Trial Outcomes & Findings for Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants (NCT NCT04607408)
NCT ID: NCT04607408
Last Updated: 2026-01-29
Results Overview
At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score will be calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. This Outcome Measure was not collected for Mothers.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Measured at each study visit.
Results posted on
2026-01-29
Participant Flow
This study enrolled 38 mother-infant pairs. Mothers were also enrolled to assess maternal HIV antibody response but did not receive study product. All mother-infant pairs were assigned to Groups as a unit. The values reported reflect the number of infants, who were the primary participants. Each infant corresponds to one unique mother, so the number of mothers equals the number of infants.
Participant milestones
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
2
|
16
|
5
|
|
Overall Study
COMPLETED
|
10
|
4
|
2
|
14
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants
Baseline characteristics by cohort
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Age, Continuous
|
31.5 years
n=35 Participants
|
36 years
n=4328 Participants
|
36 years
n=8687 Participants
|
34.5 years
n=153 Participants
|
33 years
n=200 Participants
|
34 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
16 Participants
n=153 Participants
|
5 Participants
n=200 Participants
|
38 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
16 Participants
n=153 Participants
|
5 Participants
n=200 Participants
|
38 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
16 Participants
n=153 Participants
|
5 Participants
n=200 Participants
|
38 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=12 Participants
|
|
Region of Enrollment
South Africa
|
10 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
16 Participants
n=153 Participants
|
5 Participants
n=200 Participants
|
38 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Measured at each study visit.Population: Safety population
At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score will be calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length. This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
14 Days Post Vaccination 2
|
-0.50 Z-scores
Interval -2.04 to 1.68
|
0.22 Z-scores
Interval -1.78 to 0.7
|
-1.30 Z-scores
Interval -1.4 to -1.2
|
0.02 Z-scores
Interval -1.23 to 1.52
|
-0.04 Z-scores
Interval -0.47 to 0.68
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
Month 8/Prior to Vaccination 4
|
0.12 Z-scores
Interval -2.02 to 1.72
|
-0.76 Z-scores
Interval -1.37 to 0.76
|
-1.69 Z-scores
Interval -1.89 to -1.49
|
-0.09 Z-scores
Interval -1.08 to 2.24
|
0.60 Z-scores
Interval -0.72 to 1.73
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
14 Days Post Vaccination 5
|
-0.18 Z-scores
Interval -1.74 to 1.6
|
-0.39 Z-scores
Interval -1.9 to 0.12
|
-1.20 Z-scores
Interval -1.2 to -1.2
|
0.52 Z-scores
Interval -1.49 to 2.29
|
0.14 Z-scores
Interval -0.43 to 1.87
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
4.5 Months Post Vaccination 5
|
-0.27 Z-scores
Interval -1.87 to 1.48
|
-1.17 Z-scores
Interval -2.38 to 0.21
|
-1.28 Z-scores
Interval -1.37 to -1.18
|
-0.11 Z-scores
Interval -1.24 to 2.01
|
1.08 Z-scores
Interval -0.33 to 2.53
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
Screening Visit
|
-0.32 Z-scores
Interval -1.15 to 1.47
|
-0.80 Z-scores
Interval -1.54 to 0.51
|
-1.59 Z-scores
Interval -2.1 to -1.08
|
-0.29 Z-scores
Interval -1.47 to 0.82
|
0.60 Z-scores
Interval -1.22 to 0.87
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
Month 0/Prior to Vaccination 1
|
-0.54 Z-scores
Interval -1.9 to 1.39
|
-1.16 Z-scores
Interval -1.51 to 0.45
|
-1.36 Z-scores
Interval -1.72 to -0.99
|
-0.47 Z-scores
Interval -2.41 to 1.46
|
0.06 Z-scores
Interval -1.25 to 0.74
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
1 Day Post Vaccination 1
|
-0.47 Z-scores
Interval -1.96 to 1.28
|
-1.13 Z-scores
Interval -1.57 to 0.39
|
-1.39 Z-scores
Interval -1.81 to -0.96
|
-0.44 Z-scores
Interval -1.31 to 0.52
|
-0.05 Z-scores
Interval -1.09 to 0.73
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
14 Days Post Vaccination 1
|
-0.50 Z-scores
Interval -2.14 to 1.42
|
-0.53 Z-scores
Interval -1.55 to 0.89
|
-1.02 Z-scores
Interval -1.09 to -0.95
|
-0.29 Z-scores
Interval -1.37 to 0.83
|
0.03 Z-scores
Interval -0.61 to 0.4
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
Month 2/Prior to Vaccination 2
|
-0.25 Z-scores
Interval -2.06 to 1.44
|
0.15 Z-scores
Interval -1.8 to 0.98
|
-1.27 Z-scores
Interval -1.34 to -1.2
|
-0.34 Z-scores
Interval -1.47 to 1.3
|
0.07 Z-scores
Interval -0.54 to 0.55
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
Month 4/Prior to Vaccination 3
|
-0.04 Z-scores
Interval -2.2 to 1.64
|
-0.44 Z-scores
Interval -1.02 to 0.35
|
-1.43 Z-scores
Interval -1.69 to -1.16
|
-0.38 Z-scores
Interval -1.39 to 1.67
|
-0.31 Z-scores
Interval -3.16 to 1.05
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
14 Days Post Vaccination 3
|
0.11 Z-scores
Interval -1.49 to 1.78
|
-0.56 Z-scores
Interval -1.34 to 0.37
|
-1.41 Z-scores
Interval -1.43 to -1.39
|
-0.39 Z-scores
Interval -1.56 to 1.69
|
0.24 Z-scores
Interval -0.33 to 1.1
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
14 Days Post Vaccination 4
|
0.23 Z-scores
Interval -1.82 to 1.67
|
-0.69 Z-scores
Interval -1.41 to 0.75
|
-1.71 Z-scores
Interval -1.73 to -1.69
|
-0.04 Z-scores
Interval -1.28 to 2.29
|
-0.20 Z-scores
Interval -0.72 to 1.59
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
Month 12.5/Prior to Vaccination 5
|
-0.03 Z-scores
Interval -1.87 to 1.67
|
-0.25 Z-scores
Interval -1.83 to 0.13
|
-1.30 Z-scores
Interval -1.32 to -1.27
|
0.29 Z-scores
Interval -1.61 to 2.2
|
-0.14 Z-scores
Interval -0.48 to 1.35
|
|
WHO Anthropometric Measure of Weight-for-Age Z-Score
12.5 Months Post Vaccination 5
|
-0.05 Z-scores
Interval -1.83 to 1.32
|
-0.70 Z-scores
Interval -2.06 to -0.37
|
-0.08 Z-scores
Interval -0.89 to 0.74
|
0.14 Z-scores
Interval -1.03 to 1.64
|
0.24 Z-scores
Interval -0.48 to 0.97
|
PRIMARY outcome
Timeframe: Measured at each study visit.Population: Safety population
At each study visit, the infant's weight was measured. Using weight and age, a WHO weight-for-age z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-age reflects body weight relative to the child's age on a given day. Z-scores less than -2 indicates an infant who is underweight, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant may have a growth problem, but this is better assessed from weight-for-length.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (Screening Visit)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (Month 0/Prior to Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (1 Day Post Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (14 Days Post Vaccination 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (14 Days Post Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (Month 4/Prior to Vaccination 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (14 Days Post Vaccination 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (14 Days Post Vaccination 3)
|
9 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
4 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (14 Days Post Vaccination 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (14 Days Post Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (14 Days Post Vaccination 5)
|
9 Participants
|
5 Participants
|
1 Participants
|
12 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (4.5 Months Post Vaccination 5)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (4.5 Months Post Vaccination 5)
|
10 Participants
|
3 Participants
|
2 Participants
|
13 Participants
|
4 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (14 Days Post Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (4.5 Months Post Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (12.5 Months Post Vaccination 5)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (12.5 Months Post Vaccination 5)
|
10 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (12.5 Months Post Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (Screening Visit)
|
10 Participants
|
5 Participants
|
1 Participants
|
16 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (Screening Visit)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (Month 0/Prior to Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (Month 0/Prior to Vaccination 1)
|
10 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (1 Day Post Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (1 Day Post Vaccination 1)
|
10 Participants
|
5 Participants
|
2 Participants
|
16 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (14 Days Post Vaccination 1)
|
9 Participants
|
5 Participants
|
2 Participants
|
16 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (Month 2/Prior to Vaccination 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (Month 2/Prior to Vaccination 2)
|
9 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (Month 2/Prior to Vaccination 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (14 Days Post Vaccination 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (14 Days Post Vaccination 2)
|
9 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (14 Days Post Vaccination 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (Month 4/Prior to Vaccination 3)
|
8 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (Month 4/Prior to Vaccination 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (14 Days Post Vaccination 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (Month 8/Prior to Vaccination 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (Month 8/Prior to Vaccination 4)
|
9 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (Month 8/Prior to Vaccination 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (14 Days Post Vaccination 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (14 Days Post Vaccination 4)
|
10 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
<-2 (Month 12.5/Prior to Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
-2 to 2 (Month 12.5/Prior to Vaccination 5)
|
10 Participants
|
5 Participants
|
2 Participants
|
12 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Age Z-Score Categories
>2 (Month 12.5/Prior to Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at each study visit.Population: Safety population
At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. A Z-score of 0 represents the population mean, a Z-score less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight. This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
Screening Visit
|
0.97 Z-scores
Interval -1.19 to 2.32
|
-0.95 Z-scores
Interval -1.63 to 1.08
|
-2.30 Z-scores
Interval -2.37 to -2.22
|
0.50 Z-scores
Interval -4.04 to 2.84
|
0.93 Z-scores
Interval -2.94 to 1.75
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
14 Days Post Vaccination 2
|
1.14 Z-scores
Interval 0.04 to 2.2
|
1.11 Z-scores
Interval -0.33 to 2.85
|
0.88 Z-scores
Interval 0.67 to 1.08
|
1.41 Z-scores
Interval 0.1 to 3.36
|
1.88 Z-scores
Interval 0.57 to 2.65
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
14 Days Post Vaccination 4
|
1.11 Z-scores
Interval -1.13 to 3.0
|
0.68 Z-scores
Interval -0.07 to 1.52
|
0.18 Z-scores
Interval -0.62 to 0.97
|
0.69 Z-scores
Interval -1.07 to 2.83
|
0.45 Z-scores
Interval 0.3 to 2.6
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
Month 12.5/Prior to Vaccination 5
|
0.96 Z-scores
Interval -1.27 to 3.25
|
0.91 Z-scores
Interval -0.1 to 1.72
|
-0.04 Z-scores
Interval -0.52 to 0.44
|
0.79 Z-scores
Interval -0.56 to 2.79
|
1.39 Z-scores
Interval -0.59 to 2.72
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
14 Days Post Vaccination 5
|
0.66 Z-scores
Interval -0.96 to 2.6
|
0.93 Z-scores
Interval -0.39 to 1.83
|
0.63 Z-scores
Interval 0.63 to 0.63
|
0.65 Z-scores
Interval -0.45 to 2.93
|
1.71 Z-scores
Interval -0.41 to 2.58
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
4.5 Months Post Vaccination 5
|
0.68 Z-scores
Interval -1.27 to 2.44
|
0.08 Z-scores
Interval -0.59 to 1.29
|
-0.36 Z-scores
Interval -0.58 to -0.13
|
0.89 Z-scores
Interval -0.4 to 2.25
|
0.79 Z-scores
Interval -0.61 to 2.69
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
Month 0/Prior to Vaccination 1
|
0.20 Z-scores
Interval -1.51 to 1.57
|
-0.44 Z-scores
Interval -1.63 to 1.08
|
-0.68 Z-scores
Interval -1.47 to 0.11
|
0.02 Z-scores
Interval -1.27 to 1.73
|
0.44 Z-scores
Interval -2.37 to 1.56
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
1 Day Post Vaccination 1
|
0.40 Z-scores
Interval -1.4 to 1.69
|
0.44 Z-scores
Interval -1.47 to 1.7
|
-0.58 Z-scores
Interval -1.43 to 0.27
|
0.06 Z-scores
Interval -1.5 to 1.68
|
0.05 Z-scores
Interval -2.17 to 1.33
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
14 Days Post Vaccination 1
|
0.53 Z-scores
Interval -1.02 to 2.82
|
0.84 Z-scores
Interval -1.8 to 1.16
|
0.50 Z-scores
Interval -0.01 to 1.0
|
0.74 Z-scores
Interval -0.79 to 3.1
|
0.47 Z-scores
Interval 0.14 to 1.76
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
Month 2/Prior to Vaccination 2
|
1.07 Z-scores
Interval 0.54 to 3.36
|
2.43 Z-scores
Interval -0.2 to 4.95
|
0.89 Z-scores
Interval 0.35 to 1.42
|
1.60 Z-scores
Interval -0.09 to 3.21
|
1.25 Z-scores
Interval 0.62 to 3.71
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
Month 4/Prior to Vaccination 3
|
1.55 Z-scores
Interval 0.1 to 2.17
|
0.91 Z-scores
Interval 0.21 to 1.48
|
0.82 Z-scores
Interval 0.23 to 1.41
|
1.04 Z-scores
Interval -1.26 to 4.41
|
0.99 Z-scores
Interval 0.21 to 3.85
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
14 Days Post Vaccination 3
|
1.55 Z-scores
Interval -0.06 to 2.21
|
0.48 Z-scores
Interval -0.52 to 1.98
|
-0.02 Z-scores
Interval -0.69 to 0.65
|
1.16 Z-scores
Interval -0.99 to 2.91
|
0.69 Z-scores
Interval 0.27 to 2.15
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
Month 8/Prior to Vaccination 4
|
1.07 Z-scores
Interval -1.42 to 2.88
|
0.67 Z-scores
Interval 0.56 to 1.83
|
-0.49 Z-scores
Interval -0.82 to -0.16
|
1.01 Z-scores
Interval -0.96 to 2.71
|
0.96 Z-scores
Interval 0.44 to 2.9
|
|
WHO Anthropometric Measure of Weight-for-Length Z-Score
12.5 Months Post Vaccination 5
|
1.06 Z-scores
Interval -1.26 to 2.24
|
0.72 Z-scores
Interval 0.0 to 0.83
|
0.59 Z-scores
Interval 0.34 to 0.83
|
1.05 Z-scores
Interval -0.2 to 2.27
|
1.70 Z-scores
Interval -0.26 to 3.0
|
PRIMARY outcome
Timeframe: Measured at each study visit.Population: Safety population
At each study visit, the infant's length and weight was measured. Using these measurements, a WHO weight-for-length z-score was calculated using the World Health Organization (WHO) anthropometric calculator tool. Weight-for-length reflects body weight in proportion to attained growth in length. Z-scores less than -2 indicates an infant who is wasted, -2 to 2 indicates an infant who is normal weight, and above 2 indicates the infant is overweight.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (Screening Visit)
|
8 Participants
|
5 Participants
|
0 Participants
|
12 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (Screening Visit)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (1 Day Post Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (1 Day Post Vaccination 1)
|
10 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
4 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (Month 4/Prior to Vaccination 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (Screening Visit)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (Month 0/Prior to Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (Month 0/Prior to Vaccination 1)
|
10 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (Month 0/Prior to Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (1 Day Post Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (14 Days Post Vaccination 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (14 Days Post Vaccination 1)
|
9 Participants
|
5 Participants
|
2 Participants
|
14 Participants
|
5 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (14 Days Post Vaccination 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (Month 2/Prior to Vaccination 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (Month 2/Prior to Vaccination 2)
|
8 Participants
|
1 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (Month 2/Prior to Vaccination 2)
|
2 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (14 Days Post Vaccination 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (14 Days Post Vaccination 2)
|
9 Participants
|
4 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (14 Days Post Vaccination 2)
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (Month 4/Prior to Vaccination 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (Month 4/Prior to Vaccination 3)
|
8 Participants
|
5 Participants
|
2 Participants
|
12 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (14 Days Post Vaccination 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (14 Days Post Vaccination 3)
|
7 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (14 Days Post Vaccination 3)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (Month 8/Prior to Vaccination 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (Month 8/Prior to Vaccination 4)
|
8 Participants
|
5 Participants
|
2 Participants
|
12 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (Month 8/Prior to Vaccination 4)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (14 Days Post Vaccination 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (14 Days Post Vaccination 4)
|
8 Participants
|
5 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (14 Days Post Vaccination 4)
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (Month 12.5/Prior to Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (Month 12.5/Prior to Vaccination 5)
|
8 Participants
|
5 Participants
|
2 Participants
|
12 Participants
|
4 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (Month 12.5/Prior to Vaccination 5)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (14 Days Post Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (14 Days Post Vaccination 5)
|
7 Participants
|
5 Participants
|
1 Participants
|
12 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (14 Days Post Vaccination 5)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (4.5 Months Post Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (4.5 Months Post Vaccination 5)
|
9 Participants
|
4 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (4.5 Months Post Vaccination 5)
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
<-2 (12.5 Months Post Vaccination 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
-2 to 2 (12.5 Months Post Vaccination 5)
|
9 Participants
|
3 Participants
|
2 Participants
|
12 Participants
|
3 Participants
|
|
Number (Percentage) of Participants by WHO Anthropometric Measure of Weight-for-Length Z-Score Categories
>2 (12.5 Months Post Vaccination 5)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).Population: Safety population
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. This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
9 Participants
|
4 Participants
|
2 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 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
|
|
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
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).Population: Safety population
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. This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · None
|
10 Participants
|
3 Participants
|
2 Participants
|
16 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Mild
|
0 Participants
|
2 Participants
|
0 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
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/swelling · None
|
10 Participants
|
5 Participants
|
2 Participants
|
16 Participants
|
5 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
|
|
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
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
10 Participants
|
3 Participants
|
2 Participants
|
16 Participants
|
5 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
|
|
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
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 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
|
|
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
|
0 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
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine dose (Weeks 0, 8, 16, 32, 54).Population: Safety population
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: fever, sleepiness/lethargy, rash, vomiting, anorexia, seizure. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities for a participant. This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Rash · None
|
8 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Seizure · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Seizure · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Sleepiness/lethargy · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Anorexia · None
|
9 Participants
|
5 Participants
|
2 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Anorexia · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Anorexia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Anorexia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Anorexia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Fever · None
|
8 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Fever · Mild
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Fever · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Fever · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Fever · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Rash · Mild
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Rash · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Rash · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Rash · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Seizure · None
|
10 Participants
|
5 Participants
|
2 Participants
|
16 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Seizure · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Seizure · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Sleepiness/lethargy · None
|
7 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Sleepiness/lethargy · Mild
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Sleepiness/lethargy · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Sleepiness/lethargy · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
10 Participants
|
4 Participants
|
2 Participants
|
15 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Sypmtoms · None
|
6 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Sypmtoms · Mild
|
4 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Sypmtoms · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Sypmtoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Sypmtoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: ALT, creatinine, hemoglobin, platelets, and WBC measured at Screening (Day 0) and Days 14, 70, 126, 238, 393, 743; Lymphocytes and Neutrophils measured at Days 14, 70, 126, 238, 393, 743.Population: '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. This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
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
|
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.
Creatinine (mg/dL) - Day 393
|
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
|
|
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 743
|
2 Participants
|
1 Participants
|
1 Participants
|
2 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 (cells/cubic mm) - Day 126
|
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 (cells/cubic mm) - Day 743
|
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 (cells/cubic mm) - Day 14
|
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.
Neutrophils (cells/cubic mm) - Day 126
|
2 Participants
|
2 Participants
|
0 Participants
|
2 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 (cells/cubic mm) - Day 238
|
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.
Neutrophils (cells/cubic mm) - Day 393
|
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.
Neutrophils (cells/cubic mm) - Day 743
|
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 (cells/cubic mm) - Screening
|
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 (cells/cubic mm) - Day 14
|
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 (cells/cubic mm) - Day 70
|
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 (cells/cubic mm) - Day 14
|
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 (cells/cubic mm) - Day 126
|
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 (cells/cubic mm) - Day 238
|
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 (cells/cubic mm) - Day 393
|
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
|
|
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 126
|
2 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
|
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.
ALT (U/L) - Day 393
|
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 743
|
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 126
|
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
|
|
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 743
|
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
|
7 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
3 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
|
4 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
3 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 126
|
2 Participants
|
0 Participants
|
1 Participants
|
2 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
|
1 Participants
|
0 Participants
|
2 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 393
|
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.
Lymphocytes (cells/cubic mm) - Day 14
|
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 (cells/cubic mm) - Day 70
|
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 (cells/cubic mm) - Day 238
|
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 (cells/cubic mm) - Day 393
|
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 (cells/cubic mm) - Day 70
|
1 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.
Platelets (cells/cubic mm) - Day 126
|
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.
Platelets (cells/cubic mm) - Day 238
|
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 (cells/cubic mm) - Day 393
|
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 (cells/cubic mm) - Day 743
|
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 (cells/cubic mm) - Screening
|
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 (cells/cubic mm) - Day 70
|
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 (cells/cubic mm) - Day 743
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months.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). This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
No AE reported
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
Moderate
|
5 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants Reporting AEs, by Highest Severity Grade Per Participant.
Severe
|
4 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months.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). This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
No AE reported
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Related
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Not Related
|
9 Participants
|
5 Participants
|
2 Participants
|
16 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months.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). This Outcome Measure was not collected for Mothers.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
Serum HIV-1-specific IgG responses were measured on a BioPlex instrument (BioRad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. The area under the curve (AUC) was calculated for each participant and antigen using the trapezoidal rule, where the x-axis is log10 dilution and the y-axis is the Net MFI with negative values set to 0. AUC is considered the primary measure of response magnitude.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination
1086C D7gp120
|
5.2 net MFI*log10(dilution)
Interval 3.2 to 8.4
|
16956.7 net MFI*log10(dilution)
Interval 16512.5 to 26189.1
|
24059.2 net MFI*log10(dilution)
Interval 21832.9 to 30626.7
|
24508.6 net MFI*log10(dilution)
Interval 17065.5 to 26209.8
|
—
|
|
Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination
CH0505 CON D7gp120
|
3 net MFI*log10(dilution)
Interval 1.4 to 6.5
|
7675.3 net MFI*log10(dilution)
Interval 6092.5 to 13038.8
|
16065.3 net MFI*log10(dilution)
Interval 12036.4 to 24331.6
|
16516.7 net MFI*log10(dilution)
Interval 15930.1 to 19086.2
|
—
|
|
Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination
CH505TF.6R.SOSIP.664.v4.1
|
19 net MFI*log10(dilution)
Interval 2.9 to 221.5
|
50.8 net MFI*log10(dilution)
Interval 0.2 to 107.8
|
71.8 net MFI*log10(dilution)
Interval 17.4 to 236.6
|
167.8 net MFI*log10(dilution)
Interval 93.8 to 188.1
|
—
|
|
Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination
Con 6 gp120/B
|
7.5 net MFI*log10(dilution)
Interval 3.1 to 8.3
|
2333.2 net MFI*log10(dilution)
Interval 2327.7 to 2708.0
|
9386.3 net MFI*log10(dilution)
Interval 3803.9 to 15816.8
|
5373.1 net MFI*log10(dilution)
Interval 4490.3 to 6747.2
|
—
|
|
Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination
Con S gp140 CFI
|
7.2 net MFI*log10(dilution)
Interval 6.3 to 31.0
|
8289.3 net MFI*log10(dilution)
Interval 2393.4 to 8637.3
|
13322.4 net MFI*log10(dilution)
Interval 11569.8 to 23320.6
|
17231.6 net MFI*log10(dilution)
Interval 11565.6 to 26860.3
|
—
|
|
Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination
gp41
|
2842.4 net MFI*log10(dilution)
Interval 2098.3 to 6013.8
|
1670.1 net MFI*log10(dilution)
Interval 1031.3 to 2167.9
|
2462 net MFI*log10(dilution)
Interval 1603.2 to 3552.0
|
2251.7 net MFI*log10(dilution)
Interval 2095.7 to 2592.4
|
—
|
|
Magnitude of HIV-1 Env gp120, CD4 Binding Site and V1V2-specific Serum IgG Binding Antibodies, as Assessed by BAMA Two Weeks After the 5th Vaccination
gp70 CH505TF V1V2
|
36.8 net MFI*log10(dilution)
Interval 1.9 to 91.3
|
2500.7 net MFI*log10(dilution)
Interval 826.8 to 8369.1
|
5768.7 net MFI*log10(dilution)
Interval 3342.3 to 9254.4
|
8417 net MFI*log10(dilution)
Interval 7400.9 to 22426.2
|
—
|
PRIMARY outcome
Timeframe: Measured at month 4.5 (2 weeks post the 3rd vaccination).Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 3rd vaccination, who were HIV-uninfected and received the 3rd vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=4 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=17 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=4 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CD4-BS specific of B cells
|
0.01 Percentage of B cells
Interval 0.01 to 0.01
|
0.02 Percentage of B cells
Interval 0.01 to 0.03
|
0.01 Percentage of B cells
Interval 0.01 to 0.01
|
0.01 Percentage of B cells
Interval 0.01 to 0.02
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CD4-BS specific of IgA B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.12
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CD4-BS specific of IgD- B cells
|
0 Percentage of B cells
Interval 0.0 to 0.01
|
0.25 Percentage of B cells
Interval 0.06 to 0.48
|
0.03 Percentage of B cells
Interval 0.02 to 0.1
|
0.12 Percentage of B cells
Interval 0.03 to 0.36
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CD4-BS specific of IgG+ B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0.71 Percentage of B cells
Interval 0.18 to 1.41
|
0.39 Percentage of B cells
Interval 0.08 to 0.62
|
0.31 Percentage of B cells
Interval 0.06 to 0.77
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CD4-BS specific of Plasmablasts
|
0.05 Percentage of B cells
Interval 0.0 to 0.06
|
0.03 Percentage of B cells
Interval 0.0 to 0.07
|
0 Percentage of B cells
Interval 0.0 to 0.02
|
0 Percentage of B cells
Interval 0.0 to 0.02
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CH505+ of B cells
|
0.01 Percentage of B cells
Interval 0.01 to 0.01
|
0.09 Percentage of B cells
Interval 0.06 to 0.12
|
0.03 Percentage of B cells
Interval 0.02 to 0.05
|
0.06 Percentage of B cells
Interval 0.05 to 0.08
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CH505+ of IgA+ B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.04
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0.18 Percentage of B cells
Interval 0.0 to 0.51
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CH505+ of IgD- B cells
|
0.01 Percentage of B cells
Interval 0.0 to 0.01
|
1.98 Percentage of B cells
Interval 1.1 to 2.78
|
0.38 Percentage of B cells
Interval 0.28 to 0.83
|
1.34 Percentage of B cells
Interval 1.1 to 2.1
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CH505+ of IgG+ B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
5.98 Percentage of B cells
Interval 3.02 to 8.6
|
3.2 Percentage of B cells
Interval 1.65 to 4.76
|
5.11 Percentage of B cells
Interval 3.29 to 6.6
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
CH505+ of Plasmablasts
|
0.06 Percentage of B cells
Interval 0.02 to 0.09
|
0.08 Percentage of B cells
Interval 0.06 to 0.09
|
0.05 Percentage of B cells
Interval 0.02 to 0.07
|
0 Percentage of B cells
Interval 0.0 to 0.02
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
IgG+ B cells of total B cells
|
0.82 Percentage of B cells
Interval 0.61 to 0.87
|
1.41 Percentage of B cells
Interval 1.26 to 1.5
|
0.72 Percentage of B cells
Interval 0.57 to 0.94
|
1.26 Percentage of B cells
Interval 0.95 to 1.49
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 3rd Vaccination
Plasmablasts of B cells
|
1.22 Percentage of B cells
Interval 0.54 to 2.13
|
1.24 Percentage of B cells
Interval 1.2 to 1.29
|
0.84 Percentage of B cells
Interval 0.57 to 1.11
|
0.78 Percentage of B cells
Interval 0.45 to 1.21
|
—
|
PRIMARY outcome
Timeframe: Measured at month 13 (2 weeks after the 5th vaccination).Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the 5th vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
HIV-1 Env-specific B cells induced by vaccination were identified and characterized using fluorescently labeled recombinant Env proteins in the context of a flow cytometry panel to identify and characterize those B cell. Total B cells are identified using doublet exclusion, lymphocyte scatter profile, a viability dye to exclude dead cells, and are negative for lineage markers: CD3, CD56 and CD14; and positive for CD19 and CD20. B cells are further gated as IgD-, then IgG+, and IgA+.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CD4-BS specific of IgD- B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0.06 Percentage of B cells
Interval 0.05 to 0.07
|
0.06 Percentage of B cells
Interval 0.03 to 0.11
|
0.03 Percentage of B cells
Interval 0.03 to 0.04
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CH505+ of IgD- B cells
|
0 Percentage of B cells
Interval 0.0 to 0.01
|
0.89 Percentage of B cells
Interval 0.44 to 1.88
|
0.89 Percentage of B cells
Interval 0.49 to 1.15
|
0.8 Percentage of B cells
Interval 0.79 to 0.84
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CH505+ of Plasmablasts
|
0.05 Percentage of B cells
Interval 0.04 to 0.12
|
0.09 Percentage of B cells
Interval 0.05 to 0.12
|
0.12 Percentage of B cells
Interval 0.08 to 0.16
|
0.13 Percentage of B cells
Interval 0.08 to 0.19
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
IgG+ B cells of total B cells
|
3.24 Percentage of B cells
Interval 2.87 to 3.75
|
4.42 Percentage of B cells
Interval 4.21 to 6.47
|
3.18 Percentage of B cells
Interval 2.1 to 4.07
|
4.05 Percentage of B cells
Interval 3.7 to 5.27
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CD4-BS specific of B cells
|
0.01 Percentage of B cells
Interval 0.01 to 0.01
|
0.01 Percentage of B cells
Interval 0.01 to 0.02
|
0.01 Percentage of B cells
Interval 0.01 to 0.01
|
0.01 Percentage of B cells
Interval 0.01 to 0.01
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CD4-BS specific of IgA B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CD4-BS specific of IgG+ B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0.12 Percentage of B cells
Interval 0.11 to 0.12
|
0.12 Percentage of B cells
Interval 0.05 to 0.24
|
0.06 Percentage of B cells
Interval 0.04 to 0.07
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CD4-BS specific of Plasmablasts
|
0.04 Percentage of B cells
Interval 0.03 to 0.05
|
0.02 Percentage of B cells
Interval 0.0 to 0.05
|
0.05 Percentage of B cells
Interval 0.04 to 0.08
|
0.02 Percentage of B cells
Interval 0.01 to 0.13
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CH505+ of B cells
|
0.01 Percentage of B cells
Interval 0.01 to 0.01
|
0.13 Percentage of B cells
Interval 0.05 to 0.23
|
0.07 Percentage of B cells
Interval 0.04 to 0.11
|
0.09 Percentage of B cells
Interval 0.08 to 0.1
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CH505+ of IgA+ B cells
|
0 Percentage of B cells
Interval 0.0 to 0.04
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
0 Percentage of B cells
Interval 0.0 to 0.06
|
0 Percentage of B cells
Interval 0.0 to 0.03
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
CH505+ of IgG+ B cells
|
0 Percentage of B cells
Interval 0.0 to 0.0
|
2.17 Percentage of B cells
Interval 1.21 to 3.19
|
1.85 Percentage of B cells
Interval 1.32 to 2.78
|
1.7 Percentage of B cells
Interval 1.6 to 1.77
|
—
|
|
Quantification and Phenotypic Characterization of Peripheral B Cells Capable of Binding HIV-1 Env gp120 and the CD4 Binding Site, as Assessed by Flow Cytometry Two Weeks After the 5th Vaccinations
Plasmablasts of B cells
|
1.94 Percentage of B cells
Interval 1.3 to 2.37
|
1.87 Percentage of B cells
Interval 1.86 to 1.89
|
1.88 Percentage of B cells
Interval 1.49 to 2.27
|
1.47 Percentage of B cells
Interval 1.33 to 2.06
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants who received all relevant recommended EPI vaccine doses prior to month 13 for a given antigen. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against diphtheria, tetanus, pertussis, and rubella. The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations. A Hepatitis B antigen was tested as part of the PVMA panel, but did not pass lab-internal QC. The lab opted to test this antigen via ELISA and reported those calculated concentration data for analysis in lieu of the HepB PVMA data. A HepB standard was used in each assay for quality control.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus)
Pertussis
|
5.4 IU/mL
Interval 3.8 to 6.3
|
4.7 IU/mL
Interval 4.1 to 6.2
|
5.8 IU/mL
Interval 3.7 to 7.4
|
7.5 IU/mL
Interval 7.4 to 18.4
|
—
|
|
EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus)
Rubella
|
2.2 IU/mL
Interval 1.3 to 3.2
|
1.4 IU/mL
Interval 0.6 to 1.5
|
1.2 IU/mL
Interval 0.6 to 2.1
|
1.4 IU/mL
Interval 0.6 to 1.6
|
—
|
|
EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus)
Diptheria
|
0.5 IU/mL
Interval 0.4 to 1.0
|
0.5 IU/mL
Interval 0.4 to 0.9
|
0.3 IU/mL
Interval 0.3 to 0.5
|
0.8 IU/mL
Interval 0.4 to 0.9
|
—
|
|
EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus)
HepB
|
0.7 IU/mL
Interval 0.4 to 1.1
|
0.1 IU/mL
Interval 0.1 to 0.7
|
0.6 IU/mL
Interval 0.1 to 1.0
|
0.1 IU/mL
Interval 0.1 to 0.5
|
—
|
|
EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (Diptheria, HepB, Pertussis, Rubella, and Tetanus)
Tetanus
|
0.2 IU/mL
Interval 0.1 to 0.3
|
0.3 IU/mL
Interval 0.1 to 0.4
|
0.2 IU/mL
Interval 0.1 to 0.3
|
0.2 IU/mL
Interval 0.1 to 0.2
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants who received all relevant recommended EPI vaccine doses prior to month 13 for a given antigen. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
PVMA uses the same Luminex instrument and techniques as HVTN's standard Binding Antibody Multiplex Assay (BAMA) to assess serum samples for antibodies against Haemophilus influenzae type B (HiB) and respiratory syncytial virus (RSV). The assay is a reliable, high-throughput technique that requires minimal sample volume and measures multiple antibody concentrations.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (HiB and RSV)
HiB
|
0.2 µg/mL
Interval 0.1 to 0.4
|
0.3 µg/mL
Interval 0.0 to 0.8
|
0.1 µg/mL
Interval 0.0 to 0.3
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
|
EPI Vaccine-specific Antibody Responses, as Assessed by Pediatric Vaccine Multiplex Assay (PVMA) 2 Weeks After the 5th Vaccination (HiB and RSV)
RSV
|
0.2 µg/mL
Interval 0.0 to 6.2
|
0.4 µg/mL
Interval 0.1 to 4.7
|
4.9 µg/mL
Interval 0.7 to 6.2
|
2.7 µg/mL
Interval 1.7 to 4.4
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. All serum samples were assayed against Tier 1 and Tier 2 strains of virus by starting with a 1:10 dilution of serum to obtain a neutralizing antibody titer. ID50 (ID80) titers are defined as the serum dilution that reduces RLUs by 50% (or 80%) relative to the RLUs in virus control wells after subtraction of background.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH0505TF.gly4/GnT1- ID50
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH0505TF.gly4/GnT1- ID80
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH0505s.G458Y.N279K.N280D.6/GnT1 ID50
|
17.5 Titers
Interval 15.4 to 30.6
|
49.1 Titers
Interval 34.1 to 64.2
|
32.3 Titers
Interval 24.0 to 56.7
|
29 Titers
Interval 25.3 to 31.0
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH505.w4.3 ID80
|
5 Titers
Interval 5.0 to 5.0
|
86 Titers
Interval 22.9 to 115.0
|
733.9 Titers
Interval 214.2 to 1523.5
|
349.7 Titers
Interval 93.7 to 445.8
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH505TF ID80
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH0505s.G458Y.N279K.2/GnT1 ID50
|
11.9 Titers
Interval 5.0 to 19.8
|
5 Titers
Interval 5.0 to 31.7
|
35.4 Titers
Interval 19.7 to 64.1
|
28.8 Titers
Interval 26.0 to 36.5
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH0505s.G458Y.N279K.2/GnT1 ID80
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH0505s.G458Y.N279K.N280D.6/GnT1 ID80
|
—
|
24 Titers
Interval 24.0 to 24.0
|
12.9 Titers
Interval 12.5 to 15.6
|
—
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH505.w4.3 ID50
|
5 Titers
Interval 5.0 to 5.0
|
481.7 Titers
Interval 132.8 to 710.6
|
3961.6 Titers
Interval 1226.0 to 8180.1
|
1157 Titers
Interval 681.1 to 2971.8
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH505TF ID50
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH505TF.gly4.S365P/GnT1- ID50
|
—
|
13.1 Titers
Interval 13.1 to 13.1
|
38.8 Titers
Interval 34.3 to 43.4
|
—
|
—
|
|
Magnitude and Breadth of Serum Neutralization of Vaccine-matched Viral Isolates, and Viruses Engineered to Detect Precursors of CD4 Binding Site and V1V2 Antibodies 2 Weeks After the 5th Vaccination.
CH505TF.gly4.S365P/GnT1- ID80
|
—
|
—
|
16.1 Titers
Interval 16.1 to 16.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
Serum HIV-1-specific FcR responses (1:50 dilution) were measured using the standardized custom HIV-1 Luminex assay on a Luminex FLEXMAP 3D system. Readouts were background-subtracted mean fluorescence intensity (MFI), with background defined by plate-level controls. Net MFI was calculated as experimental minus reference antigen MFI, and values \<1 were set to 1. Post-enrollment samples were considered positive if they met all three criteria: (1) Net MFI ≥ antigen-specific cutoff (95th percentile of HVTN 115 Part A baseline at Day 0) and ≥ 100 above blank; (2) Net MFI \> 3 times the median baseline Net MFI; and (3) MFI \> 3 times the median baseline MFI. Response calls were based on the 1:50 dilution. Data were excluded if the blood draw was outside the allowable window, the participant was HIV positive, reference antigen MFI \> 5,000, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 CH505TF.6R.SOSIP.664.v4.1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 Con S gp140 CFI
|
0 Participants
|
3 Participants
|
14 Participants
|
4 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 gp70 CH505TF V1V2
|
0 Participants
|
3 Participants
|
13 Participants
|
5 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 gp41
|
7 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 1086C D7gp120
|
0 Participants
|
5 Participants
|
14 Participants
|
5 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 CH0505 CON D7gp120
|
0 Participants
|
4 Participants
|
14 Participants
|
5 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 Con 6 gp120/B
|
0 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 gp41
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 1086C D7gp120
|
0 Participants
|
5 Participants
|
14 Participants
|
5 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 CH0505 CON D7gp120
|
0 Participants
|
5 Participants
|
14 Participants
|
5 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 CH505TF.6R.SOSIP.664.v4.1
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 Con 6 gp120/B
|
0 Participants
|
5 Participants
|
12 Participants
|
5 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 Con S gp140 CFI
|
0 Participants
|
4 Participants
|
14 Participants
|
5 Participants
|
—
|
|
Response Rate of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 gp70 CH505TF V1V2
|
0 Participants
|
3 Participants
|
13 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
Serum HIV-1-specific FcR (dilution 1:50) responses were measured on a Luminex FLEXMAP 3D Instrument System using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 CH505TF.6R.SOSIP.664.v4.1
|
3 relative fluorescence units
Interval 1.0 to 33.8
|
18.8 relative fluorescence units
Interval 1.0 to 34.2
|
9.1 relative fluorescence units
Interval 4.3 to 28.6
|
14.8 relative fluorescence units
Interval 1.0 to 29.0
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 gp41
|
306 relative fluorescence units
Interval 125.5 to 693.8
|
94 relative fluorescence units
Interval 65.0 to 104.5
|
236.6 relative fluorescence units
Interval 64.8 to 565.2
|
338.2 relative fluorescence units
Interval 48.0 to 383.5
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 Con S gp140 CFI
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
204 relative fluorescence units
Interval 1.0 to 512.2
|
422.2 relative fluorescence units
Interval 265.4 to 2271.2
|
1692.8 relative fluorescence units
Interval 445.0 to 5837.5
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 gp41
|
94.8 relative fluorescence units
Interval 47.0 to 138.2
|
22.5 relative fluorescence units
Interval 17.2 to 26.5
|
45.8 relative fluorescence units
Interval 27.5 to 104.8
|
49.2 relative fluorescence units
Interval 48.0 to 55.0
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 1086C D7gp120
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
15724.8 relative fluorescence units
Interval 10368.5 to 26417.2
|
27590.1 relative fluorescence units
Interval 24425.3 to 33806.8
|
27235.2 relative fluorescence units
Interval 23596.2 to 33032.5
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 1086C D7gp120
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
3258.5 relative fluorescence units
Interval 929.5 to 5954.8
|
6725.4 relative fluorescence units
Interval 5105.7 to 10016.2
|
8750.2 relative fluorescence units
Interval 5556.5 to 10306.2
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 CH0505 CON D7gp120
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
859.2 relative fluorescence units
Interval 157.2 to 1342.2
|
1539.4 relative fluorescence units
Interval 673.2 to 6839.2
|
1922 relative fluorescence units
Interval 1291.0 to 4116.0
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 CH505TF.6R.SOSIP.664.v4.1
|
1 relative fluorescence units
Interval 1.0 to 7.5
|
8.8 relative fluorescence units
Interval 7.5 to 11.0
|
1.6 relative fluorescence units
Interval 1.0 to 3.8
|
3.8 relative fluorescence units
Interval 1.0 to 5.3
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 Con 6 gp120/B
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
15.5 relative fluorescence units
Interval 15.3 to 55.5
|
326.1 relative fluorescence units
Interval 31.5 to 3721.7
|
59 relative fluorescence units
Interval 47.8 to 788.2
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcGRIIIa F158 gp70 CH505TF V1V2
|
1 relative fluorescence units
Interval 1.0 to 7.0
|
1323.8 relative fluorescence units
Interval 111.2 to 9646.0
|
2486.1 relative fluorescence units
Interval 1038.8 to 8161.1
|
6085.2 relative fluorescence units
Interval 4409.8 to 28614.2
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 CH0505 CON D7gp120
|
1 relative fluorescence units
Interval 1.0 to 1.0
|
5262 relative fluorescence units
Interval 1516.8 to 9341.8
|
12016.9 relative fluorescence units
Interval 5570.3 to 25277.0
|
11767.5 relative fluorescence units
Interval 10037.0 to 16316.2
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 Con 6 gp120/B
|
1 relative fluorescence units
Interval 1.0 to 4.5
|
377.5 relative fluorescence units
Interval 273.0 to 647.2
|
4278.2 relative fluorescence units
Interval 522.8 to 13886.9
|
860.5 relative fluorescence units
Interval 644.5 to 5295.8
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 Con S gp140 CFI
|
1 relative fluorescence units
Interval 1.0 to 4.0
|
4364.5 relative fluorescence units
Interval 227.5 to 5668.5
|
7722.6 relative fluorescence units
Interval 4547.6 to 19637.6
|
12558 relative fluorescence units
Interval 7184.0 to 25031.0
|
—
|
|
Magnitude of Vaccine-elicited Serum Binding Antibodies to FcR Proteins, as Assessed by BAMA 2 Weeks After the 5th Vaccination
FcgRIIa H131 gp70 CH505TF V1V2
|
1 relative fluorescence units
Interval 1.0 to 2.5
|
5403.8 relative fluorescence units
Interval 311.2 to 22245.2
|
10442.4 relative fluorescence units
Interval 4374.9 to 22312.4
|
16390.8 relative fluorescence units
Interval 15740.5 to 44073.5
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells. There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to %GzB activity. A positive response is defined as ≥ 8% GzB activity.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination
|
0 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
The qualified GranToxiLux Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC-GTL) assay was performed to measure ADCC-mediated antibody responses. ADCC is quantified as net percent granzyme B activity, which is the percent of target cells positive for GTL (an indicator of granzyme B uptake) minus the percent of target cells positive for GTL when incubated with effector cells in the absence of a source of antibodies. Flow cytometry is used to quantify the frequency of granzyme B positive cells.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry Assay 2 Weeks After the 5th Vaccination
|
0 Peak Net % Granzyme B Activity
Interval 0.0 to 0.7
|
24.3 Peak Net % Granzyme B Activity
Interval 21.8 to 24.5
|
8.1 Peak Net % Granzyme B Activity
Interval 5.8 to 9.7
|
6.8 Peak Net % Granzyme B Activity
Interval 4.5 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 \* (RLU of target and effector well- RLU of test well)/(RLU of target and effector well). There is no baseline subtraction applied to the responses, and a fixed positivity threshold is applied to percent killing or loss of luciferase activity. A positive response is defined as percent specific killing ≥ 15%.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Response Rate of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination
|
2 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
ADCC-mediated antibody responses were measured by luciferase ADCC assay using HIV CH0505s.LucR.T2A.ecto/293T/17 Infectious Molecular Clone (IMC)-infected target cells. Luminescence intensity reflects the number of intact target cells remaining after incubation with effector cells in the presence or absence of ADCC-mediating serum antibodies. Lower luminescence corresponds to fewer intact target cells. The outcome measure was calculated as the percent specific change in luciferase activity, defined as: percent specific change in luciferase activity = 100 \* (RLU of target and effector well- RLU of test well)/(RLU of target and effector well).
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Magnitude of Serum Antibody-dependent Cellular Cytotoxicity (ADCC) to HIV CH0505s.LucR.T2A.Ecto/293T/17, as Assessed by Luciferase Assay 2 Weeks After the 5th Vaccination
|
7.9 Peak % loss luciferase activity
Interval 4.9 to 9.0
|
9 Peak % loss luciferase activity
Interval 7.1 to 12.6
|
13.6 Peak % loss luciferase activity
Interval 9.5 to 19.9
|
18.4 Peak % loss luciferase activity
Interval 14.0 to 24.7
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background. Positivity calls were based on two criteria: 1) Average ADCP score ≥ antigen specific cutoff values (max(95th percentile of HVTN 115 baseline ADCP score, 1)) and 2) Average ADCP score \> 3x antigen specific median HVTN 115 baseline average ADCP score.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Response Rate of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination
|
7 Participants
|
5 Participants
|
14 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured at month 13, 2 weeks after the 5th vaccination.Population: "Overall Number of Participants Analyzed" includes those with samples collected at 2 weeks after the 5th vaccination, who were HIV-uninfected and received the last vaccination with specimens. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. Groups 3 and 5 (20 mcg CH505TF gp120 and 2.5 mcg GLA-SE) who received the same vaccine regimen were pooled in the analyses.
ADCP assay is a qualified assay employing flow cytrometric-based technology that measures the ability of antibodies to mediate phagocytosis. A phagocytic score is determined based on the ratio of experimental sample to PBS control. Mean phagocytosis score is defined as: (% bead positive for participant x MFI bead positive for participant) / (% bead positive for PBS only control x MFI bead positive for PBS only control). Higher phagocytosis score values indicate a greater level of antibody-mediated phagocytic activity relative to the PBS control, while values closer to 1 indicate minimal activity above background.
Outcome measures
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=9 Participants
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=14 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 Participants
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Magnitude of Serum Antibody-dependent Cellular Phagocytosis (ADCP) to CH505TF D7gp120.Avi/293F, as Assessed by Flow Cytometry 2 Weeks After the 5th Vaccination
|
2.1 Mean phagocytosis score
Interval 1.5 to 2.5
|
14.7 Mean phagocytosis score
Interval 4.3 to 16.6
|
11.4 Mean phagocytosis score
Interval 9.1 to 13.9
|
10.9 Mean phagocytosis score
Interval 10.5 to 11.6
|
—
|
Adverse Events
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 participants at risk
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 participants at risk
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 participants at risk
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 participants at risk
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 participants at risk
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Fungal skin infection
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Ophthalmia neonatorum
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
Other adverse events
| Measure |
Groups 2, 4, 6, 8: Placebo at w(0,8,16,32,54)
n=10 participants at risk
Placebo (Sodium Chloride, 0.9% USP) administered as a 0.25 mL (Group 2) or 0.5 mL (Groups 4, 6, and 8) IM injection at Weeks 0, 8, 16, 32, and 54
|
Part A, Group 1: 20 mcg CH505TF gp120, 2.5 mcg GLA-SE at w(0,8,16,32,54)
n=5 participants at risk
20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, administered as a 0.25 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part B, Group 3: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=2 participants at risk
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 5: 20 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=16 participants at risk
20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
Part C, Group 7: 5 mcg CH505TF gp120, 5 mcg GLA-SE at w(0,8,16,32,54)
n=5 participants at risk
5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Eye disorders
Eye discharge
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Diarrhoea
|
70.0%
7/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
12.5%
2/16 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Teething
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Gastrointestinal disorders
Vomiting (Solicited)
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Hypothermia
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Inflammation
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Injection site erythema (Solicited)
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Injection site pain (Solicited)
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
25.0%
4/16 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Injection site swelling
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
General disorders
Pyrexia (Solicited)
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
60.0%
3/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Body tinea
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Conjunctivitis
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Ear infection
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Gastroenteritis
|
30.0%
3/10 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
18.8%
3/16 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Impetigo
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Injection site abscess
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Lower respiratory tract infection
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
25.0%
4/16 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Otitis media
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
60.0%
3/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Infections and infestations
Upper respiratory tract infection
|
60.0%
6/10 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
80.0%
4/5 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
100.0%
2/2 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
25.0%
4/16 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
60.0%
3/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Investigations
Haemoglobin decreased
|
90.0%
9/10 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
60.0%
3/5 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
100.0%
2/2 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
75.0%
12/16 • Number of events 18 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
80.0%
4/5 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Investigations
Neutrophil count decreased
|
60.0%
6/10 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
25.0%
4/16 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Metabolism and nutrition disorders
Decreased appetite (Solicited)
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
31.2%
5/16 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Metabolism and nutrition disorders
Underweight
|
40.0%
4/10 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
18.8%
3/16 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Nervous system disorders
Somnolence (Solicited)
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
18.8%
3/16 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
12.5%
2/16 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
30.0%
3/10 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
18.8%
3/16 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
25.0%
4/16 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/16 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
40.0%
2/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
50.0%
1/2 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
18.8%
3/16 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Rash (Solicited)
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
18.8%
3/16 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
20.0%
2/10 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
6.2%
1/16 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each infant participant (from the infant's study enrollment until his or her study completion or discontinuation), up to 25 months. Reactogenicity events (solicited AEs) were collected through 7 full days after each vaccination. Adverse Event was not collected for Mothers.
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 2066675812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place