Trial Outcomes & Findings for A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults (NCT NCT05470400)
NCT ID: NCT05470400
Last Updated: 2025-03-21
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Results posted on
2025-03-21
Participant Flow
Participant milestones
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
10
|
10
|
9
|
|
Overall Study
COMPLETED
|
2
|
3
|
3
|
3
|
3
|
9
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
Baseline Characteristics
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
34 years
n=7 Participants
|
42 years
n=5 Participants
|
24 years
n=4 Participants
|
32 years
n=21 Participants
|
25.5 years
n=8 Participants
|
31 years
n=8 Participants
|
37 years
n=24 Participants
|
28.5 years
n=42 Participants
|
|
Age, Customized
18 - 20 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
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Age, Customized
21 - 30 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Age, Customized
31 - 40 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Age, Customized
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
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Transgender Male (Female to Male)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Transgender Female (Male to Female)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Gender Queer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
34 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
USA
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
44 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
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
Mild
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Potentially 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 (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Potentially 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: Erythema and/or Induration
Induration/Swelling · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
6 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
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/Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Potentially 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: Erythema and/or Induration
Erythema and/or Induration · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially 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 (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise a
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 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
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 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
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 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
Chills · None
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 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
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms* · Mild
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms* · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms* · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 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
Temperature · None
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment arm for each post vaccination time point.
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 147
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 154
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 91
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 147
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 154
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 231
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 238
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 259
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 14
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 63
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 154
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 91
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 147
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 154
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 231
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 238
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Creatinine (mg/dL) -Day 259
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 63
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 63
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 91
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 28
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 63
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 91
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 147
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 154
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 231
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 238
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
ALT (U/L) -Day 259
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Hemoglobin (g/dL) -Day 63
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 147
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 231
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 238
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
WBC (1000 cells/cubic mm) -Day 259
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 91
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 147
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 154
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 63
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 91
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 231
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 238
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 231
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 238
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Platelets (1000 cells/cubic mm) -Day 259
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 63
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 84
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 91
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 140
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 147
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 154
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 168
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 231
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 238
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Lymphocytes (1000 cells/cubic mm) -Day 259
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Neutrophils (1000 cells/cubic mm) -Day 259
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
No AE reported
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Related
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Not Related
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
No AE reported
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
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: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 Participants
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 Participants
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 Participants
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 Participants
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 Participants
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
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 at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.Population: Overall Number of Participants Analyzed- includes those with samples collected at week 2 for Groups T5+T6, T7, and T8 and week 6 for Groups T7 and T8, who were HIV-uninfected and received the last vaccination. Number Analyzed- counts participants with available data after filtering for assay-specific quality control criteria.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3\*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV\>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. Group 5 and Group 6 were combined in the summary of IgG response rate.
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=12 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=8 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=8 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Fusion Peptide (W2) Positivity call method 1
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Fusion Peptide (W2) Positivity call method 2
|
1 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Fusion Peptide (W6) Positivity call method 1
|
—
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Fusion Peptide (W6) Positivity call method 2
|
—
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 4571 (W2) Positivity call method 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 4571 (W2) Positivity call method 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 4571 (W6) Positivity call method 1
|
—
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 4571 (W6) Positivity call method 2
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 6931 (W2) Positivity call method 1
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 6931 (W2) Positivity call method 2
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 6931 (W6) Positivity call method 1
|
—
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 6931 (W6) Positivity call method 2
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.Population: Overall Number of Participants Analyzed- includes those with samples collected at week 2 for Groups T5+T6, T7, and T8 and week 6 for Groups T7 and T8, who were HIV-uninfected and received the last vaccination. Number Analyzed- counts participants with available data after filtering for assay-specific quality control criteria.
Meso Scale Discovery Immunogenicity Assay (MSD) was used to measure the IgG binding antibody responses to fusion protein (FP), Trimer 4571, and Trimer 6931 based on two distinct positivity call methods: Method 1, known for its liberal approach, and Method 2, acknowledged for its conservative nature. Method 1 is using the cutoffs from the lab based on the 80 naïve samples (the 95th percentile). Method 2 is using the cutoffs (mean + 3\*SD of AUC to each analyte) based on the 80 naïve samples after filtering out %CV\>= 30% plus the baseline values from this study. The readout was the area under the curve (AUC) that were calculated from 8 serial dilutions (8-fold) for each sample. The Unit of Measure is expressed as Mean Electrochemiluminescence Signal\*1/dilution to reflect the AUC of responses across serial dilutions. Group 5 and Group 6 were combined in the summary of IgG magnitudes.
Outcome measures
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=12 Participants
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=8 Participants
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=8 Participants
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Fusion Peptide (W2)
|
447.40 Mean ECL Signal*1/dilution
Interval 276.1 to 663.0
|
1462.00 Mean ECL Signal*1/dilution
Interval 596.3 to 2334.5
|
557.30 Mean ECL Signal*1/dilution
Interval 380.6 to 1216.8
|
—
|
—
|
—
|
—
|
—
|
|
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Fusion Peptide (W6)
|
—
|
9463.00 Mean ECL Signal*1/dilution
Interval 7766.8 to 12143.8
|
8568.50 Mean ECL Signal*1/dilution
Interval 5487.0 to 10460.5
|
—
|
—
|
—
|
—
|
—
|
|
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 4571 (W2)
|
124.60 Mean ECL Signal*1/dilution
Interval 84.7 to 165.3
|
61.70 Mean ECL Signal*1/dilution
Interval 56.6 to 118.6
|
87.80 Mean ECL Signal*1/dilution
Interval 68.8 to 138.5
|
—
|
—
|
—
|
—
|
—
|
|
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 4571 (W6)
|
—
|
236.40 Mean ECL Signal*1/dilution
Interval 143.2 to 367.2
|
1192.00 Mean ECL Signal*1/dilution
Interval 744.5 to 1945.0
|
—
|
—
|
—
|
—
|
—
|
|
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 6931 (W2)
|
175.60 Mean ECL Signal*1/dilution
Interval 107.2 to 218.6
|
106.30 Mean ECL Signal*1/dilution
Interval 90.9 to 149.4
|
118.70 Mean ECL Signal*1/dilution
Interval 99.4 to 179.5
|
—
|
—
|
—
|
—
|
—
|
|
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Trimer 6931 (W6)
|
—
|
103.00 Mean ECL Signal*1/dilution
Interval 87.8 to 192.0
|
572.10 Mean ECL Signal*1/dilution
Interval 414.7 to 677.5
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Group 5: 200 mcg Trimer 4571 at w(0)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 participants at risk
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 participants at risk
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 participants at risk
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 participants at risk
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 participants at risk
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 participants at risk
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 participants at risk
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 participants at risk
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
Other adverse events
| Measure |
Part A, Group 1: 25 mcg FP Conjugate Vaccine at w(0)
n=3 participants at risk
25 mcg FP Conjugate Vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 2: 200 mcg FP Conjugate Vaccine at w(0)
n=3 participants at risk
200 mcg FP conjugate vaccine (FP8v1-rTTHC; VRC-HIVVCP0108-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 3: 100 mcg Trimer 6931 at w(0)
n=3 participants at risk
100 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part A, Group 4: 200 mcg Trimer 6931 at w(0)
n=3 participants at risk
200 mcg Trimer 6931 (HIV-1 Trimer 6931 Vaccine; VRC-HIVRGP0106-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL), intramuscularly at Week 0.
|
Part A Group 5: 200 mcg Trimer 4571 at w(0)
n=3 participants at risk
200 mcg Trimer 4571 (HIV-1 Trimer 4571 Vaccine; VRC-HIVRGP096-00-VP) + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0.
|
Part B, Group 6: 200 mcg Trimer 4571 at w(0)
n=10 participants at risk
200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), intramuscularly at Week 0
|
Part B, Group 7: 200 mcg FP Conjugate Vaccine at w(0, 4)
n=10 participants at risk
200 mcg FP conjugate vaccine + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
Part B, Group 8: 200 mcg FP Conjugate Vaccine + 200 mcg Trimer 4571 at w(0, 4)
n=9 participants at risk
200 mcg FP conjugate vaccine + 200 mcg Trimer 4571 + 20% dose/volume (d/v) Adjuplex, to be administered as 0.8 mL, divided into 2 syringes (0.4 mL each), at Weeks 0 and 4
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
30.0%
3/10 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
30.0%
3/10 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
66.7%
6/9 • Number of events 6 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Axillary pain
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Chills (Solicited)
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
30.0%
3/10 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
90.0%
9/10 • Number of events 9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
9/9 • Number of events 9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Fatigue (Solicited)
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
66.7%
2/3 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
66.7%
2/3 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
10/10 • Number of events 10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
10/10 • Number of events 10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
9/9 • Number of events 9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Injection site erythema (Solicited)
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
30.0%
3/10 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
22.2%
2/9 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Injection site induration
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Injection site pain (Solicited)
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
10/10 • Number of events 10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
10/10 • Number of events 10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
9/9 • Number of events 9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Injection site rash
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
General disorders
Injection site swelling (Solicited)
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
3/9 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Immune system disorders
Serum sickness
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
20.0%
2/10 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Investigations
Body temperature increased (Solicited)
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
20.0%
2/10 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
50.0%
5/10 • Number of events 5 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
77.8%
7/9 • Number of events 7 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Solicited)
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
66.7%
2/3 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
66.7%
2/3 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
50.0%
5/10 • Number of events 5 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
60.0%
6/10 • Number of events 6 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
77.8%
7/9 • Number of events 7 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
66.7%
2/3 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
70.0%
7/10 • Number of events 7 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
80.0%
8/10 • Number of events 8 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
77.8%
7/9 • Number of events 7 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Nervous system disorders
Headache (Solicited)
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
66.7%
2/3 • Number of events 2 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
100.0%
3/3 • Number of events 3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
70.0%
7/10 • Number of events 7 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
90.0%
9/10 • Number of events 9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
88.9%
8/9 • Number of events 8 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Reproductive system and breast disorders
Cervix inflammation
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
10.0%
1/10 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
11.1%
1/9 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/3 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
33.3%
1/3 • Number of events 1 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/10 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
0.00%
0/9 • SAEs, medically attended adverse events (MAAEs), adverse events of special interest (AESIs) and AEs leading to early participant withdrawal or permanent discontinuation were collected throughout the study and for 12 months following any receipt of study product. Other unsolicited AEs were collected for 28 days after any receipt of study vaccination. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination.
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place