Trial Outcomes & Findings for Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants (NCT NCT02256631)
NCT ID: NCT02256631
Last Updated: 2023-02-08
Results Overview
The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
83 participants
Primary outcome timeframe
From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)
Results posted on
2023-02-08
Participant Flow
83 mother-infant pairs were enrolled in the study. Since the mothers did not receive any treatment on study and were taken off study immediately after enrollment, the number of participants shown in all tables is the number of infants (83). Participants were enrolled from June 2015 to February 2020, at 14 medical clinics in the United States, Puerto Rico, South Africa and Zimbabwe.
Dose groups enrolled sequentially. There was no randomization.
Participant milestones
| Measure |
Dose Group 1
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
13
|
10
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
13
|
6
|
10
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
4
|
1
|
5
|
4
|
Reasons for withdrawal
| Measure |
Dose Group 1
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
2
|
0
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Unable to get to clinic
|
0
|
2
|
0
|
1
|
0
|
1
|
2
|
Baseline Characteristics
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Baseline characteristics by cohort
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
n=11 Participants
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age at first dose
|
2 days
n=5 Participants
|
2 days
n=7 Participants
|
2 days
n=5 Participants
|
2 days
n=4 Participants
|
2 days
n=21 Participants
|
1 days
n=8 Participants
|
4 days
n=8 Participants
|
2 days
n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
70 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
68 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
2 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
0 participants
n=21 Participants
|
11 participants
n=8 Participants
|
0 participants
n=8 Participants
|
37 participants
n=24 Participants
|
|
Region of Enrollment
South Africa
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
3 participants
n=4 Participants
|
5 participants
n=21 Participants
|
0 participants
n=8 Participants
|
7 participants
n=8 Participants
|
31 participants
n=24 Participants
|
|
Region of Enrollment
Zimbabwe
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
13 participants
n=24 Participants
|
|
Birth Weight
|
3045 grams
n=5 Participants
|
3160 grams
n=7 Participants
|
2860 grams
n=5 Participants
|
2865 grams
n=4 Participants
|
2920 grams
n=21 Participants
|
2810 grams
n=8 Participants
|
3235 grams
n=8 Participants
|
2920 grams
n=24 Participants
|
PRIMARY outcome
Timeframe: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)Population: All infant study participants.
The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
n=11 Participants
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Died
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
PRIMARY outcome
Timeframe: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)Population: All infant study participants.
The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
n=11 Participants
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE)
|
31 percentage of participants
Interval 11.0 to 57.0
|
14 percentage of participants
Interval 3.0 to 39.0
|
31 percentage of participants
Interval 11.0 to 57.0
|
10 percentage of participants
Interval 1.0 to 39.0
|
27 percentage of participants
Interval 8.0 to 56.0
|
36 percentage of participants
Interval 14.0 to 65.0
|
9 percentage of participants
Interval 0.0 to 36.0
|
PRIMARY outcome
Timeframe: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)Population: All infant study participants.
The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
n=11 Participants
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE)
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
PRIMARY outcome
Timeframe: From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.)Population: All infant study participants.
The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
n=11 Participants
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Diagnosed With HIV Infection
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
PRIMARY outcome
Timeframe: Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.Population: Infants who received the correct dose and were evaluated for PK at the designated timepoints.
The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized.
Outcome measures
| Measure |
Dose Group 1
n=12 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=13 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=9 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=9 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4
|
2672 mcg*d/mL
Interval 1700.0 to 3661.0
|
4435 mcg*d/mL
Interval 3544.0 to 6374.0
|
6654 mcg*d/mL
Interval 4040.0 to 8120.0
|
9825 mcg*d/mL
Interval 5594.0 to 12487.0
|
8639 mcg*d/mL
Interval 6159.0 to 12879.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.Population: Participants who received the correct dose and were evaluated for PK at the designated timepoints.
The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized.
Outcome measures
| Measure |
Dose Group 1
n=10 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=10 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5
|
5358 mcg*d/mL
Interval 4180.0 to 8835.0
|
4462 mcg*d/mL
Interval 2840.0 to 6044.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84.Population: Infants who received the correct dose and were evaluated for PK at the designated timepoints.
The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4.
Outcome measures
| Measure |
Dose Group 1
n=12 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=13 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=9 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=9 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4
|
39.19 mcg/mL
Interval 16.71 to 76.56
|
75.25 mcg/mL
Interval 47.61 to 122.59
|
124.24 mcg/mL
Interval 62.16 to 180.22
|
44.64 mcg/mL
Interval 30.83 to 64.22
|
49.60 mcg/mL
Interval 23.96 to 62.13
|
—
|
—
|
PRIMARY outcome
Timeframe: Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84.Population: Participants who received the correct dose and were evaluated for PK at the designated timepoints.
The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days).
Outcome measures
| Measure |
Dose Group 1
n=9 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=8 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5
|
15.81 mcg/mL
Interval 11.9 to 21.42
|
19.07 mcg/mL
Interval 9.48 to 36.63
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
Outcome measures
| Measure |
Dose Group 1
n=11 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=11 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Died After Last Immunization for Dose Group 5
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4
|
23 percentage of participants
Interval 7.0 to 49.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 21.0
|
20 percentage of participants
Interval 4.0 to 51.0
|
18 percentage of participants
Interval 3.0 to 47.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
Outcome measures
| Measure |
Dose Group 1
n=11 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=11 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5
|
18 percentage of participants
Interval 3.0 to 47.0
|
27 percentage of participants
Interval 8.0 to 56.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=10 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
Outcome measures
| Measure |
Dose Group 1
n=11 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=11 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=14 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=10 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=11 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=11 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
0 percentage of participants
Interval 0.0 to 21.0
|
0 percentage of participants
Interval 0.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5).Population: All infants enrolled in these Dose Groups.
The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated.
Outcome measures
| Measure |
Dose Group 1
n=11 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=11 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5
|
0 percentage of participants
Interval 0.0 to 24.0
|
0 percentage of participants
Interval 0.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At weeks 24 and 48.Population: Infant study participants with samples collected and tested.
The Overall Number of Participants Analyzed represents infants with samples collected and tested. The number of infants who developed anti antibodies to the study products are summarized. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies.
Outcome measures
| Measure |
Dose Group 1
n=13 Participants
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 2
n=12 Participants
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 3
n=13 Participants
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 1
n=8 Participants
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 4, Cohort 2
n=10 Participants
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
VRC01LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 1
n=8 Participants
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
Dose Group 5, Cohort 2
n=6 Participants
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
VRC07-523LS: Administered by subcutaneous injection in the thigh
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Anti-VRC Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Group 1
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Dose Group 2
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Dose Group 3
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Dose Group 4, Cohort 1
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Dose Group 4, Cohort 2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose Group 5, Cohort 1
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose Group 5, Cohort 2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Group 1
n=13 participants at risk
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
|
Dose Group 2
n=14 participants at risk
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
|
Dose Group 3
n=13 participants at risk
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
|
Dose Group 4, Cohort 1
n=10 participants at risk
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
|
Dose Group 4, Cohort 2
n=11 participants at risk
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
|
Dose Group 5, Cohort 1
n=11 participants at risk
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
|
Dose Group 5, Cohort 2
n=11 participants at risk
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
ABO haemolytic disease of newborn
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchiolitis
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia bacterial
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
Other adverse events
| Measure |
Dose Group 1
n=13 participants at risk
Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth.
|
Dose Group 2
n=14 participants at risk
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
|
Dose Group 3
n=13 participants at risk
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
|
Dose Group 4, Cohort 1
n=10 participants at risk
Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
|
Dose Group 4, Cohort 2
n=11 participants at risk
Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding.
|
Dose Group 5, Cohort 1
n=11 participants at risk
Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater.
|
Dose Group 5, Cohort 2
n=11 participants at risk
Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Blood and lymphatic system disorders
Neutropenia neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Cardiac disorders
Neonatal tachycardia
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Congenital pigmentation disorder
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Congenital umbilical hernia
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
38.5%
5/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
36.4%
4/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Naevus flammeus
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Pulmonary artery stenosis congenital
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Sickle cell trait
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Congenital, familial and genetic disorders
Strabismus congenital
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Eye discharge
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
28.6%
4/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Ocular hyperaemia
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Coating in mouth
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Constipation neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
28.6%
4/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Diarrhoea neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Eructation
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Flatulence
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Infantile colic
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Infantile spitting up
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Infantile vomiting
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Umbilical hernia
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Crying
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Drug withdrawal syndrome neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Fever neonatal
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Generalised oedema
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Peripheral swelling
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Pyrexia
|
46.2%
6/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
General disorders
Withdrawal syndrome
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Body tinea
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Bronchiolitis
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Candida nappy rash
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Cellulitis
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Conjunctivitis
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Gastrointestinal viral infection
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Neonatal candida infection
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Ophthalmia neonatorum
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Oral candidiasis
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
30.0%
3/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
27.3%
3/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Otitis media
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Otitis media acute
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pharyngitis
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Pustule
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Septic rash
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Septic shock
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Varicella
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Viral infection
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Eyelid abrasion
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
20.0%
2/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
40.0%
4/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
36.4%
4/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
27.3%
3/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood albumin decreased
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood bicarbonate
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood bicarbonate decreased
|
30.8%
4/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
35.7%
5/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
27.3%
3/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood bilirubin increased
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
30.0%
3/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood calcium increased
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
28.6%
4/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
20.0%
2/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood creatinine increased
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood glucose decreased
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood potassium increased
|
38.5%
5/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
42.9%
6/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
20.0%
2/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
27.3%
3/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Blood sodium decreased
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
35.7%
5/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Breath sounds abnormal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Capillary nail refill test abnormal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Cardiac murmur
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Faecal volume decreased
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Haemoglobin decreased
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
84.6%
11/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
70.0%
7/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
100.0%
11/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
54.5%
6/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
54.5%
6/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Liver palpable
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Neutrophil count decreased
|
30.8%
4/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
46.2%
6/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
40.0%
4/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
63.6%
7/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
27.3%
3/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Urine output decreased
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Investigations
Weight decreased
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypoglycaemia neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Hypophagia
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Musculoskeletal and connective tissue disorders
Growth failure
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Agitation neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Fontanelle bulging
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Infant irritability
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Nervous system disorders
Tremor neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Caput succedaneum
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
20.0%
2/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal disorder
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Poor weight gain neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Pregnancy, puerperium and perinatal conditions
Weight decrease neonatal
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
36.4%
4/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
36.4%
4/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Psychiatric disorders
Selective eating disorder
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Renal and urinary disorders
Polyuria
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Genital macule
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Genital swelling
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Penile rash
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Perineal erythema
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Scrotal dermatitis
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
61.5%
8/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
69.2%
9/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
27.3%
3/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Grunting
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Irregular breathing
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
53.8%
7/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
57.1%
8/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
46.2%
6/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
27.3%
3/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
30.8%
4/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Use of accessory respiratory muscles
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
14.3%
2/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Erythema toxicum neonatorum
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
20.0%
2/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
20.0%
2/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
4/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
46.2%
6/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash neonatal
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
21.4%
3/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
15.4%
2/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
36.4%
4/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
18.2%
2/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
23.1%
3/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Transient neonatal pustular melanosis
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
10.0%
1/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Umbilical haemorrhage
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.7%
1/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
9.1%
1/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
|
Vascular disorders
Pallor
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
7.1%
1/14 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/13 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/10 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
0.00%
0/11 • From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
|
Additional Information
Melissa Allen, Director, IMPAACT Operations Center
Family Health International (FHI 360)
Phone: (919) 405-1429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place