Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults (NCT NCT02915016)
NCT ID: NCT02915016
Last Updated: 2022-04-29
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
334 participants
Primary outcome timeframe
Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6
Results posted on
2022-04-29
Participant Flow
Participant milestones
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
50
|
50
|
30
|
50
|
50
|
50
|
24
|
|
Overall Study
Month 6.5 Immunogenicity Timepoint
|
23
|
49
|
46
|
26
|
43
|
42
|
42
|
21
|
|
Overall Study
COMPLETED
|
23
|
47
|
42
|
26
|
43
|
44
|
38
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
8
|
4
|
7
|
6
|
12
|
4
|
Reasons for withdrawal
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
5
|
3
|
5
|
2
|
8
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
1
|
3
|
1
|
1
|
|
Overall Study
Elected not to continue
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
HIV infection
|
1
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant unable to adhere
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults
Baseline characteristics by cohort
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
24 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
24 years
n=4 Participants
|
27 years
n=21 Participants
|
25 years
n=8 Participants
|
25 years
n=8 Participants
|
26 years
n=24 Participants
|
25 years
n=42 Participants
|
|
Age, Customized
Less than 18 years
|
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
|
|
Age, Customized
18 - 20 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
49 Participants
n=42 Participants
|
|
Age, Customized
21 - 30 years
|
20 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
233 Participants
n=42 Participants
|
|
Age, Customized
31 - 40 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
52 Participants
n=42 Participants
|
|
Age, Customized
41 - 50 years
|
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
|
|
Age, Customized
Over 50 years
|
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
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
173 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
161 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
308 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
|
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
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
25 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
|
8 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
161 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
134 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
202 Participants
n=42 Participants
|
|
Region of Enrollment
Africa
|
4 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
132 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · None
|
5 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Mild
|
21 Participants
|
20 Participants
|
27 Participants
|
19 Participants
|
24 Participants
|
18 Participants
|
24 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Moderate
|
4 Participants
|
23 Participants
|
17 Participants
|
3 Participants
|
16 Participants
|
27 Participants
|
22 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · None
|
4 Participants
|
8 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Mild
|
20 Participants
|
16 Participants
|
16 Participants
|
21 Participants
|
23 Participants
|
20 Participants
|
17 Participants
|
16 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Moderate
|
6 Participants
|
26 Participants
|
23 Participants
|
4 Participants
|
18 Participants
|
21 Participants
|
27 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · None
|
2 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Mild
|
21 Participants
|
16 Participants
|
22 Participants
|
22 Participants
|
21 Participants
|
16 Participants
|
18 Participants
|
16 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Moderate
|
7 Participants
|
28 Participants
|
23 Participants
|
4 Participants
|
20 Participants
|
30 Participants
|
28 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Life Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 1: Less than 5 cm diameter
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · None
|
26 Participants
|
35 Participants
|
38 Participants
|
23 Participants
|
34 Participants
|
36 Participants
|
31 Participants
|
21 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Not gradable
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 1: Less than 5 cm diameter
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 1: Between 6.25 to 25 cm sq area
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 2: Between 5 to 10 cm diameter
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 2: Between 25 to 100 cm sq area
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 3: Greater or equal to 10 cm
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 3: Greater or equal to 100 cm sq
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 3: complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema · Grade 4: complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · None
|
28 Participants
|
35 Participants
|
37 Participants
|
23 Participants
|
33 Participants
|
38 Participants
|
36 Participants
|
24 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Not gradable
|
1 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 1: Between 6.25 to 25 cm sq area
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 2: Between 5 to 10 cm diameter
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 2: Between 25 to 100 cm sq area
|
1 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 3: Greater or equal to 10 cm
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 3: Greater or equal to 100 cm sq
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 3: complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration · Grade 4: complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
25 Participants
|
31 Participants
|
34 Participants
|
22 Participants
|
31 Participants
|
35 Participants
|
30 Participants
|
21 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Not gradable
|
3 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 1: Less than 5 cm diameter
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 1: Between 6.25 to 25 cm sq area
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 2: Between 5 to 10 cm diameter
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 2: Between 25 to 100 cm sq area
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 3: Greater or equal to 10 cm
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 3: Greater or equal to 100 cm sq
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 3: complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Grade 4: complications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
10 Participants
|
19 Participants
|
19 Participants
|
13 Participants
|
16 Participants
|
12 Participants
|
15 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
7 Participants
|
17 Participants
|
19 Participants
|
7 Participants
|
19 Participants
|
31 Participants
|
22 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
6 Participants
|
9 Participants
|
0 Participants
|
11 Participants
|
19 Participants
|
17 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
25 Participants
|
38 Participants
|
33 Participants
|
26 Participants
|
29 Participants
|
26 Participants
|
24 Participants
|
20 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
5 Participants
|
9 Participants
|
12 Participants
|
4 Participants
|
15 Participants
|
10 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
12 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
12 Participants
|
13 Participants
|
8 Participants
|
8 Participants
|
11 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
29 Participants
|
41 Participants
|
38 Participants
|
26 Participants
|
37 Participants
|
39 Participants
|
36 Participants
|
22 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
1 Participants
|
4 Participants
|
9 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
9 Participants
|
16 Participants
|
15 Participants
|
11 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
4 Participants
|
10 Participants
|
15 Participants
|
3 Participants
|
14 Participants
|
22 Participants
|
20 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
14 Participants
|
20 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
11 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
11 Participants
|
21 Participants
|
15 Participants
|
10 Participants
|
18 Participants
|
14 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
4 Participants
|
8 Participants
|
14 Participants
|
1 Participants
|
13 Participants
|
21 Participants
|
23 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
17 Participants
|
24 Participants
|
20 Participants
|
16 Participants
|
23 Participants
|
15 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
20 Participants
|
21 Participants
|
15 Participants
|
14 Participants
|
18 Participants
|
14 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
7 Participants
|
21 Participants
|
21 Participants
|
11 Participants
|
18 Participants
|
14 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
3 Participants
|
7 Participants
|
14 Participants
|
4 Participants
|
11 Participants
|
21 Participants
|
20 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
21 Participants
|
37 Participants
|
34 Participants
|
22 Participants
|
38 Participants
|
30 Participants
|
30 Participants
|
20 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
7 Participants
|
12 Participants
|
11 Participants
|
6 Participants
|
8 Participants
|
13 Participants
|
10 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
29 Participants
|
46 Participants
|
47 Participants
|
29 Participants
|
45 Participants
|
45 Participants
|
42 Participants
|
20 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
27 Participants
|
34 Participants
|
32 Participants
|
25 Participants
|
25 Participants
|
22 Participants
|
23 Participants
|
21 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
3 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
12 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Related
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Not Related
|
21 Participants
|
32 Participants
|
33 Participants
|
15 Participants
|
35 Participants
|
27 Participants
|
25 Participants
|
12 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
No AE reported
|
6 Participants
|
16 Participants
|
16 Participants
|
10 Participants
|
11 Participants
|
19 Participants
|
23 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Mild
|
11 Participants
|
13 Participants
|
10 Participants
|
6 Participants
|
19 Participants
|
8 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Moderate
|
12 Participants
|
19 Participants
|
22 Participants
|
10 Participants
|
16 Participants
|
22 Participants
|
16 Participants
|
10 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Severe
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
No AE reported
|
6 Participants
|
16 Participants
|
16 Participants
|
10 Participants
|
11 Participants
|
19 Participants
|
23 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18There were no adverse events of special interest reported by any participant.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12There were no new chronic conditions (requiring medical intervention for ≥ 30 days) reported by any participant.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 6.5From the study product discontinuation form, study product administration reasons are tabulated by treatment arm.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Clinical event
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity symptom
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Other reason
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
No Discontinuation
|
26 Participants
|
48 Participants
|
48 Participants
|
28 Participants
|
47 Participants
|
43 Participants
|
43 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
ALT (SGPT) (U/L)-Day 42
|
14 U/L
Interval 12.0 to 17.0
|
14 U/L
Interval 11.0 to 19.0
|
14 U/L
Interval 11.0 to 22.0
|
13 U/L
Interval 10.0 to 17.0
|
16 U/L
Interval 12.0 to 25.0
|
16 U/L
Interval 10.0 to 20.0
|
15 U/L
Interval 11.0 to 20.0
|
14 U/L
Interval 10.0 to 19.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
AST (U/L)-Day 14
|
18 U/L
Interval 16.5 to 21.0
|
18 U/L
Interval 15.0 to 22.0
|
19 U/L
Interval 16.0 to 25.0
|
18 U/L
Interval 15.0 to 21.0
|
19.5 U/L
Interval 16.0 to 23.0
|
19.5 U/L
Interval 15.0 to 25.0
|
19 U/L
Interval 15.0 to 22.0
|
19 U/L
Interval 17.0 to 21.5
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
AST (U/L)-Day 42
|
19.5 U/L
Interval 17.0 to 21.0
|
19 U/L
Interval 16.0 to 22.0
|
18 U/L
Interval 15.0 to 22.0
|
16.5 U/L
Interval 14.0 to 20.5
|
19 U/L
Interval 16.0 to 25.0
|
19 U/L
Interval 15.0 to 23.0
|
19 U/L
Interval 18.0 to 22.0
|
19 U/L
Interval 15.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
Alkaline Phosphatase (U/L)-Day 14
|
60.5 U/L
Interval 45.5 to 68.5
|
67 U/L
Interval 56.0 to 84.0
|
62.5 U/L
Interval 53.0 to 89.0
|
65.5 U/L
Interval 49.0 to 76.0
|
64 U/L
Interval 53.0 to 80.0
|
68 U/L
Interval 55.0 to 81.5
|
63 U/L
Interval 51.0 to 77.5
|
65.5 U/L
Interval 50.5 to 75.5
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
ALT (SGPT) (U/L)-Screening
|
15 U/L
Interval 12.0 to 18.0
|
14.5 U/L
Interval 12.0 to 20.0
|
15 U/L
Interval 11.0 to 18.0
|
13.5 U/L
Interval 11.0 to 20.0
|
16.5 U/L
Interval 13.0 to 25.0
|
16 U/L
Interval 11.0 to 23.0
|
15 U/L
Interval 12.0 to 21.0
|
17 U/L
Interval 12.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
ALT (SGPT) (U/L)-Day 14
|
14 U/L
Interval 12.5 to 16.5
|
16 U/L
Interval 11.0 to 19.0
|
16 U/L
Interval 12.0 to 21.0
|
13 U/L
Interval 10.0 to 19.0
|
17.5 U/L
Interval 13.0 to 24.0
|
16 U/L
Interval 11.0 to 23.5
|
15.5 U/L
Interval 10.0 to 19.5
|
16 U/L
Interval 11.0 to 20.5
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
ALT (SGPT) (U/L)-Day 98
|
15 U/L
Interval 12.0 to 17.5
|
15 U/L
Interval 12.0 to 20.0
|
14.5 U/L
Interval 10.0 to 20.0
|
14 U/L
Interval 10.0 to 20.0
|
18 U/L
Interval 13.0 to 26.0
|
17 U/L
Interval 12.0 to 23.0
|
15 U/L
Interval 12.0 to 18.0
|
16 U/L
Interval 12.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
ALT (SGPT) (U/L)-Day 182
|
15 U/L
Interval 13.0 to 18.0
|
17 U/L
Interval 13.0 to 22.0
|
14 U/L
Interval 11.0 to 21.0
|
16 U/L
Interval 11.0 to 20.0
|
16 U/L
Interval 13.0 to 23.5
|
19.5 U/L
Interval 10.0 to 27.0
|
16 U/L
Interval 11.0 to 22.0
|
20 U/L
Interval 11.0 to 27.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
AST (U/L)-Screening
|
20 U/L
Interval 17.0 to 22.0
|
18.5 U/L
Interval 16.0 to 23.0
|
19 U/L
Interval 16.0 to 23.0
|
19 U/L
Interval 16.0 to 24.0
|
20 U/L
Interval 17.0 to 22.0
|
19 U/L
Interval 16.0 to 24.0
|
19.5 U/L
Interval 16.0 to 23.0
|
20 U/L
Interval 16.5 to 22.5
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
AST (U/L)-Day 98
|
17.5 U/L
Interval 15.5 to 21.0
|
18 U/L
Interval 16.0 to 22.0
|
18.5 U/L
Interval 15.0 to 22.0
|
18 U/L
Interval 15.0 to 22.0
|
20 U/L
Interval 16.0 to 23.0
|
20 U/L
Interval 16.0 to 26.0
|
18 U/L
Interval 15.5 to 22.5
|
20 U/L
Interval 18.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
AST (U/L)-Day 182
|
19 U/L
Interval 15.5 to 21.5
|
20 U/L
Interval 16.0 to 24.0
|
19 U/L
Interval 16.0 to 23.0
|
18.5 U/L
Interval 16.0 to 26.0
|
19.5 U/L
Interval 17.0 to 23.0
|
21 U/L
Interval 17.0 to 27.0
|
19 U/L
Interval 16.0 to 23.0
|
23 U/L
Interval 18.0 to 28.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
Alkaline Phosphatase (U/L)-Screening
|
60.5 U/L
Interval 47.0 to 71.0
|
72.5 U/L
Interval 60.0 to 89.0
|
70.5 U/L
Interval 59.0 to 88.0
|
70 U/L
Interval 54.0 to 78.0
|
69.5 U/L
Interval 54.0 to 80.0
|
70 U/L
Interval 55.0 to 83.0
|
66 U/L
Interval 58.0 to 85.0
|
59.5 U/L
Interval 55.0 to 80.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
Alkaline Phosphatase (U/L)-Day 42
|
60 U/L
Interval 48.0 to 68.0
|
67 U/L
Interval 57.0 to 78.0
|
67 U/L
Interval 55.0 to 84.0
|
64 U/L
Interval 51.5 to 77.5
|
62 U/L
Interval 54.0 to 81.0
|
68 U/L
Interval 56.0 to 79.0
|
65 U/L
Interval 51.0 to 76.0
|
67 U/L
Interval 57.0 to 80.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
Alkaline Phosphatase (U/L)-Day 98
|
60 U/L
Interval 47.0 to 69.0
|
64 U/L
Interval 60.0 to 78.0
|
65 U/L
Interval 56.0 to 84.0
|
63 U/L
Interval 52.0 to 75.0
|
62 U/L
Interval 52.0 to 78.0
|
68 U/L
Interval 53.0 to 77.0
|
62 U/L
Interval 53.0 to 75.0
|
66.5 U/L
Interval 48.0 to 82.0
|
|
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.
Alkaline Phosphatase (U/L)-Day 182
|
62.5 U/L
Interval 50.0 to 74.5
|
70 U/L
Interval 61.0 to 77.0
|
70 U/L
Interval 57.0 to 88.0
|
69 U/L
Interval 53.0 to 85.0
|
64.5 U/L
Interval 52.0 to 78.0
|
69.5 U/L
Interval 60.0 to 81.0
|
65 U/L
Interval 57.0 to 79.0
|
68 U/L
Interval 54.0 to 85.0
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine.
Creatinine (mg/dL)-Screening
|
0.795 mg/dL
Interval 0.7 to 0.92
|
0.8 mg/dL
Interval 0.7 to 0.91
|
0.8 mg/dL
Interval 0.7 to 0.89
|
0.79 mg/dL
Interval 0.7 to 0.91
|
0.77 mg/dL
Interval 0.67 to 0.87
|
0.715 mg/dL
Interval 0.62 to 0.87
|
0.8 mg/dL
Interval 0.7 to 0.9
|
0.8 mg/dL
Interval 0.7 to 0.9
|
|
Chemistry and Hematology Laboratory Measures - Creatinine.
Creatinine (mg/dL)-Day 14
|
0.785 mg/dL
Interval 0.685 to 0.97
|
0.84 mg/dL
Interval 0.65 to 0.95
|
0.8 mg/dL
Interval 0.7 to 0.87
|
0.88 mg/dL
Interval 0.77 to 0.95
|
0.78 mg/dL
Interval 0.65 to 0.9
|
0.79 mg/dL
Interval 0.7 to 0.88
|
0.8 mg/dL
Interval 0.7 to 0.915
|
0.805 mg/dL
Interval 0.7 to 0.895
|
|
Chemistry and Hematology Laboratory Measures - Creatinine.
Creatinine (mg/dL)-Day 42
|
0.83 mg/dL
Interval 0.71 to 0.92
|
0.83 mg/dL
Interval 0.7 to 0.95
|
0.805 mg/dL
Interval 0.7 to 0.9
|
0.81 mg/dL
Interval 0.77 to 0.9
|
0.8 mg/dL
Interval 0.7 to 0.89
|
0.79 mg/dL
Interval 0.63 to 0.9
|
0.8 mg/dL
Interval 0.7 to 0.93
|
0.84 mg/dL
Interval 0.72 to 0.94
|
|
Chemistry and Hematology Laboratory Measures - Creatinine.
Creatinine (mg/dL)-Day 98
|
0.815 mg/dL
Interval 0.72 to 0.905
|
0.8 mg/dL
Interval 0.695 to 0.945
|
0.8 mg/dL
Interval 0.7 to 0.94
|
0.81 mg/dL
Interval 0.72 to 0.91
|
0.78 mg/dL
Interval 0.7 to 0.9
|
0.79 mg/dL
Interval 0.7 to 0.81
|
0.83 mg/dL
Interval 0.7 to 0.95
|
0.9 mg/dL
Interval 0.75 to 0.94
|
|
Chemistry and Hematology Laboratory Measures - Creatinine.
Creatinine (mg/dL)-Day 182
|
0.81 mg/dL
Interval 0.7 to 0.93
|
0.855 mg/dL
Interval 0.72 to 0.98
|
0.8 mg/dL
Interval 0.7 to 0.93
|
0.84 mg/dL
Interval 0.76 to 0.98
|
0.8 mg/dL
Interval 0.7 to 0.9
|
0.785 mg/dL
Interval 0.7 to 0.9
|
0.84 mg/dL
Interval 0.7 to 1.0
|
0.87 mg/dL
Interval 0.8 to 0.93
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin.
Hemoglobin (g/dL)-Screening
|
14.15 g/dL
Interval 12.6 to 14.9
|
14.3 g/dL
Interval 13.3 to 15.5
|
14.2 g/dL
Interval 13.0 to 15.4
|
14.2 g/dL
Interval 13.5 to 15.5
|
14.2 g/dL
Interval 13.5 to 15.3
|
14.5 g/dL
Interval 12.9 to 15.3
|
13.85 g/dL
Interval 13.3 to 15.3
|
14.6 g/dL
Interval 12.95 to 15.15
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin.
Hemoglobin (g/dL)-Day 14
|
13.6 g/dL
Interval 12.6 to 14.4
|
13.8 g/dL
Interval 13.2 to 14.8
|
13.6 g/dL
Interval 12.4 to 14.7
|
13.55 g/dL
Interval 12.6 to 15.0
|
13.9 g/dL
Interval 12.7 to 14.9
|
13.7 g/dL
Interval 12.1 to 14.65
|
13.4 g/dL
Interval 12.85 to 14.5
|
14.05 g/dL
Interval 12.5 to 14.5
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin.
Hemoglobin (g/dL)-Day 42
|
13.6 g/dL
Interval 13.0 to 15.1
|
13.8 g/dL
Interval 12.9 to 14.8
|
13.8 g/dL
Interval 12.7 to 14.8
|
13.75 g/dL
Interval 12.75 to 14.7
|
13.9 g/dL
Interval 13.3 to 15.2
|
14 g/dL
Interval 12.5 to 15.0
|
13.9 g/dL
Interval 13.0 to 14.5
|
14 g/dL
Interval 13.1 to 14.7
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin.
Hemoglobin (g/dL)-Day 98
|
13.5 g/dL
Interval 12.8 to 15.2
|
13.95 g/dL
Interval 12.75 to 15.25
|
13.9 g/dL
Interval 13.1 to 15.0
|
13.7 g/dL
Interval 12.9 to 15.1
|
14.1 g/dL
Interval 13.1 to 15.4
|
14.05 g/dL
Interval 12.8 to 15.0
|
14 g/dL
Interval 13.2 to 15.0
|
14.35 g/dL
Interval 12.6 to 14.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin.
Hemoglobin (g/dL)-Day 182
|
13.75 g/dL
Interval 13.2 to 15.05
|
14 g/dL
Interval 13.4 to 15.3
|
14.1 g/dL
Interval 13.2 to 15.4
|
14 g/dL
Interval 12.9 to 15.2
|
14.03 g/dL
Interval 12.6 to 15.0
|
14.05 g/dL
Interval 13.0 to 15.0
|
14.05 g/dL
Interval 13.5 to 15.0
|
14.1 g/dL
Interval 13.4 to 15.2
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Neutrophils (cells/cubic mm)-Day 42
|
3149 cells/cubic mm
Interval 2840.0 to 4349.0
|
2795 cells/cubic mm
Interval 2255.5 to 4220.0
|
3300 cells/cubic mm
Interval 2448.0 to 4250.0
|
3467.5 cells/cubic mm
Interval 2790.0 to 4144.0
|
3440 cells/cubic mm
Interval 2773.0 to 4370.0
|
3580 cells/cubic mm
Interval 2740.0 to 4370.0
|
3630 cells/cubic mm
Interval 2805.0 to 4678.0
|
3532 cells/cubic mm
Interval 2729.0 to 4910.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Neutrophils (cells/cubic mm)-Day 98
|
2980 cells/cubic mm
Interval 2310.0 to 4002.0
|
2969 cells/cubic mm
Interval 2272.0 to 3763.5
|
3602.5 cells/cubic mm
Interval 2622.0 to 4310.0
|
3805 cells/cubic mm
Interval 3103.0 to 4540.0
|
3519 cells/cubic mm
Interval 2904.0 to 4193.0
|
3331.5 cells/cubic mm
Interval 2730.0 to 4482.0
|
3345 cells/cubic mm
Interval 2542.0 to 3928.0
|
3433 cells/cubic mm
Interval 2656.0 to 4110.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Lymphocytes (cells/cubic mm)-Day 98
|
1859 cells/cubic mm
Interval 1570.0 to 2111.0
|
1920.5 cells/cubic mm
Interval 1599.5 to 2135.5
|
2010 cells/cubic mm
Interval 1722.0 to 2332.0
|
2035 cells/cubic mm
Interval 1651.0 to 2550.0
|
2003 cells/cubic mm
Interval 1660.0 to 2330.0
|
1907.5 cells/cubic mm
Interval 1653.0 to 2180.0
|
1863 cells/cubic mm
Interval 1640.0 to 2230.0
|
2198 cells/cubic mm
Interval 1922.0 to 2613.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Neutrophils (cells/cubic mm)-Screening
|
4060.5 cells/cubic mm
Interval 2740.0 to 5069.0
|
3540 cells/cubic mm
Interval 2870.0 to 4352.0
|
3108.5 cells/cubic mm
Interval 2670.0 to 4498.0
|
3919 cells/cubic mm
Interval 3280.0 to 4627.0
|
3616 cells/cubic mm
Interval 2725.0 to 4718.0
|
3505 cells/cubic mm
Interval 2719.0 to 4269.0
|
3389 cells/cubic mm
Interval 2684.0 to 4397.0
|
3861 cells/cubic mm
Interval 2953.5 to 4597.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Neutrophils (cells/cubic mm)-Day 14
|
3156.5 cells/cubic mm
Interval 2499.0 to 4400.5
|
3230 cells/cubic mm
Interval 2437.0 to 3830.0
|
3404 cells/cubic mm
Interval 2353.0 to 4158.0
|
3108 cells/cubic mm
Interval 2717.0 to 4623.0
|
3910 cells/cubic mm
Interval 2614.0 to 4854.0
|
3874 cells/cubic mm
Interval 2840.5 to 5127.5
|
3420 cells/cubic mm
Interval 2535.0 to 4515.5
|
3366.5 cells/cubic mm
Interval 2682.0 to 5314.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Neutrophils (cells/cubic mm)-Day 182
|
3061 cells/cubic mm
Interval 2815.5 to 4376.5
|
3259 cells/cubic mm
Interval 2562.0 to 4132.0
|
3311 cells/cubic mm
Interval 2636.0 to 4534.0
|
3508.5 cells/cubic mm
Interval 2754.0 to 4863.0
|
3616 cells/cubic mm
Interval 2840.0 to 4863.0
|
3395 cells/cubic mm
Interval 2758.0 to 4190.0
|
3794.5 cells/cubic mm
Interval 2897.0 to 5210.0
|
3370 cells/cubic mm
Interval 2738.0 to 3926.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Lymphocytes (cells/cubic mm)-Screening
|
2033 cells/cubic mm
Interval 1660.0 to 2590.0
|
1906 cells/cubic mm
Interval 1670.0 to 2470.0
|
2044.5 cells/cubic mm
Interval 1730.0 to 2405.0
|
1993.5 cells/cubic mm
Interval 1610.0 to 2310.0
|
2054.5 cells/cubic mm
Interval 1550.0 to 2412.0
|
2002.5 cells/cubic mm
Interval 1740.0 to 2384.0
|
1942 cells/cubic mm
Interval 1570.0 to 2270.0
|
2150 cells/cubic mm
Interval 1940.5 to 2796.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Lymphocytes (cells/cubic mm)-Day 14
|
1963.5 cells/cubic mm
Interval 1578.0 to 2269.5
|
1953 cells/cubic mm
Interval 1587.0 to 2469.0
|
1936 cells/cubic mm
Interval 1593.0 to 2283.0
|
1965 cells/cubic mm
Interval 1699.0 to 2440.0
|
1857 cells/cubic mm
Interval 1600.0 to 2356.0
|
2014.5 cells/cubic mm
Interval 1621.0 to 2303.0
|
1746.5 cells/cubic mm
Interval 1540.0 to 2138.0
|
2030.5 cells/cubic mm
Interval 1891.0 to 2296.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Lymphocytes (cells/cubic mm)-Day 42
|
1881.5 cells/cubic mm
Interval 1611.0 to 2150.0
|
1794 cells/cubic mm
Interval 1430.0 to 2488.0
|
1972 cells/cubic mm
Interval 1681.0 to 2320.0
|
1944 cells/cubic mm
Interval 1720.0 to 2465.0
|
2060 cells/cubic mm
Interval 1784.0 to 2640.0
|
1990 cells/cubic mm
Interval 1752.0 to 2267.0
|
1910 cells/cubic mm
Interval 1556.0 to 2400.0
|
2008 cells/cubic mm
Interval 1650.0 to 2450.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.
Lymphocytes (cells/cubic mm)-Day 182
|
1868 cells/cubic mm
Interval 1385.0 to 2175.0
|
1887 cells/cubic mm
Interval 1590.0 to 2309.0
|
1848.5 cells/cubic mm
Interval 1550.0 to 2264.0
|
2090.5 cells/cubic mm
Interval 1566.0 to 2400.0
|
1990 cells/cubic mm
Interval 1810.0 to 2570.0
|
2066.5 cells/cubic mm
Interval 1683.0 to 2310.0
|
1795 cells/cubic mm
Interval 1522.0 to 2291.0
|
1962 cells/cubic mm
Interval 1806.5 to 2569.0
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
Platelets (x1000/cubic mm)-Day 14
|
223.5 x1000/cubic mm
Interval 201.5 to 281.5
|
236 x1000/cubic mm
Interval 215.0 to 299.0
|
264.5 x1000/cubic mm
Interval 218.4 to 311.0
|
255.15 x1000/cubic mm
Interval 233.0 to 291.0
|
285 x1000/cubic mm
Interval 245.0 to 318.0
|
279.5 x1000/cubic mm
Interval 249.0 to 318.5
|
284 x1000/cubic mm
Interval 249.0 to 310.5
|
257.5 x1000/cubic mm
Interval 230.0 to 289.5
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
WBC (x1000/cubic mm)-Screening
|
6.53 x1000/cubic mm
Interval 5.57 to 8.27
|
6.45 x1000/cubic mm
Interval 5.3 to 7.32
|
5.94 x1000/cubic mm
Interval 4.92 to 7.87
|
6.665 x1000/cubic mm
Interval 5.72 to 7.2
|
6.35 x1000/cubic mm
Interval 5.17 to 7.6
|
5.94 x1000/cubic mm
Interval 5.17 to 7.66
|
6.17 x1000/cubic mm
Interval 5.3 to 6.81
|
7.135 x1000/cubic mm
Interval 5.705 to 8.08
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
WBC (x1000/cubic mm)-Day 14
|
5.705 x1000/cubic mm
Interval 5.06 to 6.905
|
6.04 x1000/cubic mm
Interval 4.68 to 7.1
|
5.795 x1000/cubic mm
Interval 4.64 to 6.86
|
6.155 x1000/cubic mm
Interval 5.05 to 6.9
|
6.41 x1000/cubic mm
Interval 4.96 to 7.85
|
6.25 x1000/cubic mm
Interval 5.25 to 8.225
|
6 x1000/cubic mm
Interval 5.11 to 7.17
|
6.36 x1000/cubic mm
Interval 5.37 to 7.96
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
WBC (x1000/cubic mm)-Day 42
|
5.815 x1000/cubic mm
Interval 5.0 to 7.24
|
5.55 x1000/cubic mm
Interval 4.6 to 7.1
|
6 x1000/cubic mm
Interval 4.68 to 7.2
|
6.04 x1000/cubic mm
Interval 5.265 to 7.4
|
6.25 x1000/cubic mm
Interval 5.3 to 7.63
|
6.4 x1000/cubic mm
Interval 5.34 to 7.26
|
6.09 x1000/cubic mm
Interval 5.38 to 7.4
|
6.9 x1000/cubic mm
Interval 5.2 to 8.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
WBC (x1000/cubic mm)-Day 98
|
5.92 x1000/cubic mm
Interval 4.56 to 6.4
|
5.69 x1000/cubic mm
Interval 4.635 to 6.705
|
5.985 x1000/cubic mm
Interval 5.02 to 7.34
|
6.68 x1000/cubic mm
Interval 5.91 to 7.48
|
6.22 x1000/cubic mm
Interval 5.02 to 7.3
|
6.075 x1000/cubic mm
Interval 5.28 to 7.24
|
5.8 x1000/cubic mm
Interval 5.2 to 6.9
|
6.41 x1000/cubic mm
Interval 5.4 to 6.92
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
WBC (x1000/cubic mm)-Day 182
|
5.6 x1000/cubic mm
Interval 4.875 to 7.345
|
6.29 x1000/cubic mm
Interval 5.0 to 7.4
|
5.515 x1000/cubic mm
Interval 5.1 to 7.36
|
6.46 x1000/cubic mm
Interval 5.31 to 7.6
|
6.39 x1000/cubic mm
Interval 5.44 to 7.6
|
5.9 x1000/cubic mm
Interval 5.31 to 7.35
|
6.585 x1000/cubic mm
Interval 5.5 to 7.54
|
5.835 x1000/cubic mm
Interval 5.31 to 7.42
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
Platelets (x1000/cubic mm)-Screening
|
232.5 x1000/cubic mm
Interval 199.0 to 311.0
|
243 x1000/cubic mm
Interval 216.0 to 296.0
|
269.5 x1000/cubic mm
Interval 226.0 to 304.0
|
258 x1000/cubic mm
Interval 228.0 to 291.0
|
275 x1000/cubic mm
Interval 225.0 to 314.0
|
280 x1000/cubic mm
Interval 240.0 to 303.0
|
264.5 x1000/cubic mm
Interval 238.0 to 288.0
|
252.5 x1000/cubic mm
Interval 226.5 to 303.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
Platelets (x1000/cubic mm)-Day 42
|
222.5 x1000/cubic mm
Interval 206.6 to 282.0
|
241 x1000/cubic mm
Interval 210.0 to 285.0
|
264 x1000/cubic mm
Interval 204.0 to 303.0
|
258.95 x1000/cubic mm
Interval 242.0 to 310.85
|
292 x1000/cubic mm
Interval 250.0 to 331.0
|
288 x1000/cubic mm
Interval 247.0 to 320.0
|
286 x1000/cubic mm
Interval 251.0 to 334.0
|
248 x1000/cubic mm
Interval 227.5 to 299.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
Platelets (x1000/cubic mm)-Day 98
|
241 x1000/cubic mm
Interval 200.9 to 287.0
|
250.5 x1000/cubic mm
Interval 213.2 to 318.0
|
271 x1000/cubic mm
Interval 220.0 to 334.0
|
254 x1000/cubic mm
Interval 224.0 to 289.0
|
258 x1000/cubic mm
Interval 228.0 to 291.0
|
259 x1000/cubic mm
Interval 230.0 to 290.0
|
260 x1000/cubic mm
Interval 232.0 to 292.0
|
262.75 x1000/cubic mm
Interval 218.0 to 284.8
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC.
Platelets (x1000/cubic mm)-Day 182
|
238.5 x1000/cubic mm
Interval 198.5 to 276.0
|
265.9 x1000/cubic mm
Interval 224.0 to 309.0
|
269.5 x1000/cubic mm
Interval 230.0 to 324.0
|
256.2 x1000/cubic mm
Interval 232.0 to 288.0
|
284 x1000/cubic mm
Interval 240.0 to 327.0
|
276 x1000/cubic mm
Interval 244.0 to 306.0
|
279 x1000/cubic mm
Interval 246.0 to 315.0
|
257.5 x1000/cubic mm
Interval 237.5 to 293.0
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6The numbers (percentages) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment group for each post vaccination timepoint.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.
Lymphocytes (cells/cubic mm)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.
Platelets (x1000/cubic mm)-Day 14
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.
AST (U/L)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.
Creatinine (mg/dL)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.
Creatinine (mg/dL)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.
Creatinine (mg/dL)-Day 98
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.
Creatinine (mg/dL)-Day 182
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens. Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.
00MSA 4076 gp140
|
19 Participants
|
41 Participants
|
42 Participants
|
24 Participants
|
39 Participants
|
33 Participants
|
38 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.
1086C_D7gp120.avi/293F
|
19 Participants
|
44 Participants
|
44 Participants
|
24 Participants
|
39 Participants
|
35 Participants
|
39 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.
96ZM651.gp140C.avi
|
19 Participants
|
42 Participants
|
42 Participants
|
24 Participants
|
39 Participants
|
34 Participants
|
38 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.
A1.con.env03 140 CF
|
19 Participants
|
41 Participants
|
42 Participants
|
24 Participants
|
39 Participants
|
34 Participants
|
37 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.
Con 6 gp120/B
|
19 Participants
|
41 Participants
|
42 Participants
|
24 Participants
|
36 Participants
|
33 Participants
|
36 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.
Con S gp140 CFI
|
20 Participants
|
42 Participants
|
42 Participants
|
24 Participants
|
39 Participants
|
35 Participants
|
39 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens.Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.
00MSA 4076 gp140
|
22000 relative fluorescence units
Interval 11213.5 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 15544.625 to 22000.0
|
22000 relative fluorescence units
Interval 14452.5 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 21484.5 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.
1086C_D7gp120.avi/293F
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 5.0
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.
96ZM651.gp140C.avi
|
21251 relative fluorescence units
Interval 11922.5 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 21760.75 to 22000.0
|
22000 relative fluorescence units
Interval 17409.5 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.
A1.con.env03 140 CF
|
22000 relative fluorescence units
Interval 15131.25 to 22000.0
|
22000 relative fluorescence units
Interval 20624.625 to 22000.0
|
22000 relative fluorescence units
Interval 15995.5 to 22000.0
|
22000 relative fluorescence units
Interval 13013.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 19209.125 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.
Con 6 gp120/B
|
22000 relative fluorescence units
Interval 10550.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 18086.25 to 22000.0
|
22000 relative fluorescence units
Interval 16341.75 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 20235.75 to 22000.0
|
9.75 relative fluorescence units
Interval 1.0 to 62.0
|
|
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.
Con S gp140 CFI
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 4.25
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.
gp70-TV1.GSKvacV1V2/293F
|
16 Participants
|
35 Participants
|
24 Participants
|
23 Participants
|
35 Participants
|
31 Participants
|
30 Participants
|
0 Participants
|
|
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.
TV1c8_D11gp120.avi/293F
|
19 Participants
|
42 Participants
|
43 Participants
|
24 Participants
|
39 Participants
|
36 Participants
|
40 Participants
|
0 Participants
|
|
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.
gp70_B.CaseA_V1_V2
|
16 Participants
|
31 Participants
|
20 Participants
|
22 Participants
|
33 Participants
|
30 Participants
|
28 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.
TV1c8_D11gp120.avi/293F
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
1 relative fluorescence units
Interval 1.0 to 26.75
|
|
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.
gp70-TV1.GSKvacV1V2/293F
|
521.5 relative fluorescence units
Interval 113.75 to 6977.75
|
1656 relative fluorescence units
Interval 136.0 to 11641.600001
|
330 relative fluorescence units
Interval 1.0 to 1337.25
|
4948.75 relative fluorescence units
Interval 1574.25 to 11707.75
|
16511.5 relative fluorescence units
Interval 2093.0 to 22000.0
|
10392.25 relative fluorescence units
Interval 1706.5 to 22000.0
|
2409 relative fluorescence units
Interval 317.125 to 16400.5
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
|
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.
gp70_B.CaseA_V1_V2
|
744.5 relative fluorescence units
Interval 148.75 to 7460.75
|
1110.625 relative fluorescence units
Interval 86.125 to 7316.5
|
184.5 relative fluorescence units
Interval 1.0 to 1269.75
|
1881 relative fluorescence units
Interval 589.0 to 6311.0
|
5559 relative fluorescence units
Interval 1255.0 to 18096.5
|
5231.875 relative fluorescence units
Interval 1003.5 to 10415.25
|
1329.625 relative fluorescence units
Interval 179.625 to 8718.0
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: Data were not collected
The neutralizing antibody assay was not run. Therefore this dataset doesn't exist
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
ANY HIV
|
20 Participants
|
47 Participants
|
43 Participants
|
21 Participants
|
42 Participants
|
40 Participants
|
40 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
ANY POL
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
Env-2-ZM96
|
12 Participants
|
25 Participants
|
28 Participants
|
5 Participants
|
18 Participants
|
21 Participants
|
16 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
Gag-ZM96
|
9 Participants
|
14 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
Nef-CN54
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
ANY ENV
|
20 Participants
|
47 Participants
|
42 Participants
|
20 Participants
|
42 Participants
|
40 Participants
|
40 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
Env-1-ZM96
|
16 Participants
|
41 Participants
|
40 Participants
|
12 Participants
|
32 Participants
|
34 Participants
|
26 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
Pol-1-CN54
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
Pol-2-CN54
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
TV1 gp120
|
17 Participants
|
47 Participants
|
42 Participants
|
17 Participants
|
41 Participants
|
39 Participants
|
38 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.
1086 gp120
|
17 Participants
|
47 Participants
|
42 Participants
|
17 Participants
|
38 Participants
|
40 Participants
|
39 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
ANY HIV
|
0.237 percent T-cells
Interval 0.084 to 0.437
|
0.388 percent T-cells
Interval 0.245 to 0.521
|
0.492 percent T-cells
Interval 0.334 to 0.827
|
0.156 percent T-cells
Interval 0.06 to 0.253
|
0.364 percent T-cells
Interval 0.187 to 0.495
|
0.48 percent T-cells
Interval 0.334 to 0.681
|
0.52 percent T-cells
Interval 0.209 to 0.69
|
0.016 percent T-cells
Interval -0.013 to 0.036
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
ANY ENV
|
0.189 percent T-cells
Interval 0.076 to 0.332
|
0.37 percent T-cells
Interval 0.228 to 0.485
|
0.451 percent T-cells
Interval 0.334 to 0.829
|
0.124 percent T-cells
Interval 0.054 to 0.227
|
0.328 percent T-cells
Interval 0.167 to 0.484
|
0.456 percent T-cells
Interval 0.357 to 0.65
|
0.504 percent T-cells
Interval 0.202 to 0.741
|
0.015 percent T-cells
Interval 0.006 to 0.02
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
ANY POL
|
0.003 percent T-cells
Interval -0.009 to 0.01
|
-0.001 percent T-cells
Interval -0.011 to 0.007
|
0 percent T-cells
Interval -0.016 to 0.01
|
0.003 percent T-cells
Interval -0.008 to 0.01
|
-0.001 percent T-cells
Interval -0.009 to 0.011
|
-0.002 percent T-cells
Interval -0.017 to 0.01
|
-0.002 percent T-cells
Interval -0.01 to 0.005
|
0.001 percent T-cells
Interval -0.009 to 0.01
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
Env-1-ZM96
|
0.076 percent T-cells
Interval 0.038 to 0.21
|
0.196 percent T-cells
Interval 0.117 to 0.305
|
0.272 percent T-cells
Interval 0.14 to 0.445
|
0.038 percent T-cells
Interval 0.021 to 0.072
|
0.12 percent T-cells
Interval 0.054 to 0.155
|
0.186 percent T-cells
Interval 0.092 to 0.261
|
0.092 percent T-cells
Interval 0.033 to 0.232
|
0.008 percent T-cells
Interval -0.001 to 0.015
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
Env-2-ZM96
|
0.047 percent T-cells
Interval 0.016 to 0.104
|
0.052 percent T-cells
Interval 0.031 to 0.088
|
0.085 percent T-cells
Interval 0.038 to 0.161
|
0.02 percent T-cells
Interval 0.009 to 0.025
|
0.04 percent T-cells
Interval 0.015 to 0.108
|
0.054 percent T-cells
Interval 0.019 to 0.095
|
0.045 percent T-cells
Interval 0.015 to 0.097
|
0 percent T-cells
Interval -0.004 to 0.008
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
Gag-ZM96
|
0.039 percent T-cells
Interval 0.013 to 0.066
|
0.027 percent T-cells
Interval 0.014 to 0.05
|
0.03 percent T-cells
Interval 0.013 to 0.054
|
0.016 percent T-cells
Interval 0.011 to 0.022
|
0.011 percent T-cells
Interval 0.001 to 0.025
|
0.013 percent T-cells
Interval 0.006 to 0.045
|
-0.002 percent T-cells
Interval -0.009 to 0.009
|
0.001 percent T-cells
Interval -0.006 to 0.006
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
Nef-CN54
|
-0.003 percent T-cells
Interval -0.005 to 0.003
|
-0.001 percent T-cells
Interval -0.008 to 0.003
|
-0.002 percent T-cells
Interval -0.014 to 0.004
|
0 percent T-cells
Interval -0.006 to 0.003
|
-0.004 percent T-cells
Interval -0.01 to 0.001
|
-0.004 percent T-cells
Interval -0.012 to 0.004
|
-0.001 percent T-cells
Interval -0.009 to 0.007
|
-0.002 percent T-cells
Interval -0.008 to 0.002
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
Pol-1-CN54
|
0.001 percent T-cells
Interval -0.005 to 0.004
|
-0.001 percent T-cells
Interval -0.007 to 0.004
|
0 percent T-cells
Interval -0.007 to 0.005
|
0.001 percent T-cells
Interval -0.004 to 0.008
|
0.001 percent T-cells
Interval -0.006 to 0.005
|
0 percent T-cells
Interval -0.007 to 0.004
|
-0.001 percent T-cells
Interval -0.006 to 0.003
|
-0.001 percent T-cells
Interval -0.005 to 0.002
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
Pol-2-CN54
|
-0.001 percent T-cells
Interval -0.006 to 0.008
|
-0.002 percent T-cells
Interval -0.008 to 0.005
|
-0.001 percent T-cells
Interval -0.012 to 0.009
|
0.001 percent T-cells
Interval -0.004 to 0.006
|
-0.002 percent T-cells
Interval -0.009 to 0.006
|
-0.003 percent T-cells
Interval -0.008 to 0.006
|
-0.001 percent T-cells
Interval -0.005 to 0.006
|
0.001 percent T-cells
Interval -0.005 to 0.008
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
TV1 gp120
|
0.151 percent T-cells
Interval 0.049 to 0.309
|
0.349 percent T-cells
Interval 0.193 to 0.47
|
0.319 percent T-cells
Interval 0.215 to 0.625
|
0.096 percent T-cells
Interval 0.041 to 0.227
|
0.271 percent T-cells
Interval 0.152 to 0.421
|
0.376 percent T-cells
Interval 0.284 to 0.504
|
0.334 percent T-cells
Interval 0.201 to 0.578
|
-0.003 percent T-cells
Interval -0.008 to -0.002
|
|
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.
1086 gp120
|
0.123 percent T-cells
Interval 0.037 to 0.278
|
0.308 percent T-cells
Interval 0.159 to 0.373
|
0.448 percent T-cells
Interval 0.272 to 0.751
|
0.078 percent T-cells
Interval 0.029 to 0.135
|
0.241 percent T-cells
Interval 0.116 to 0.393
|
0.412 percent T-cells
Interval 0.273 to 0.566
|
0.42 percent T-cells
Interval 0.132 to 0.651
|
-0.001 percent T-cells
Interval -0.006 to 0.007
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
ANY HIV
|
2 Participants
|
2 Participants
|
11 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
ANY ENV
|
2 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
ANY POL
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
Gag-ZM96
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
Pol-1-CN54
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
Pol-2-CN54
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
TV1 gp120
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
1086 gp120
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
Env-1-ZM96
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
Env-2-ZM96
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.
Nef-CN54
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=23 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=49 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=46 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=26 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=43 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=42 Participants
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=42 Participants
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3.
Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=21 Participants
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6.
Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
Env-1-ZM96
|
-0.001 percent T-cells
Interval -0.005 to 0.002
|
0.003 percent T-cells
Interval -0.003 to 0.01
|
0.002 percent T-cells
Interval -0.003 to 0.01
|
0.001 percent T-cells
Interval -0.005 to 0.005
|
0.005 percent T-cells
Interval -0.002 to 0.014
|
0.005 percent T-cells
Interval 0.0 to 0.015
|
0.006 percent T-cells
Interval 0.002 to 0.012
|
-0.003 percent T-cells
Interval -0.006 to 0.005
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
Nef-CN54
|
-0.003 percent T-cells
Interval -0.004 to 0.0
|
0 percent T-cells
Interval -0.004 to 0.005
|
0.001 percent T-cells
Interval -0.005 to 0.005
|
0 percent T-cells
Interval -0.003 to 0.003
|
-0.001 percent T-cells
Interval -0.005 to 0.004
|
-0.002 percent T-cells
Interval -0.005 to 0.001
|
-0.001 percent T-cells
Interval -0.004 to 0.006
|
-0.003 percent T-cells
Interval -0.006 to 0.002
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
Pol-1-CN54
|
-0.003 percent T-cells
Interval -0.004 to 0.0
|
0.001 percent T-cells
Interval -0.003 to 0.003
|
0.002 percent T-cells
Interval -0.004 to 0.006
|
-0.002 percent T-cells
Interval -0.004 to 0.002
|
0 percent T-cells
Interval -0.003 to 0.002
|
0 percent T-cells
Interval -0.004 to 0.004
|
0.001 percent T-cells
Interval -0.002 to 0.004
|
0 percent T-cells
Interval -0.005 to 0.003
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
Pol-2-CN54
|
0 percent T-cells
Interval -0.003 to 0.001
|
0.001 percent T-cells
Interval -0.002 to 0.004
|
0.001 percent T-cells
Interval -0.003 to 0.005
|
0 percent T-cells
Interval -0.005 to 0.004
|
-0.001 percent T-cells
Interval -0.005 to 0.003
|
0 percent T-cells
Interval -0.007 to 0.003
|
0 percent T-cells
Interval -0.003 to 0.005
|
-0.003 percent T-cells
Interval -0.005 to 0.0
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
TV1 gp120
|
0 percent T-cells
Interval -0.005 to 0.004
|
0.002 percent T-cells
Interval -0.004 to 0.007
|
0.002 percent T-cells
Interval -0.005 to 0.008
|
0.001 percent T-cells
Interval -0.004 to 0.006
|
0.003 percent T-cells
Interval -0.003 to 0.012
|
0.003 percent T-cells
Interval -0.003 to 0.009
|
0.001 percent T-cells
Interval -0.002 to 0.004
|
0 percent T-cells
Interval -0.005 to 0.005
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
1086 gp120
|
0.003 percent T-cells
Interval -0.002 to 0.01
|
0.002 percent T-cells
Interval -0.003 to 0.01
|
0.002 percent T-cells
Interval -0.004 to 0.014
|
0.005 percent T-cells
Interval -0.002 to 0.013
|
0.001 percent T-cells
Interval -0.003 to 0.014
|
0.001 percent T-cells
Interval -0.003 to 0.009
|
0 percent T-cells
Interval -0.004 to 0.009
|
-0.001 percent T-cells
Interval -0.006 to 0.004
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
ANY HIV
|
0.007 percent T-cells
Interval -0.004 to 0.035
|
0.019 percent T-cells
Interval -0.001 to 0.042
|
0.026 percent T-cells
Interval 0.007 to 0.062
|
0.012 percent T-cells
Interval -0.004 to 0.021
|
0.019 percent T-cells
Interval 0.001 to 0.043
|
0.006 percent T-cells
Interval -0.002 to 0.044
|
0.013 percent T-cells
Interval 0.002 to 0.044
|
-0.004 percent T-cells
Interval -0.011 to 0.009
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
ANY ENV
|
0.006 percent T-cells
Interval -0.001 to 0.014
|
0.011 percent T-cells
Interval 0.003 to 0.019
|
0.013 percent T-cells
Interval 0.004 to 0.037
|
0.01 percent T-cells
Interval 0.003 to 0.021
|
0.008 percent T-cells
Interval 0.002 to 0.032
|
0.009 percent T-cells
Interval 0.005 to 0.022
|
0.009 percent T-cells
Interval 0.003 to 0.02
|
0.004 percent T-cells
Interval -0.001 to 0.009
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
ANY POL
|
-0.002 percent T-cells
Interval -0.006 to 0.001
|
0.002 percent T-cells
Interval -0.005 to 0.013
|
0.002 percent T-cells
Interval -0.006 to 0.01
|
-0.001 percent T-cells
Interval -0.007 to 0.003
|
-0.001 percent T-cells
Interval -0.005 to 0.005
|
0 percent T-cells
Interval -0.009 to 0.006
|
0 percent T-cells
Interval -0.004 to 0.007
|
-0.005 percent T-cells
Interval -0.011 to 0.002
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
Env-2-ZM96
|
0.001 percent T-cells
Interval -0.002 to 0.005
|
0.002 percent T-cells
Interval -0.003 to 0.007
|
0 percent T-cells
Interval -0.003 to 0.007
|
0.005 percent T-cells
Interval 0.0 to 0.01
|
0 percent T-cells
Interval -0.003 to 0.007
|
-0.002 percent T-cells
Interval -0.004 to 0.008
|
0 percent T-cells
Interval -0.004 to 0.006
|
-0.002 percent T-cells
Interval -0.005 to 0.001
|
|
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.
Gag-ZM96
|
0.002 percent T-cells
Interval -0.002 to 0.007
|
0.001 percent T-cells
Interval -0.003 to 0.006
|
0.003 percent T-cells
Interval 0.0 to 0.011
|
0 percent T-cells
Interval -0.003 to 0.004
|
0.002 percent T-cells
Interval -0.002 to 0.006
|
0.001 percent T-cells
Interval -0.002 to 0.01
|
0.002 percent T-cells
Interval -0.003 to 0.007
|
-0.001 percent T-cells
Interval -0.004 to 0.0
|
Adverse Events
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Group 7: Placebo + Protein/AS01B
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Group 8: Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 participants at risk
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
Other adverse events
| Measure |
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
n=30 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 7: Placebo + Protein/AS01B
n=50 participants at risk
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
Group 8: Placebo
n=24 participants at risk
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
13.3%
4/30 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
5/50 • Number of events 7 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Axillary pain
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Hangover
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Influenza like illness
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Injection site pruritus
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
13.3%
4/30 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Injection site warmth
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Peripheral swelling
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
General disorders
Pyrexia
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Immune system disorders
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Any SOC
|
40.0%
12/30 • Number of events 14 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
30.0%
15/50 • Number of events 19 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
40.0%
20/50 • Number of events 32 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
23.3%
7/30 • Number of events 10 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
42.0%
21/50 • Number of events 24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
32.0%
16/50 • Number of events 23 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
24.0%
12/50 • Number of events 15 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
33.3%
8/24 • Number of events 10 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Body tinea
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Ear infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Furuncle
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Mycetoma mycotic
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Proctitis chlamydial
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Sexually transmitted disease
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tinea pedis
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tonsillitis
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
5/30 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.0%
8/50 • Number of events 8 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.0%
8/50 • Number of events 8 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
3/30 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
26.0%
13/50 • Number of events 13 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.0%
8/50 • Number of events 8 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
14.0%
7/50 • Number of events 7 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
25.0%
6/24 • Number of events 6 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Urethritis
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Vaginitis chlamydial
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Viral infection
|
6.7%
2/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Viral rhinitis
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Any SOC
|
6.7%
2/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
5/50 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Injury, poisoning and procedural complications
Wound
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
20.0%
10/50 • Number of events 17 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.0%
8/50 • Number of events 11 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.7%
5/30 • Number of events 6 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
30.0%
15/50 • Number of events 22 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
16.0%
8/50 • Number of events 16 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
5/50 • Number of events 9 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
20.8%
5/24 • Number of events 6 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
14.0%
7/50 • Number of events 11 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 6 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Blood creatinine increased
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
12.0%
6/50 • Number of events 6 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
3/30 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Blood pressure increased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Investigations
Platelet count decreased
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Metabolism and nutrition disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
13.3%
4/30 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 9 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Any SOC
|
6.7%
2/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Pregnancy, puerperium and perinatal conditions
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Psychiatric disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Psychiatric disorders
Alcoholic hangover
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Psychiatric disorders
Depression
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Any SOC
|
6.7%
2/30 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 7 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
3/30 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Haematuria
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.7%
2/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
2/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.7%
2/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Any SOC
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Any SOC
|
10.0%
3/30 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
3/30 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
12.0%
6/50 • Number of events 6 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
12.0%
6/50 • Number of events 8 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.2%
1/24 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.3%
1/30 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Vascular disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Vascular disorders
Hot flush
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Vascular disorders
Peripheral coldness
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Blood and lymphatic system disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
6.0%
3/50 • Number of events 3 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Ear and labyrinth disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Eye disorders
Any SOC
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Eye disorders
Eye irritation
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
2.0%
1/50 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Eye disorders
Eye pruritus
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/30 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/50 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
0.00%
0/24 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
|
Gastrointestinal disorders
Any SOC
|
6.7%
2/30 • Number of events 7 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.0%
4/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
3.3%
1/30 • Number of events 1 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 4 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
10.0%
5/50 • Number of events 5 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
4.0%
2/50 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
8.3%
2/24 • Number of events 2 • Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place