369.31 to 907.45
|
123.11 titer of serum antibodies
Interval 83.74 to 181.0
|
Adverse Events
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 participants at risk
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 participants at risk
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 participants at risk
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 participants at risk
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion Not Otherwise Specified
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Respiratory, thoracic and mediastinal disorders
Febrile Pneumopathy
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
Other adverse events
| Measure |
Cohort A: Low-dose Antigen Group (10 μg rSm-p80 + 5 μg GLA-SE)
n=30 participants at risk
Cohort A consisted of 30 participants who received the low-dose antigen formulation (10 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort B: Medium-dose Antigen Group (30 μg rSm-p80 + 5 μg GLA-SE)
n=30 participants at risk
Cohort B consisted of 30 participants who received the medium-dose antigen formulation (30 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Cohort C: High-dose Antigen Group (100 μg rSm-p80 + 5 μg GLA-SE)
n=30 participants at risk
Cohort C consisted of 30 participants who received the high-dose antigen formulation (100 μg rSm-p80 + 5 μg GLA-SE). Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56 (at 28-day intervals).
|
Placebo Group
n=30 participants at risk
Participants randomized to the placebo group received sterile 0.9% sodium chloride. A total of 30 participants were randomized to this group and evenly distributed across Cohorts A, B, and C. Each participant received three intramuscular injections of 0.5 mL of the assigned study product on Days 0, 28, and 56, administered at 28-day intervals.
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
16.7%
5/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
13.3%
4/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
36.7%
11/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
23.3%
7/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Infections and infestations
Malaria
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
16.7%
5/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
10.0%
3/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Infections and infestations
Rhinitis
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
13.3%
4/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
10.0%
3/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
10.0%
3/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
3/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
3.3%
1/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
6.7%
2/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
0.00%
0/30 • Solicited adverse events (AEs) were collected from the time of each study product vaccination through 7 days after each study product vaccination. Unsolicited AEs were collected from the time of each study product vaccination through 28 days after the study product vaccination. Serious AEs (SAEs) and adverse events of special interest (AESIs) were collected from the time of the first study product vaccination through approximately 6 months after the last study product vaccination.
Adverse events (AE) are defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the administration of the vaccine. An AE may be any unfavorable or unintended sign, symptom, abnormal laboratory finding or disease. Unsolicited AEs are all other adverse events (those that do not fall under the categories of solicited adverse reactions) that are identified by site staff, the PI and the Study Medical Monitor.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER