Trial Outcomes & Findings for A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya (NCT NCT04826094)
NCT ID: NCT04826094
Last Updated: 2025-03-26
Results Overview
Incidence (number and percentage of participants) of local reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
143 participants
Primary outcome timeframe
Day 1-Day 7 Post Vaccination 1
Results posted on
2025-03-26
Participant Flow
See protocol for screening details.
Participant milestones
| Measure |
Group 1: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 2: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 3: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
dmLT: Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
|
Group 4: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
dmLT: Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
|
Group 5: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 6: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 7: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Pooled Placebo
Pooled placebo arm.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
17
|
16
|
16
|
18
|
17
|
26
|
|
Overall Study
COMPLETED
|
13
|
14
|
15
|
15
|
13
|
12
|
14
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
1
|
3
|
6
|
3
|
6
|
Reasons for withdrawal
| Measure |
Group 1: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 2: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 3: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
dmLT: Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
|
Group 4: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
dmLT: Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
|
Group 5: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 6: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Group 7: Vaccine
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Env-C Plasmid DNA: 2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 protein: 100 µg per dose. Administered by intramuscular injection.
Rehydragel®: Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43: Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
Placebo (IM): 0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
|
Pooled Placebo
Pooled placebo arm.
Placebo (TCl): Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
1
|
3
|
1
|
1
|
|
Overall Study
Participant withdrew consent
|
1
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Non-adherence (protocol deviation)
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawn by Investigator
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Other: Moved from area
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other: Declined
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other: Vaccine not administered
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
3
|
Baseline Characteristics
All Randomized Participants
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=17 Participants
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 2: Vaccine
n=16 Participants
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 3: Vaccine
n=17 Participants
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 4: Vaccine
n=16 Participants
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 5: Vaccine
n=16 Participants
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 6: Vaccine
n=18 Participants
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 7: Vaccine
n=17 Participants
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Pooled Placebo
n=26 Participants
Pooled placebo arm.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Level of Education
Secondary school not completed
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
|
Age, Continuous
Age Years
|
26.4 years
STANDARD_DEVIATION 3.7 • n=5 Participants • All Randomized Participants
|
26.6 years
STANDARD_DEVIATION 5.3 • n=7 Participants • All Randomized Participants
|
29.0 years
STANDARD_DEVIATION 4.5 • n=5 Participants • All Randomized Participants
|
27.2 years
STANDARD_DEVIATION 5.9 • n=4 Participants • All Randomized Participants
|
29.2 years
STANDARD_DEVIATION 5.0 • n=21 Participants • All Randomized Participants
|
28.8 years
STANDARD_DEVIATION 5.2 • n=8 Participants • All Randomized Participants
|
28.7 years
STANDARD_DEVIATION 3.9 • n=8 Participants • All Randomized Participants
|
28.7 years
STANDARD_DEVIATION 6.0 • n=24 Participants • All Randomized Participants
|
28.1 years
STANDARD_DEVIATION 5.0 • n=42 Participants • All Randomized Participants
|
|
Age, Customized
18-25
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
49 Participants
n=42 Participants
|
|
Age, Customized
26-30
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
Age, Customized
31-35
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
|
Age, Customized
36-40
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
86 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
57 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
143 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
143 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
BMI
|
24.05 kg/m2
STANDARD_DEVIATION 5.13 • n=5 Participants
|
22.49 kg/m2
STANDARD_DEVIATION 4.73 • n=7 Participants
|
23.95 kg/m2
STANDARD_DEVIATION 3.84 • n=5 Participants
|
21.87 kg/m2
STANDARD_DEVIATION 2.92 • n=4 Participants
|
21.31 kg/m2
STANDARD_DEVIATION 3.30 • n=21 Participants
|
22.00 kg/m2
STANDARD_DEVIATION 3.09 • n=8 Participants
|
22.65 kg/m2
STANDARD_DEVIATION 3.76 • n=8 Participants
|
24.37 kg/m2
STANDARD_DEVIATION 5.27 • n=24 Participants
|
22.95 kg/m2
STANDARD_DEVIATION 4.23 • n=42 Participants
|
|
Tribe
Kalenjin
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
121 Participants
n=42 Participants
|
|
Tribe
Kisii
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Tribe
Luhya
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Tribe
Luo
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Tribe
Kikuyu
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Tribe
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Tribe
Refuse to answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Marital Status
Single, never married
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
53 Participants
n=42 Participants
|
|
Marital Status
Married or living as a couple
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
84 Participants
n=42 Participants
|
|
Marital Status
Divorced / Separated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Marital Status
Married but living apart
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Level of Education
No formal education
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Level of Education
Primary school not completed
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
43 Participants
n=42 Participants
|
|
Level of Education
Primary school completed
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
|
Level of Education
Secondary school completed
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
|
Level of Education
College/university
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
|
Level of Education
Advanced degree
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Primary Occupation
Student
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Primary Occupation
Housewife
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Primary Occupation
Personal or domestic services
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Primary Occupation
Unskilled laborer
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Primary Occupation
Farmer
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
53 Participants
n=42 Participants
|
|
Primary Occupation
Entertainment/Services/Hospitality
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Primary Occupation
Skilled trade (tailor, hairdresser, etc.)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Primary Occupation
Professional/managerial
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Primary Occupation
Commerce/business
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Primary Occupation
Sex worker
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Primary Occupation
Fisher/Fish trader
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Primary Occupation
Truck driver
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Primary Occupation
Military officer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Primary Occupation
Military enlisted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Primary Occupation
Refuse to answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Primary Occupation
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 1Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of local reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=33 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=32 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=33 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=16 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=23 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=114 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Redness/Erythema · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Any Solicited Local Reactogenicity Event · None
|
23 Participants
|
27 Participants
|
25 Participants
|
10 Participants
|
20 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Any Solicited Local Reactogenicity Event · Mild (Grade 1)
|
8 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Any Solicited Local Reactogenicity Event · Moderate (Grade 2)
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Any Solicited Local Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Any Solicited Local Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Pain/Tenderness · None
|
27 Participants
|
28 Participants
|
26 Participants
|
12 Participants
|
20 Participants
|
93 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Pain/Tenderness · Mild (Grade 1)
|
5 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Pain/Tenderness · Moderate (Grade 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Pain/Tenderness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Pain/Tenderness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Itching · None
|
29 Participants
|
30 Participants
|
32 Participants
|
14 Participants
|
23 Participants
|
105 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Itching · Mild (Grade 1)
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Itching · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Itching · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Itching · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Warmth · None
|
28 Participants
|
32 Participants
|
33 Participants
|
14 Participants
|
22 Participants
|
107 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Warmth · Mild (Grade 1)
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Warmth · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Warmth · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Warmth · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Swelling/Induration · None
|
33 Participants
|
31 Participants
|
32 Participants
|
15 Participants
|
23 Participants
|
111 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Swelling/Induration · Mild (Grade 1)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Swelling/Induration · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Swelling/Induration · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Swelling/Induration · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Redness/Erythema · None
|
32 Participants
|
32 Participants
|
31 Participants
|
15 Participants
|
23 Participants
|
110 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Redness/Erythema · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Redness/Erythema · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Redness/Erythema · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Hardness · None
|
33 Participants
|
30 Participants
|
33 Participants
|
15 Participants
|
23 Participants
|
111 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Hardness · Mild (Grade 1)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Hardness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Hardness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Hardness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 2Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of local reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=30 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=25 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=31 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=15 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=101 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Warmth · Mild (Grade 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Any Solicited Local Reactogenicity Event · Mild (Grade 1)
|
4 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Any Solicited Local Reactogenicity Event · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Any Solicited Local Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Any Solicited Local Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Pain/Tenderness · None
|
27 Participants
|
19 Participants
|
28 Participants
|
11 Participants
|
19 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Pain/Tenderness · Mild (Grade 1)
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Pain/Tenderness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Pain/Tenderness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Pain/Tenderness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Itching · None
|
29 Participants
|
23 Participants
|
28 Participants
|
13 Participants
|
20 Participants
|
93 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Itching · Mild (Grade 1)
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Itching · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Itching · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Itching · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Warmth · None
|
30 Participants
|
24 Participants
|
31 Participants
|
14 Participants
|
19 Participants
|
99 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Warmth · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Warmth · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Warmth · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Swelling/Induration · None
|
30 Participants
|
24 Participants
|
31 Participants
|
13 Participants
|
20 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Swelling/Induration · Mild (Grade 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Swelling/Induration · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Swelling/Induration · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Swelling/Induration · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Redness/Erythema · None
|
30 Participants
|
25 Participants
|
31 Participants
|
14 Participants
|
20 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Redness/Erythema · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Redness/Erythema · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Redness/Erythema · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Redness/Erythema · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Hardness · None
|
30 Participants
|
25 Participants
|
31 Participants
|
14 Participants
|
20 Participants
|
100 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Hardness · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Hardness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Hardness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Hardness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Any Solicited Local Reactogenicity Event · None
|
26 Participants
|
19 Participants
|
28 Participants
|
11 Participants
|
18 Participants
|
84 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 3Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of local reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group.
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=30 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=24 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=30 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=14 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=98 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Any Solicited Local Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Pain/Tenderness · None
|
25 Participants
|
23 Participants
|
28 Participants
|
14 Participants
|
19 Participants
|
90 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Swelling/Induration · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Hardness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Hardness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Any Solicited Local Reactogenicity Event · None
|
25 Participants
|
23 Participants
|
26 Participants
|
14 Participants
|
19 Participants
|
88 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Hardness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Any Solicited Local Reactogenicity Event · Mild (Grade 1)
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Any Solicited Local Reactogenicity Event · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Any Solicited Local Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Pain/Tenderness · Mild (Grade 1)
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Pain/Tenderness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Pain/Tenderness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Pain/Tenderness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Itching · None
|
28 Participants
|
24 Participants
|
30 Participants
|
14 Participants
|
20 Participants
|
96 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Itching · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Itching · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Itching · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Itching · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Warmth · None
|
29 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
96 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Warmth · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Warmth · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Warmth · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Warmth · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Swelling/Induration · None
|
30 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Swelling/Induration · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Swelling/Induration · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Swelling/Induration · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Redness/Erythema · None
|
30 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Redness/Erythema · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Redness/Erythema · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Redness/Erythema · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Redness/Erythema · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Hardness · None
|
30 Participants
|
24 Participants
|
30 Participants
|
14 Participants
|
20 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Hardness · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 4Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of local reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=15 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=14 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=16 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=14 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=15 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=15 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=15 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=104 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Pain/Tenderness · None
|
8 Participants
|
12 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
14 Participants
|
15 Participants
|
18 Participants
|
80 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Any Solicited Local Reactogenicity Event · None
|
8 Participants
|
12 Participants
|
9 Participants
|
9 Participants
|
12 Participants
|
14 Participants
|
15 Participants
|
18 Participants
|
79 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Any Solicited Local Reactogenicity Event · Mild (Grade 1)
|
6 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
23 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Any Solicited Local Reactogenicity Event · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Any Solicited Local Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Any Solicited Local Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Pain/Tenderness · Mild (Grade 1)
|
6 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
22 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Pain/Tenderness · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Pain/Tenderness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Pain/Tenderness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Itching · None
|
12 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
19 Participants
|
100 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Itching · Mild (Grade 1)
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Itching · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Itching · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Itching · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Warmth · None
|
14 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
100 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Warmth · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Warmth · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Warmth · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Warmth · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Swelling/Induration · None
|
13 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
101 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Swelling/Induration · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Swelling/Induration · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Swelling/Induration · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Swelling/Induration · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Redness/Erythema · None
|
14 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
102 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Redness/Erythema · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Redness/Erythema · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Redness/Erythema · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Redness/Erythema · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Hardness · None
|
15 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
104 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Hardness · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Hardness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Hardness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Hardness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 5Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of local reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=12 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=14 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=13 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=15 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=14 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=15 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=14 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=21 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=97 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Pain/Tenderness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Warmth · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Redness/Erythema · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Itching · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Itching · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Any Solicited Local Reactogenicity Event · None
|
10 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
20 Participants
|
86 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Any Solicited Local Reactogenicity Event · Mild (Grade 1)
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Any Solicited Local Reactogenicity Event · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Any Solicited Local Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Any Solicited Local Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Pain/Tenderness · None
|
10 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
20 Participants
|
87 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Pain/Tenderness · Mild (Grade 1)
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Pain/Tenderness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Pain/Tenderness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Itching · None
|
11 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
96 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Itching · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Itching · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Warmth · None
|
12 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
96 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Warmth · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Warmth · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Warmth · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Swelling/Induration · None
|
12 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
96 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Swelling/Induration · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Swelling/Induration · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Swelling/Induration · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Swelling/Induration · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Redness/Erythema · None
|
12 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
96 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Redness/Erythema · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Redness/Erythema · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Redness/Erythema · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Hardness · None
|
11 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
96 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Hardness · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Hardness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Hardness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Hardness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 6Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of local reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=12 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=14 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=12 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=15 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=15 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=15 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=14 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=97 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Any Solicited Local Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Any Solicited Local Reactogenicity Event · None
|
9 Participants
|
13 Participants
|
11 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
20 Participants
|
88 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Any Solicited Local Reactogenicity Event · Mild (Grade 1)
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Any Solicited Local Reactogenicity Event · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Any Solicited Local Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Pain/Tenderness · None
|
11 Participants
|
13 Participants
|
11 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
91 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Pain/Tenderness · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Pain/Tenderness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Pain/Tenderness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Pain/Tenderness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Itching · None
|
10 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
20 Participants
|
94 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Itching · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Itching · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Itching · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Itching · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Warmth · None
|
11 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
20 Participants
|
95 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Warmth · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Warmth · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Warmth · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Warmth · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Swelling/Induration · None
|
11 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
95 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Swelling/Induration · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Swelling/Induration · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Swelling/Induration · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Swelling/Induration · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Redness/Erythema · None
|
12 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
97 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Redness/Erythema · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Redness/Erythema · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Redness/Erythema · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Redness/Erythema · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Hardness · None
|
12 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
96 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Hardness · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Hardness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Hardness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Hardness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 1Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=33 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=32 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=33 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=16 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=23 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=114 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Nausea · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Dizziness · Mild (Grade 1)
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Any Solicited Systemic Reactogenicity Event · None
|
17 Participants
|
21 Participants
|
16 Participants
|
8 Participants
|
12 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Any Solicited Systemic Reactogenicity Event · Mild (Grade 1)
|
14 Participants
|
10 Participants
|
17 Participants
|
6 Participants
|
11 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Any Solicited Systemic Reactogenicity Event · Moderate (Grade 2)
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Any Solicited Systemic Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Any Solicited Systemic Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fever · None
|
31 Participants
|
31 Participants
|
33 Participants
|
13 Participants
|
21 Participants
|
108 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fever · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fever · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fever · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fever · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fatigue/Tiredness · None
|
21 Participants
|
26 Participants
|
26 Participants
|
11 Participants
|
17 Participants
|
84 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fatigue/Tiredness · Mild (Grade 1)
|
11 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
29 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fatigue/Tiredness · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fatigue/Tiredness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Fatigue/Tiredness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Myalgia · None
|
28 Participants
|
29 Participants
|
32 Participants
|
14 Participants
|
20 Participants
|
103 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Myalgia · Mild (Grade 1)
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Myalgia · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Myalgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Myalgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Arthralgia · None
|
30 Participants
|
27 Participants
|
31 Participants
|
14 Participants
|
20 Participants
|
102 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Arthralgia · Mild (Grade 1)
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Arthralgia · Moderate (Grade 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Arthralgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Arthralgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Headache · None
|
19 Participants
|
23 Participants
|
20 Participants
|
11 Participants
|
12 Participants
|
73 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Headache · Mild (Grade 1)
|
13 Participants
|
8 Participants
|
13 Participants
|
5 Participants
|
11 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Headache · Moderate (Grade 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Headache · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Headache · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Chills · None
|
29 Participants
|
27 Participants
|
32 Participants
|
14 Participants
|
20 Participants
|
102 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Chills · Mild (Grade 1)
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Chills · Moderate (Grade 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Chills · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Chills · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Rash · None
|
33 Participants
|
32 Participants
|
32 Participants
|
16 Participants
|
23 Participants
|
113 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Rash · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Rash · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Rash · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Rash · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Nausea · None
|
32 Participants
|
31 Participants
|
32 Participants
|
13 Participants
|
21 Participants
|
108 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Nausea · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Nausea · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Nausea · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Dizziness · None
|
27 Participants
|
27 Participants
|
30 Participants
|
13 Participants
|
20 Participants
|
97 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Dizziness · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Dizziness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Dizziness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 2Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=30 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=25 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=31 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=15 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=101 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fever · None
|
30 Participants
|
24 Participants
|
28 Participants
|
12 Participants
|
20 Participants
|
94 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Myalgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Any Solicited Systemic Reactogenicity Event · None
|
22 Participants
|
17 Participants
|
25 Participants
|
9 Participants
|
15 Participants
|
73 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Any Solicited Systemic Reactogenicity Event · Mild (Grade 1)8
|
8 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Any Solicited Systemic Reactogenicity Event · Moderate (Grade 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Any Solicited Systemic Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Any Solicited Systemic Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fever · Mild (Grade 1)8
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fever · Moderate (Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fever · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fever · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fatigue/Tiredness · None
|
27 Participants
|
22 Participants
|
30 Participants
|
13 Participants
|
17 Participants
|
92 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fatigue/Tiredness · Mild (Grade 1)8
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fatigue/Tiredness · Moderate (Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fatigue/Tiredness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Fatigue/Tiredness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Myalgia · None
|
29 Participants
|
21 Participants
|
31 Participants
|
14 Participants
|
19 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Myalgia · Mild (Grade 1)8
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Myalgia · Moderate (Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Myalgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Arthralgia · None
|
28 Participants
|
23 Participants
|
31 Participants
|
14 Participants
|
19 Participants
|
96 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Arthralgia · Mild (Grade 1)8
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Arthralgia · Moderate (Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Arthralgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Arthralgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Chills · None
|
28 Participants
|
22 Participants
|
30 Participants
|
14 Participants
|
19 Participants
|
94 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Chills · Mild (Grade 1)8
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Chills · Moderate (Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Chills · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Chills · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Headache · None
|
22 Participants
|
21 Participants
|
30 Participants
|
13 Participants
|
17 Participants
|
86 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Headache · Mild (Grade 1)8
|
8 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Headache · Moderate (Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Headache · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Headache · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Rash · None
|
29 Participants
|
24 Participants
|
31 Participants
|
14 Participants
|
20 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Rash · Mild (Grade 1)8
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Rash · Moderate (Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Rash · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Rash · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Nausea · None
|
28 Participants
|
23 Participants
|
31 Participants
|
14 Participants
|
18 Participants
|
96 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Nausea · Mild (Grade 1)8
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Nausea · Moderate (Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Nausea · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Nausea · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Dizziness · None
|
27 Participants
|
23 Participants
|
30 Participants
|
14 Participants
|
20 Participants
|
94 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Dizziness · Mild (Grade 1)8
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Dizziness · Moderate (Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Dizziness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Dizziness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 3Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=30 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=24 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=30 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=14 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=98 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Myalgia · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Any Solicited Systemic Reactogenicity Event · None
|
20 Participants
|
21 Participants
|
26 Participants
|
12 Participants
|
18 Participants
|
79 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Any Solicited Systemic Reactogenicity Event · Mild (Grade 1)
|
9 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Any Solicited Systemic Reactogenicity Event · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Any Solicited Systemic Reactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Any Solicited Systemic Reactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fever · None
|
29 Participants
|
23 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fever · Mild (Grade 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fever · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fever · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fever · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fatigue/Tiredness · None
|
26 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
93 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fatigue/Tiredness · Mild (Grade 1)
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fatigue/Tiredness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fatigue/Tiredness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Fatigue/Tiredness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Arthralgia · None
|
29 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
96 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Arthralgia · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Arthralgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Arthralgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Arthralgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Myalgia · None
|
29 Participants
|
24 Participants
|
29 Participants
|
13 Participants
|
20 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Myalgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Myalgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Myalgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Headache · None
|
22 Participants
|
22 Participants
|
28 Participants
|
12 Participants
|
18 Participants
|
84 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Headache · Mild (Grade 1)
|
8 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Headache · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Headache · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Headache · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Chills · None
|
28 Participants
|
24 Participants
|
30 Participants
|
13 Participants
|
19 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Chills · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Chills · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Chills · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Chills · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Rash · None
|
30 Participants
|
24 Participants
|
30 Participants
|
14 Participants
|
20 Participants
|
98 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Rash · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Rash · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Rash · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Rash · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Nausea · None
|
29 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
96 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Nausea · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Nausea · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Nausea · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Nausea · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Dizziness · None
|
28 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
20 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Dizziness · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Dizziness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Dizziness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Dizziness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 4Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=15 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=14 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=16 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=14 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=15 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=15 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=15 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=104 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Chills · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · None
|
8 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
16 Participants
|
79 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Mild (Grade 1)
|
7 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
21 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fever · None
|
12 Participants
|
14 Participants
|
16 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
20 Participants
|
94 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fever · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fever · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fever · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fever · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fatigue/Tiredness · None
|
14 Participants
|
13 Participants
|
16 Participants
|
13 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
19 Participants
|
101 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fatigue/Tiredness · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fatigue/Tiredness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fatigue/Tiredness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Fatigue/Tiredness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Myalgia · None
|
13 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
99 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Myalgia · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Myalgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Myalgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Myalgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Arthralgia · None
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
19 Participants
|
102 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Arthralgia · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Arthralgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Arthralgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Arthralgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Headache · None
|
10 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
90 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Headache · Mild (Grade 1)
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Headache · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Headache · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Headache · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Chills · None
|
15 Participants
|
13 Participants
|
16 Participants
|
12 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
100 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Chills · Mild (Grade 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Chills · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Chills · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Rash · None
|
15 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
104 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Rash · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Rash · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Rash · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Rash · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Nausea · None
|
14 Participants
|
13 Participants
|
16 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
102 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Nausea · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Nausea · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Nausea · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Nausea · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Dizziness · None
|
13 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
20 Participants
|
101 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Dizziness · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Dizziness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Dizziness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Dizziness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 5Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=12 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=14 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=13 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=15 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=14 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=15 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=14 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=21 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=97 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Nausea · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fatigue/Tiredness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fatigue/Tiredness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Myalgia · None
|
11 Participants
|
13 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
21 Participants
|
93 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Myalgia · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Myalgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Myalgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Myalgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Arthralgia · None
|
12 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
96 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Arthralgia · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Arthralgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Arthralgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Arthralgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Headache · None
|
8 Participants
|
11 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
19 Participants
|
87 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Headache · Mild (Grade 1)
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Headache · Moderate (Grade 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Headache · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Headache · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Chills · None
|
11 Participants
|
12 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
93 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Chills · Mild (Grade 1)
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Chills · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Chills · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Chills · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Rash · None
|
12 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
97 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Rash · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Rash · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Rash · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Rash · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Nausea · None
|
11 Participants
|
13 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
93 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Nausea · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Nausea · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Nausea · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Dizziness · None
|
11 Participants
|
10 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
21 Participants
|
91 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Dizziness · Mild (Grade 1)
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Dizziness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Dizziness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Dizziness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · None
|
8 Participants
|
9 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
12 Participants
|
16 Participants
|
82 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Mild (Grade 1)
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
13 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Moderate (Grade 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fever · None
|
10 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
17 Participants
|
93 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fever · Mild (Grade 1)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fever · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fever · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fever · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fatigue/Tiredness · None
|
10 Participants
|
11 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
20 Participants
|
91 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fatigue/Tiredness · Mild (Grade 1)
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Fatigue/Tiredness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 7 Post Vaccination 6Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=12 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=14 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=12 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=15 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=15 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=15 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=14 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=20 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=97 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Nausea · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · None
|
8 Participants
|
12 Participants
|
9 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
13 Participants
|
16 Participants
|
79 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Mild (Grade 1)
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Any Solicited Systemic Reactogenicity EventReactogenicity Event · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fever · None
|
10 Participants
|
13 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
20 Participants
|
91 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fever · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fever · Moderate (Grade 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fever · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fever · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fatigue/Tiredness · None
|
12 Participants
|
14 Participants
|
11 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
18 Participants
|
95 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fatigue/Tiredness · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fatigue/Tiredness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fatigue/Tiredness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Fatigue/Tiredness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Myalgia · None
|
12 Participants
|
14 Participants
|
10 Participants
|
15 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
93 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Myalgia · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Myalgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Myalgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Myalgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Arthralgia · None
|
12 Participants
|
14 Participants
|
11 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
95 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Arthralgia · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Arthralgia · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Arthralgia · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Arthralgia · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Headache · None
|
11 Participants
|
13 Participants
|
9 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
17 Participants
|
89 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Headache · Mild (Grade 1)
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Headache · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Headache · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Headache · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Chills · None
|
11 Participants
|
14 Participants
|
10 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
93 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Chills · Mild (Grade 1)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Dizziness · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Chills · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Chills · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Chills · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Rash · None
|
12 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
97 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Rash · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Rash · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Rash · Severe (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Rash · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Nausea · None
|
12 Participants
|
13 Participants
|
12 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
20 Participants
|
94 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Nausea · Mild (Grade 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Nausea · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Nausea · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Dizziness · None
|
12 Participants
|
14 Participants
|
10 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
94 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Dizziness · Mild (Grade 1)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Dizziness · Moderate (Grade 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Dizziness · Potentially Life-Threatening (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1-Day 728Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of related unsolicited AEs by maximum severity and vaccination group.
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=33 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=17 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=16 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=32 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=16 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=16 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=33 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=16 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=17 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
n=16 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
n=23 Participants
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Related Unsolicited AEs (Outcome 13)
Mild Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Related Unsolicited AEs (Outcome 13)
Moderate / Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Related Unsolicited AEs (Outcome 13)
Severe / Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Related Unsolicited AEs (Outcome 13)
Potentially Life-Threatening / Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Related Unsolicited AEs (Outcome 13)
None
|
32 Participants
|
16 Participants
|
16 Participants
|
32 Participants
|
16 Participants
|
16 Participants
|
32 Participants
|
15 Participants
|
17 Participants
|
16 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Day 1-Day 728Population: The safety population includes all participants who received at least one vaccination.
Incidence (number and percentage of participants) of SAEs by maximum severity and vaccination group
Outcome measures
| Measure |
Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone
n=33 Participants
Priming Dose Group 1: Prime of Env-C Plasmid DNA alone
|
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
n=17 Participants
Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT
|
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
n=16 Participants
Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein
n=32 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 protein
|
Pooled Placebo
n=16 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=16 Participants
All Participants Receiving Env-C Plasmid DNA
|
Group 7:
n=33 Participants
Group 7: Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 + Env-C Plasmid DNA / HIV Env gp145 C.6980 protein / ALF43 / Rehydragel®
|
Pooled Placebo
n=16 Participants
Pooled Placebo
|
All Participants Receiving Env-C Plasmid DNA
n=17 Participants
All Participants Receiving Env-C Plasmid DNA
|
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 Protein (Group 7)
n=16 Participants
Priming Dose Group 4: Prime of Env-C Plasmid DNA / dmLT / HIV Env gp145 C.6980 protein (Group 7)
|
Pooled Placebo
n=23 Participants
Pooled Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of SAEs (Outcome 14)
Mild Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of SAEs (Outcome 14)
Moderate / Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of SAEs (Outcome 14)
Severe / Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of SAEs (Outcome 14)
Potentially Life-Threatening / Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of SAEs (Outcome 14)
None
|
32 Participants
|
16 Participants
|
16 Participants
|
32 Participants
|
16 Participants
|
16 Participants
|
33 Participants
|
16 Participants
|
17 Participants
|
16 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Thru Week 105Measured by binding antibody assays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Measured by binding antibody assays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Measured by binding antibody assays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Measured by binding antibody assays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Measured by binding antibody assays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Measured by binding antibody assays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 105Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Thru Week 104Including, but not limited to, plasma IgG and IgA binding antibodies to HIV Env proteins, IgG and IgA subclass, and functional assays.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Vaccine
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 3: Vaccine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group 4: Vaccine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 5: Vaccine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 6: Vaccine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 7: Vaccine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Vaccine
n=17 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 2: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 3: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 4: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 5: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 6: Vaccine
n=17 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 7: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Pooled Placebo
n=23 participants at risk
Pooled placebo arm.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
Other adverse events
| Measure |
Group 1: Vaccine
n=17 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 2: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 3: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 4: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 5: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 6: Vaccine
n=17 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Group 7: Vaccine
n=16 participants at risk
3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
|
Pooled Placebo
n=23 participants at risk
Pooled placebo arm.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 5 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Blood and lymphatic system disorders
Leukopenias NEC
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.6%
3/17 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Endocrine disorders
Graves' disease
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Gastritis
|
17.6%
3/17 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
17.6%
3/17 • Number of events 5 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
17.4%
4/23 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Haematochezia
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
General disorders
Toothache
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
General disorders
Chest pain
|
11.8%
2/17 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
8.7%
2/23 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
General disorders
Chills
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
General disorders
Swelling
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
General disorders
Tenderness
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Bacterial vaginosis
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Extrapulmonary tuberculosis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
11.8%
2/17 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Helicobacter infection
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Malaria
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Septic rash
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Tonsillitis
|
17.6%
3/17 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
37.5%
6/16 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Upper respiratory tract infection
|
29.4%
5/17 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
62.5%
10/16 • Number of events 12 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
25.0%
4/16 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
37.5%
6/16 • Number of events 9 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
31.2%
5/16 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
23.5%
4/17 • Number of events 5 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
25.0%
4/16 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
13.0%
3/23 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
13.0%
3/23 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Wound infection
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
31.2%
5/16 • Number of events 5 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
17.4%
4/23 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Investigations
International normalised ratio increased
|
11.8%
2/17 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
8.7%
2/23 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Investigations
Prothrombin time prolonged
|
23.5%
4/17 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
13.0%
3/23 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Investigations
White blood cell count decreased
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
13.0%
3/23 • Number of events 3 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
8.7%
2/23 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
11.8%
2/17 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
37.5%
6/16 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
25.0%
4/16 • Number of events 6 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
18.8%
3/16 • Number of events 5 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
23.5%
4/17 • Number of events 4 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
8.7%
2/23 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Reproductive system and breast disorders
Ovarian disorder
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
5.9%
1/17 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
4.3%
1/23 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
6.2%
1/16 • Number of events 1 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
12.5%
2/16 • Number of events 2 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/17 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/16 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
0.00%
0/23 • AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.
ICH E6 defines an AE as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. FDA defines an AE as any untoward medical occurrence associated with the use of a drug in humans, whether considered drug related.
|
Additional Information
David Fetterer, MS (Programmer Analyst)
Henry M Jackson Foundation for the Advancement of Military Medicine
Phone: 301.500.3818
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place