Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention (NCT NCT02315703)
NCT ID: NCT02315703
Last Updated: 2025-02-04
Results Overview
Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
393 participants
Primary outcome timeframe
Up to Week 49 (7 days post any dose)
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
|
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Main Study (From Week 0 up to Week 96)
STARTED
|
50
|
49
|
49
|
48
|
49
|
49
|
50
|
49
|
|
Main Study (From Week 0 up to Week 96)
COMPLETED
|
44
|
39
|
44
|
39
|
41
|
43
|
37
|
42
|
|
Main Study (From Week 0 up to Week 96)
NOT COMPLETED
|
6
|
10
|
5
|
9
|
8
|
6
|
13
|
7
|
|
LTE (After Week 96 up to Week 336)
STARTED
|
31
|
32
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE (After Week 96 up to Week 336)
COMPLETED
|
29
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE (After Week 96 up to Week 336)
NOT COMPLETED
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
|
Group 8: Placebo/ Placebo
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Main Study (From Week 0 up to Week 96)
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Main Study (From Week 0 up to Week 96)
Lost to Follow-up
|
1
|
5
|
3
|
3
|
2
|
1
|
2
|
2
|
|
Main Study (From Week 0 up to Week 96)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Main Study (From Week 0 up to Week 96)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Main Study (From Week 0 up to Week 96)
Withdrawal by Subject
|
1
|
3
|
0
|
3
|
4
|
1
|
1
|
2
|
|
Main Study (From Week 0 up to Week 96)
Other
|
4
|
2
|
2
|
2
|
1
|
2
|
8
|
2
|
|
LTE (After Week 96 up to Week 336)
Lost to Follow-up
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE (After Week 96 up to Week 336)
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE (After Week 96 up to Week 336)
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
Baseline characteristics by cohort
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=50 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=48 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=50 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
|
Group 8: Placebo/ Placebo
n=49 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 7.49 • n=7 Participants
|
31.1 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 7.67 • n=4 Participants
|
30.3 years
STANDARD_DEVIATION 7.61 • n=21 Participants
|
29.2 years
STANDARD_DEVIATION 8.73 • n=8 Participants
|
30.3 years
STANDARD_DEVIATION 7.65 • n=8 Participants
|
29 years
STANDARD_DEVIATION 8.06 • n=24 Participants
|
29.9 years
STANDARD_DEVIATION 7.86 • n=42 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
181 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
29 Participants
n=24 Participants
|
212 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
43 Participants
n=24 Participants
|
357 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
64 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
219 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
104 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
RWANDA
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
58 Participants
n=42 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
56 Participants
n=42 Participants
|
|
Region of Enrollment
THAILAND
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
58 Participants
n=42 Participants
|
|
Region of Enrollment
UGANDA
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
71 Participants
n=42 Participants
|
|
Region of Enrollment
UNITED STATES
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
150 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Week 49 (7 days post any dose)Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=50 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=48 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=50 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=49 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination
|
88.0 percentage of participants
|
83.7 percentage of participants
|
75.5 percentage of participants
|
77.1 percentage of participants
|
77.6 percentage of participants
|
77.6 percentage of participants
|
70.0 percentage of participants
|
57.1 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 49 (7 days post any dose)Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after vaccination.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=50 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=48 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=50 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=49 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination
|
88.0 percentage of participants
|
85.7 percentage of participants
|
73.5 percentage of participants
|
75.0 percentage of participants
|
87.8 percentage of participants
|
73.5 percentage of participants
|
62.0 percentage of participants
|
59.2 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 52 (28 days post vaccination)Population: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=50 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=48 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=50 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=49 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Adverse Events Post Vaccination
|
80.0 percentage of participants
|
73.5 percentage of participants
|
85.7 percentage of participants
|
87.5 percentage of participants
|
69.4 percentage of participants
|
83.7 percentage of participants
|
86.0 percentage of participants
|
77.6 percentage of participants
|
PRIMARY outcome
Timeframe: Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, 4, 5, 6, 7, and 8). Other adverse events (AEs) were reported for the main study period up to Week 96 for all the groupsPopulation: The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=50 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=48 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=49 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=50 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=49 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Post Vaccination
|
5 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Week 28Population: Per protocol immunogenicity (PPI) analysis set: participants who received at least first 3 vaccines as scheduled, had at least 1 post-vaccination immunogenicity blood draw and not diagnosed with HIV. N(number of participants analyzed): participants who were evaluable for this OM. n(number analyzed): participants evaluable for specified categories.
The Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline greater than or equal to (\>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, and 156.25 endotoxin units per milliliter (EU/mL) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), and Clade C (C97ZA.012) respectively.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=49 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=41 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=46 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=42 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=46 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28
Clade A (92UG037.1)
|
100.0 percentage of responders
Interval 92.6 to 100.0
|
97.6 percentage of responders
Interval 87.14 to 99.94
|
97.8 percentage of responders
Interval 88.47 to 99.94
|
95.5 percentage of responders
Interval 84.53 to 99.44
|
97.7 percentage of responders
Interval 87.71 to 99.94
|
97.6 percentage of responders
Interval 87.43 to 99.94
|
95.5 percentage of responders
Interval 84.53 to 99.44
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
|
Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28
Clade B (1990a)
|
100.0 percentage of responders
Interval 92.6 to 100.0
|
100.0 percentage of responders
Interval 91.4 to 100.0
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
100.0 percentage of responders
Interval 91.96 to 100.0
|
6.5 percentage of responders
Interval 1.37 to 17.9
|
|
Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28
Clade C (Con C)
|
100.0 percentage of responders
Interval 92.45 to 100.0
|
100.0 percentage of responders
Interval 91.4 to 100.0
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
95.5 percentage of responders
Interval 84.53 to 99.44
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
6.5 percentage of responders
Interval 1.37 to 17.9
|
|
Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28
Clade C (C97ZA.012)
|
100 percentage of responders
Interval 92.6 to 100.0
|
100 percentage of responders
Interval 91.4 to 100.0
|
100 percentage of responders
Interval 92.29 to 100.0
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
100 percentage of responders
Interval 91.59 to 100.0
|
100 percentage of responders
Interval 91.59 to 100.0
|
100 percentage of responders
Interval 91.96 to 100.0
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
SECONDARY outcome
Timeframe: Week 28, 52 and 96Population: PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Vaccine-induced binding antibody IgG1, IgG2, IgG3 and IgG4 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3, 28.7, 12.4, and 13.2 for IgG1, IgG2, IgG3 and IgG4 respectively. Samples taken after Week 48 (W48) from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=47 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=41 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=46 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=45 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=42 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=40 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=45 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG2 at Week 28
|
0 percentage of responders
Interval 0.0 to 7.55
|
0 percentage of responders
Interval 0.0 to 8.6
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
2.2 percentage of responders
Interval 0.06 to 11.77
|
2.4 percentage of responders
Interval 0.06 to 12.57
|
0 percentage of responders
Interval 0.0 to 8.81
|
2.3 percentage of responders
Interval 0.06 to 12.02
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG1 at Week 28
|
78.7 percentage of responders
Interval 64.34 to 89.3
|
80.5 percentage of responders
Interval 65.13 to 91.18
|
50.0 percentage of responders
Interval 34.9 to 65.1
|
82.2 percentage of responders
Interval 67.95 to 92.0
|
61.9 percentage of responders
Interval 45.64 to 76.43
|
67.5 percentage of responders
Interval 50.87 to 81.43
|
81.8 percentage of responders
Interval 67.29 to 91.81
|
0.0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG1 at Week 52
|
81.8 percentage of responders
Interval 67.29 to 91.81
|
94.7 percentage of responders
Interval 82.25 to 99.36
|
59.5 percentage of responders
Interval 43.28 to 74.37
|
82.9 percentage of responders
Interval 67.94 to 92.85
|
71.8 percentage of responders
Interval 55.13 to 85.0
|
72.5 percentage of responders
Interval 56.11 to 85.4
|
89.5 percentage of responders
Interval 75.2 to 97.06
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG1 at Week 96
|
36.6 percentage of responders
Interval 22.12 to 53.06
|
26.3 percentage of responders
Interval 13.4 to 43.1
|
4.3 percentage of responders
Interval 0.11 to 21.95
|
38.1 percentage of responders
Interval 18.11 to 61.56
|
16.7 percentage of responders
Interval 4.74 to 37.38
|
0 percentage of responders
Interval 0.0 to 13.72
|
50.0 percentage of responders
Interval 29.12 to 70.88
|
—
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG2 at Week 52
|
2.3 percentage of responders
Interval 0.06 to 12.29
|
0 percentage of responders
Interval 0.0 to 9.25
|
0 percentage of responders
Interval 0.0 to 8.41
|
4.9 percentage of responders
Interval 0.6 to 16.53
|
7.7 percentage of responders
Interval 1.62 to 20.87
|
0 percentage of responders
Interval 0.0 to 8.81
|
7.9 percentage of responders
Interval 1.66 to 21.38
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG3 at Week 28
|
44.7 percentage of responders
Interval 30.17 to 59.88
|
29.3 percentage of responders
Interval 16.13 to 45.54
|
10.9 percentage of responders
Interval 3.62 to 23.57
|
47.7 percentage of responders
Interval 32.46 to 63.31
|
29.3 percentage of responders
Interval 16.13 to 45.54
|
20.5 percentage of responders
Interval 9.3 to 36.46
|
25.0 percentage of responders
Interval 13.19 to 40.34
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG3 at Week 52
|
43.2 percentage of responders
Interval 28.35 to 58.97
|
42.1 percentage of responders
Interval 26.31 to 59.18
|
7.1 percentage of responders
Interval 1.5 to 19.48
|
51.2 percentage of responders
Interval 35.13 to 67.12
|
35.9 percentage of responders
Interval 21.2 to 52.82
|
15.4 percentage of responders
Interval 5.86 to 30.53
|
43.2 percentage of responders
Interval 27.1 to 60.51
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG3 at Week 96
|
12.2 percentage of responders
Interval 4.08 to 26.2
|
8.3 percentage of responders
Interval 1.75 to 22.47
|
4.0 percentage of responders
Interval 0.1 to 20.35
|
4.5 percentage of responders
Interval 0.12 to 22.84
|
13.6 percentage of responders
Interval 2.91 to 34.91
|
8.3 percentage of responders
Interval 1.03 to 27.0
|
16.7 percentage of responders
Interval 4.74 to 37.38
|
—
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG4 at Week 28
|
0 percentage of responders
Interval 0.0 to 7.55
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 7.87
|
4.4 percentage of responders
Interval 0.54 to 15.15
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.04
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
Clade C (C97ZA.012) IgG4 at Week 52
|
2.3 percentage of responders
Interval 0.06 to 12.02
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
0 percentage of responders
Interval 0.0 to 8.41
|
7.3 percentage of responders
Interval 1.54 to 19.92
|
0 percentage of responders
Interval 0.0 to 9.03
|
0 percentage of responders
Interval 0.0 to 8.81
|
5.3 percentage of responders
Interval 0.64 to 17.75
|
0 percentage of responders
Interval 0.0 to 8.81
|
SECONDARY outcome
Timeframe: Week 28, 52 and 96Population: PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQ for this assay is a 50 percent (%) inhibitory concentration (IC50) of 20 (fold-dilution). The lower limits of quantification (LLOQs) for this assay were 625 and 78.125 EU/mL for Clade C (Con C) and Mos1 respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=49 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=41 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=46 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=42 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=46 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
Consensus C (Con C) at Week 28
|
100 percentage of responders
Interval 92.45 to 100.0
|
100.0 percentage of responders
Interval 91.4 to 100.0
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
95.5 percentage of responders
Interval 84.53 to 99.44
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
6.5 percentage of responders
Interval 1.37 to 17.9
|
|
Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
Consensus C (Con C) at Week 52
|
100.0 percentage of responders
Interval 92.13 to 100.0
|
100.0 percentage of responders
Interval 91.19 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
95.1 percentage of responders
Interval 83.47 to 99.4
|
100.0 percentage of responders
Interval 91.19 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
2.4 percentage of responders
Interval 0.06 to 12.57
|
|
Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
Mos1 at Week 28
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
100.0 percentage of responders
Interval 91.19 to 100.0
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
97.7 percentage of responders
Interval 87.71 to 99.94
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
4.3 percentage of responders
Interval 0.53 to 14.84
|
|
Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
Mos1 at Week 52
|
100.0 percentage of responders
Interval 91.96 to 100.0
|
100.0 percentage of responders
Interval 91.19 to 100.0
|
100.0 percentage of responders
Interval 91.4 to 100.0
|
97.5 percentage of responders
Interval 86.84 to 99.94
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
100.0 percentage of responders
Interval 90.26 to 100.0
|
0 percentage of responders
Interval 0.0 to 8.41
|
|
Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens
Mos1 at Week 96
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
100.0 percentage of responders
Interval 91.59 to 100.0
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
0 percentage of responders
Interval 0.0 to 8.81
|
SECONDARY outcome
Timeframe: Week 16, 26, 28, 52, 78, and 96Population: PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value \> limit of detection (LOD) if baseline \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category of Clade A, B, C and Mos 1.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=47 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=41 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=46 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=45 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=42 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=42 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=46 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Mos1 at Week 28
|
95.7 percentage of responders
Interval 85.46 to 99.48
|
87.8 percentage of responders
Interval 73.8 to 95.92
|
84.8 percentage of responders
Interval 71.13 to 93.66
|
93.3 percentage of responders
Interval 81.73 to 98.6
|
92.9 percentage of responders
Interval 80.52 to 98.5
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
86.4 percentage of responders
Interval 72.65 to 94.83
|
0 percentage of responders
Interval 0.0 to 7.71
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade A (92UG037.1) at Week 16
|
20.0 percentage of responders
Interval 2.52 to 55.61
|
20.0 percentage of responders
Interval 2.52 to 55.61
|
10.0 percentage of responders
Interval 0.25 to 44.5
|
66.7 percentage of responders
Interval 29.93 to 92.51
|
0 percentage of responders
Interval 0.0 to 36.94
|
0 percentage of responders
Interval 0.0 to 45.93
|
0 percentage of responders
Interval 0.0 to 33.63
|
0 percentage of responders
Interval 0.0 to 36.94
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade A (92UG037.1) at Week 28
|
36.2 percentage of responders
Interval 22.67 to 51.48
|
29.3 percentage of responders
Interval 16.13 to 45.54
|
6.5 percentage of responders
Interval 1.37 to 17.9
|
46.7 percentage of responders
Interval 31.66 to 62.13
|
21.4 percentage of responders
Interval 10.3 to 36.81
|
22.5 percentage of responders
Interval 10.84 to 38.45
|
9.1 percentage of responders
Interval 2.53 to 21.67
|
0 percentage of responders
Interval 0.0 to 7.71
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade B (1990a) at Week 16
|
50.0 percentage of responders
Interval 18.71 to 81.29
|
50.0 percentage of responders
Interval 18.71 to 81.29
|
30.0 percentage of responders
Interval 6.67 to 65.25
|
66.7 percentage of responders
Interval 29.93 to 92.51
|
37.5 percentage of responders
Interval 8.52 to 75.51
|
16.7 percentage of responders
Interval 0.42 to 64.12
|
33.3 percentage of responders
Interval 7.49 to 70.07
|
0 percentage of responders
Interval 0.0 to 36.94
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade B (1990a) at Week 28
|
78.7 percentage of responders
Interval 64.34 to 89.3
|
53.7 percentage of responders
Interval 37.42 to 69.34
|
37.0 percentage of responders
Interval 23.21 to 52.45
|
71.1 percentage of responders
Interval 55.69 to 83.63
|
61.9 percentage of responders
Interval 45.64 to 76.43
|
72.5 percentage of responders
Interval 56.11 to 85.4
|
36.4 percentage of responders
Interval 2.41 to 52.23
|
0 percentage of responders
Interval 0.0 to 7.71
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (C97ZA.012) at Week 28
|
72.3 percentage of responders
Interval 57.36 to 84.38
|
53.7 percentage of responders
Interval 37.42 to 69.34
|
19.6 percentage of responders
Interval 9.36 to 33.91
|
57.8 percentage of responders
Interval 42.15 to 72.34
|
50.0 percentage of responders
Interval 34.19 to 65.81
|
37.5 percentage of responders
Interval 22.73 to 54.2
|
45.5 percentage of responders
Interval 30.39 to 61.15
|
0 percentage of responders
Interval 0.0 to 7.71
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (Con C) at Week 16
|
30.0 percentage of responders
Interval 6.67 to 65.25
|
30.0 percentage of responders
Interval 6.67 to 65.25
|
0 percentage of responders
Interval 0.0 to 30.85
|
55.6 percentage of responders
Interval 21.2 to 86.3
|
37.5 percentage of responders
Interval 8.52 to 75.51
|
0 percentage of responders
Interval 0.0 to 45.93
|
11.1 percentage of responders
Interval 0.28 to 48.25
|
0 percentage of responders
Interval 0.0 to 36.94
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (Con C) at Week 28
|
55.3 percentage of responders
Interval 40.12 to 69.83
|
39.0 percentage of responders
Interval 24.2 to 55.5
|
41.3 percentage of responders
Interval 27.0 to 56.77
|
53.3 percentage of responders
Interval 37.87 to 68.34
|
45.2 percentage of responders
Interval 29.85 to 61.33
|
47.5 percentage of responders
Interval 31.51 to 63.87
|
43.2 percentage of responders
Interval 28.35 to 58.97
|
8.7 percentage of responders
Interval 2.42 to 20.79
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (C97ZA.012) at Week 16
|
20.0 percentage of responders
Interval 2.52 to 55.61
|
40.0 percentage of responders
Interval 12.16 to 73.76
|
30.0 percentage of responders
Interval 6.67 to 65.25
|
44.4 percentage of responders
Interval 13.7 to 78.8
|
12.5 percentage of responders
Interval 0.32 to 52.65
|
0 percentage of responders
Interval 0.0 to 45.93
|
11.1 percentage of responders
Interval 0.28 to 48.25
|
0 percentage of responders
Interval 0.0 to 36.94
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (C97ZA.012) at Week 26
|
93.5 percentage of responders
Interval 82.1 to 98.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (C97ZA.012) at Week 52
|
80.0 percentage of responders
Interval 65.4 to 90.42
|
64.1 percentage of responders
Interval 47.18 to 78.8
|
23.8 percentage of responders
Interval 12.05 to 39.45
|
70.7 percentage of responders
Interval 54.46 to 83.87
|
60.0 percentage of responders
Interval 43.33 to 75.14
|
21.4 percentage of responders
Interval 10.3 to 36.81
|
71.1 percentage of responders
Interval 54.1 to 84.58
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (C97ZA.012) at Week 78
|
29.5 percentage of responders
Interval 16.76 to 45.2
|
15.4 percentage of responders
Interval 5.86 to 30.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Clade C (C97ZA.012) at Week 96
|
9.5 percentage of responders
Interval 2.66 to 22.62
|
10.5 percentage of responders
Interval 2.94 to 24.8
|
0 percentage of responders
Interval 0.0 to 13.72
|
18.2 percentage of responders
Interval 5.19 to 40.28
|
4.2 percentage of responders
Interval 0.11 to 21.12
|
0 percentage of responders
Interval 0.0 to 13.72
|
12.5 percentage of responders
Interval 2.66 to 32.36
|
—
|
|
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
Mos1 at Week 16
|
90.0 percentage of responders
Interval 55.5 to 99.75
|
90.0 percentage of responders
Interval 55.5 to 99.75
|
70.0 percentage of responders
Interval 34.75 to 93.33
|
77.8 percentage of responders
Interval 39.99 to 97.19
|
100.0 percentage of responders
Interval 63.06 to 100.0
|
83.3 percentage of responders
Interval 35.88 to 99.58
|
88.9 percentage of responders
Interval 51.75 to 99.72
|
0 percentage of responders
Interval 0.0 to 36.94
|
SECONDARY outcome
Timeframe: Week 28 and 52Population: PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value \>LLOQ. The LLOQ for this assay is an inhibitory concentration (IC50) of 20 (fold-dilution). Data reported for the responses against Tier 1 HIV strain Clade C (MW965.26) was reported. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=48 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=41 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=46 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=45 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=42 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=46 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
Clade C (MW965.26) Tier 1 at Week 28
|
54.2 percentage of responders
Interval 39.17 to 68.63
|
41.5 percentage of responders
Interval 26.32 to 57.89
|
21.7 percentage of responders
Interval 10.95 to 36.36
|
51.1 percentage of responders
Interval 35.77 to 66.3
|
43.2 percentage of responders
Interval 28.35 to 58.97
|
36.6 percentage of responders
Interval 22.12 to 53.06
|
29.5 percentage of responders
Interval 16.76 to 45.2
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
|
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
Clade C (MW965.26) Tier 1 at Week 52
|
75.6 percentage of responders
Interval 60.46 to 87.12
|
65.8 percentage of responders
Interval 48.65 to 80.37
|
11.9 percentage of responders
Interval 3.98 to 25.63
|
73.2 percentage of responders
Interval 57.06 to 85.78
|
52.5 percentage of responders
Interval 36.13 to 68.49
|
45.2 percentage of responders
Interval 29.85 to 61.33
|
68.4 percentage of responders
Interval 51.35 to 82.5
|
2.4 percentage of responders
Interval 0.06 to 12.86
|
SECONDARY outcome
Timeframe: Week 16, 28, 52, 78, and 96Population: PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
The human immunodeficiency virus (HIV)-1 BAMA employs flow-cytometric-based technology that also utilizes antibody and antigen interactions to test for the presence of specific antibodies in an unknown sample with the added advantage of multiplexing the antigens of interest. Positive and negative control standards were run with each assay to ensure specificity. The positivity threshold was determined per antigen based on the plus (+) 3 standard deviation (SD) on the non-specific background. Sample values had to be greater than or equal to this value and had to be 3-fold over the baseline values with a minimum median fluorescent intensities (MFI) value of 100. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=48 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=40 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=46 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=43 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=45 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (SC42261) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (SC42261) IgG-t Ab at W96
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
93.5 percentage of responders
Interval 78.58 to 99.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CH505TF) IgG-t Ab at W16
|
88.6 percentage of responders
Interval 75.44 to 96.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CH505TF) IgG-t Ab at W28
|
93.5 percentage of responders
Interval 82.1 to 98.63
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
93.0 percentage of responders
Interval 80.94 to 98.54
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
95.2 percentage of responders
Interval 83.84 to 99.42
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CH505TF) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
92.3 percentage of responders
Interval 79.13 to 98.38
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CH505TF) IgG-t Ab at W96
|
81.6 percentage of responders
Interval 65.67 to 92.26
|
77.4 percentage of responders
Interval 58.9 to 90.41
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade A (9004S) IgG-t Ab at W28
|
91.3 percentage of responders
Interval 79.21 to 97.58
|
94.3 percentage of responders
Interval 80.84 to 99.3
|
90.7 percentage of responders
Interval 77.86 to 97.41
|
90.0 percentage of responders
Interval 76.34 to 97.21
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
88.1 percentage of responders
Interval 74.37 to 96.02
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade A (9004S) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
94.9 percentage of responders
Interval 82.68 to 99.37
|
100.0 percentage of responders
Interval 89.72 to 100.0
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade A (9004S) IgG-t Ab at W78
|
87.2 percentage of responders
Interval 72.57 to 95.7
|
84.8 percentage of responders
Interval 68.1 to 94.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (RHPA) IgG-t Ab at W28
|
97.8 percentage of responders
Interval 88.47 to 99.94
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
95.2 percentage of responders
Interval 83.84 to 99.42
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (RHPA) IgG-t Ab at W96
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
93.5 percentage of responders
Interval 78.58 to 99.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (WITO) IgG-t Ab at W16
|
93.2 percentage of responders
Interval 81.34 to 98.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (WITO) IgG-t Ab at W28
|
97.8 percentage of responders
Interval 88.47 to 99.94
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
97.7 percentage of responders
Interval 87.71 to 99.94
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
95.2 percentage of responders
Interval 83.84 to 99.42
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (WITO) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
97.4 percentage of responders
Interval 86.52 to 99.94
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (WITO) IgG-t Ab at W78
|
87.2 percentage of responders
Interval 72.57 to 95.7
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (WITO) IgG-t Ab at W96
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
93.5 percentage of responders
Interval 78.58 to 99.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (1086C) IgG-t Ab at W16
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (1086C) IgG-t Ab at W28
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
97.5 percentage of responders
Interval 86.84 to 99.94
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.6 percentage of responders
Interval 87.43 to 99.94
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (1086C) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (1086C) IgG-t Ab at W78
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (1086C) IgG-t Ab at W96
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
96.8 percentage of responders
Interval 83.3 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (BF1266) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
100.0 percentage of responders
Interval 89.72 to 100.0
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
89.7 percentage of responders
Interval 75.78 to 97.13
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
5.6 percentage of responders
Interval 0.68 to 18.66
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (C2101) IgG-t Ab at W52
|
73.0 percentage of responders
Interval 55.88 to 86.21
|
59.4 percentage of responders
Interval 40.64 to 76.3
|
61.5 percentage of responders
Interval 44.62 to 76.64
|
79.4 percentage of responders
Interval 62.1 to 91.3
|
69.7 percentage of responders
Interval 51.29 to 84.41
|
55.3 percentage of responders
Interval 38.3 to 71.38
|
36.4 percentage of responders
Interval 20.4 to 54.88
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (CM244) IgG-t Ab at W28
|
58.7 percentage of responders
Interval 43.23 to 73.0
|
37.1 percentage of responders
Interval 21.47 to 55.08
|
46.5 percentage of responders
Interval 31.18 to 62.35
|
57.5 percentage of responders
Interval 40.89 to 72.96
|
29.4 percentage of responders
Interval 15.1 to 47.48
|
42.1 percentage of responders
Interval 26.31 to 59.18
|
28.6 percentage of responders
Interval 15.72 to 44.58
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (CM244) IgG-t Ab at W52
|
83.8 percentage of responders
Interval 67.99 to 93.81
|
56.3 percentage of responders
Interval 37.66 to 73.64
|
56.4 percentage of responders
Interval 39.62 to 72.19
|
76.5 percentage of responders
Interval 58.83 to 89.25
|
57.6 percentage of responders
Interval 39.22 to 74.52
|
57.9 percentage of responders
Interval 40.82 to 73.69
|
42.4 percentage of responders
Interval 25.48 to 60.78
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (CM244) IgG-t Ab at W78
|
23.1 percentage of responders
Interval 11.13 to 39.33
|
12.1 percentage of responders
Interval 3.4 to 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (62357.14) IgG-t Ab at W16
|
22.7 percentage of responders
Interval 11.47 to 37.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (62357.14) IgG-t Ab at W52
|
59.5 percentage of responders
Interval 42.1 to 75.25
|
34.4 percentage of responders
Interval 18.57 to 53.19
|
20.5 percentage of responders
Interval 9.3 to 36.46
|
61.8 percentage of responders
Interval 43.56 to 77.83
|
45.5 percentage of responders
Interval 28.11 to 63.65
|
26.3 percentage of responders
Interval 13.4 to 43.1
|
36.4 percentage of responders
Interval 20.4 to 54.88
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (62357.14) IgG-t Ab at W78
|
20.5 percentage of responders
Interval 9.3 to 36.46
|
9.1 percentage of responders
Interval 1.92 to 24.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (RHPA4259) IgG-t Ab at W78
|
33.3 percentage of responders
Interval 19.09 to 50.22
|
18.2 percentage of responders
Interval 6.98 to 35.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp70 IgG-t Ab at W78
|
36.8 percentage of responders
Interval 21.81 to 54.01
|
24.2 percentage of responders
Interval 11.09 to 42.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B(700010058) IgG-t Ab at W52
|
64.9 percentage of responders
Interval 47.46 to 79.79
|
62.5 percentage of responders
Interval 43.69 to 78.9
|
64.1 percentage of responders
Interval 47.18 to 78.8
|
70.6 percentage of responders
Interval 52.52 to 84.9
|
66.7 percentage of responders
Interval 48.17 to 82.04
|
57.9 percentage of responders
Interval 40.82 to 73.69
|
33.3 percentage of responders
Interval 17.96 to 51.83
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B(700010058) IgG-t Ab at W78
|
28.2 percentage of responders
Interval 15.0 to 44.87
|
30.3 percentage of responders
Interval 15.59 to 48.71
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (96ZM651) IgG-t Ab at W52
|
54.1 percentage of responders
Interval 36.92 to 70.51
|
40.6 percentage of responders
Interval 23.7 to 59.36
|
20.5 percentage of responders
Interval 9.3 to 36.46
|
61.8 percentage of responders
Interval 43.56 to 77.83
|
36.4 percentage of responders
Interval 20.4 to 54.88
|
36.8 percentage of responders
Interval 21.81 to 54.01
|
30.3 percentage of responders
Interval 15.59 to 48.71
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CAP210) IgG-t Ab at W28
|
47.8 percentage of responders
Interval 32.89 to 63.05
|
42.9 percentage of responders
Interval 26.32 to 60.65
|
32.6 percentage of responders
Interval 19.08 to 48.54
|
50.0 percentage of responders
Interval 33.8 to 66.2
|
25.7 percentage of responders
Interval 12.49 to 43.26
|
21.1 percentage of responders
Interval 9.55 to 37.32
|
26.2 percentage of responders
Interval 13.86 to 42.04
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CAP210) IgG-t Ab at W52
|
67.6 percentage of responders
Interval 50.21 to 81.99
|
53.1 percentage of responders
Interval 34.74 to 70.91
|
43.6 percentage of responders
Interval 27.81 to 60.38
|
67.6 percentage of responders
Interval 49.47 to 82.61
|
51.5 percentage of responders
Interval 33.54 to 69.2
|
39.5 percentage of responders
Interval 24.04 to 56.61
|
48.5 percentage of responders
Interval 30.8 to 66.46
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(Ce1086) IgG-t Ab at W52
|
81.1 percentage of responders
Interval 64.84 to 92.04
|
65.6 percentage of responders
Interval 46.81 to 81.43
|
64.1 percentage of responders
Interval 47.18 to 78.8
|
85.3 percentage of responders
Interval 68.94 to 95.05
|
72.7 percentage of responders
Interval 54.48 to 86.7
|
68.4 percentage of responders
Interval 51.35 to 82.5
|
54.5 percentage of responders
Interval 36.35 to 71.89
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(Ce1086) IgG-t Ab at W78
|
28.2 percentage of responders
Interval 15.0 to 44.87
|
18.2 percentage of responders
Interval 6.98 to 35.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(Ce1086) IgG-t Ab at W96
|
23.7 percentage of responders
Interval 11.44 to 40.24
|
22.6 percentage of responders
Interval 9.59 to 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(TV1.21)IgG-t Ab at W28
|
78.3 percentage of responders
Interval 63.64 to 89.05
|
54.3 percentage of responders
Interval 36.65 to 71.17
|
48.8 percentage of responders
Interval 33.31 to 64.54
|
62.5 percentage of responders
Interval 45.8 to 77.27
|
48.6 percentage of responders
Interval 31.38 to 66.01
|
39.5 percentage of responders
Interval 24.04 to 56.61
|
50.0 percentage of responders
Interval 34.19 to 65.81
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (001428)IgG-t Ab at W28
|
56.5 percentage of responders
Interval 41.11 to 71.07
|
40.0 percentage of responders
Interval 23.87 to 57.89
|
37.2 percentage of responders
Interval 22.98 to 53.27
|
57.5 percentage of responders
Interval 40.89 to 72.96
|
28.6 percentage of responders
Interval 14.64 to 46.3
|
31.6 percentage of responders
Interval 17.5 to 48.65
|
35.7 percentage of responders
Interval 21.55 to 51.97
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W52
|
2.2 percentage of responders
Interval 0.06 to 11.77
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.41
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
2.7 percentage of responders
Interval 0.07 to 14.16
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W28
|
12.5 percentage of responders
Interval 4.73 to 25.25
|
12.5 percentage of responders
Interval 4.19 to 26.8
|
11.1 percentage of responders
Interval 3.71 to 24.05
|
18.6 percentage of responders
Interval 8.39 to 33.4
|
11.6 percentage of responders
Interval 3.89 to 25.08
|
12.2 percentage of responders
Interval 4.08 to 26.2
|
7.0 percentage of responders
Interval 1.46 to 19.06
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W28
|
12.5 percentage of responders
Interval 4.73 to 25.25
|
10.0 percentage of responders
Interval 2.79 to 23.66
|
13.0 percentage of responders
Interval 4.94 to 26.26
|
9.3 percentage of responders
Interval 2.59 to 22.14
|
9.1 percentage of responders
Interval 2.53 to 21.67
|
7.3 percentage of responders
Interval 1.54 to 19.92
|
16.3 percentage of responders
Interval 6.81 to 30.7
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W28
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
0 percentage of responders
Interval 0.0 to 7.71
|
4.7 percentage of responders
Interval 0.57 to 15.81
|
0 percentage of responders
Interval 0.0 to 8.04
|
0 percentage of responders
Interval 0.0 to 8.6
|
7.0 percentage of responders
Interval 1.46 to 19.06
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W52
|
2.2 percentage of responders
Interval 0.06 to 11.77
|
5.4 percentage of responders
Interval 0.66 to 18.19
|
4.8 percentage of responders
Interval 0.58 to 16.16
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
2.4 percentage of responders
Interval 0.06 to 12.86
|
5.4 percentage of responders
Interval 0.66 to 18.19
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W28
|
0 percentage of responders
Interval 0.0 to 7.4
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 7.71
|
2.3 percentage of responders
Interval 0.06 to 12.29
|
0 percentage of responders
Interval 0.0 to 8.04
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W52
|
0 percentage of responders
Interval 0.0 to 7.87
|
2.7 percentage of responders
Interval 0.07 to 14.16
|
0 percentage of responders
Interval 0.0 to 8.41
|
5.3 percentage of responders
Interval 0.64 to 17.75
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
2.4 percentage of responders
Interval 0.06 to 12.86
|
2.7 percentage of responders
Interval 0.07 to 14.16
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W16
|
60.0 percentage of responders
Interval 43.33 to 75.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W28
|
76.9 percentage of responders
Interval 60.67 to 88.87
|
87.1 percentage of responders
Interval 70.17 to 96.37
|
77.8 percentage of responders
Interval 60.85 to 89.88
|
82.9 percentage of responders
Interval 66.35 to 93.44
|
85.3 percentage of responders
Interval 68.94 to 95.05
|
78.9 percentage of responders
Interval 62.68 to 90.45
|
83.8 percentage of responders
Interval 67.99 to 93.81
|
0 percentage of responders
Interval 0.0 to 9.25
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W52
|
77.1 percentage of responders
Interval 59.86 to 89.58
|
92.0 percentage of responders
Interval 73.97 to 99.02
|
61.3 percentage of responders
Interval 42.19 to 78.15
|
84.6 percentage of responders
Interval 65.13 to 95.64
|
69.2 percentage of responders
Interval 48.21 to 85.67
|
68.8 percentage of responders
Interval 49.99 to 83.88
|
86.2 percentage of responders
Interval 68.34 to 96.11
|
0 percentage of responders
Interval 0.0 to 10.89
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W16
|
52.5 percentage of responders
Interval 36.13 to 68.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W28
|
59.0 percentage of responders
Interval 42.1 to 74.43
|
45.2 percentage of responders
Interval 27.32 to 63.97
|
44.4 percentage of responders
Interval 27.94 to 61.9
|
45.7 percentage of responders
Interval 28.83 to 63.35
|
47.1 percentage of responders
Interval 29.78 to 64.87
|
39.5 percentage of responders
Interval 24.04 to 56.61
|
48.6 percentage of responders
Interval 31.92 to 65.6
|
0 percentage of responders
Interval 0.0 to 9.25
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W52
|
60.0 percentage of responders
Interval 42.11 to 76.13
|
40.0 percentage of responders
Interval 21.13 to 61.33
|
45.2 percentage of responders
Interval 27.32 to 63.97
|
50.0 percentage of responders
Interval 29.93 to 70.07
|
42.3 percentage of responders
Interval 23.35 to 63.08
|
43.8 percentage of responders
Interval 26.36 to 62.34
|
55.2 percentage of responders
Interval 35.69 to 73.55
|
0 percentage of responders
Interval 0.0 to 10.89
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W28
|
71.8 percentage of responders
Interval 55.13 to 85.0
|
77.4 percentage of responders
Interval 58.9 to 90.41
|
61.1 percentage of responders
Interval 43.46 to 76.86
|
74.3 percentage of responders
Interval 56.74 to 87.51
|
79.4 percentage of responders
Interval 62.1 to 91.3
|
68.4 percentage of responders
Interval 51.35 to 82.5
|
78.4 percentage of responders
Interval 61.79 to 90.17
|
0 percentage of responders
Interval 0.0 to 9.25
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W52
|
74.3 percentage of responders
Interval 56.74 to 87.51
|
68.0 percentage of responders
Interval 46.5 to 85.05
|
41.9 percentage of responders
Interval 24.55 to 60.92
|
76.9 percentage of responders
Interval 56.35 to 91.03
|
73.1 percentage of responders
Interval 52.21 to 88.43
|
59.4 percentage of responders
Interval 40.64 to 76.3
|
65.5 percentage of responders
Interval 45.67 to 82.06
|
0 percentage of responders
Interval 0.0 to 11.22
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W16
|
30.0 percentage of responders
Interval 16.56 to 46.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W28
|
46.2 percentage of responders
Interval 30.09 to 62.82
|
51.6 percentage of responders
Interval 33.06 to 69.85
|
41.7 percentage of responders
Interval 25.51 to 59.24
|
59.24 percentage of responders
Interval 31.38 to 66.01
|
47.1 percentage of responders
Interval 29.78 to 64.87
|
36.8 percentage of responders
Interval 21.81 to 54.01
|
62.2 percentage of responders
Interval 44.76 to 77.54
|
0 percentage of responders
Interval 0.0 to 9.25
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W16
|
45.0 percentage of responders
Interval 29.26 to 61.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W28
|
56.4 percentage of responders
Interval 39.62 to 72.19
|
64.5 percentage of responders
Interval 45.37 to 80.77
|
41.7 percentage of responders
Interval 25.51 to 59.24
|
51.4 percentage of responders
Interval 33.99 to 68.62
|
52.9 percentage of responders
Interval 35.13 to 70.22
|
47.4 percentage of responders
Interval 30.98 to 64.18
|
48.6 percentage of responders
Interval 31.92 to 65.6
|
0 percentage of responders
Interval 0.0 to 9.25
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgA Ab at W16
|
10.0 percentage of responders
Interval 2.79 to 23.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgA Ab at W28
|
48.7 percentage of responders
Interval 32.42 to 65.22
|
29.0 percentage of responders
Interval 14.22 to 48.04
|
11.1 percentage of responders
Interval 3.11 to 26.06
|
42.9 percentage of responders
Interval 26.32 to 60.65
|
32.4 percentage of responders
Interval 17.39 to 50.53
|
7.9 percentage of responders
Interval 1.66 to 21.38
|
37.8 percentage of responders
Interval 22.46 to 55.24
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgA Ab at W52
|
48.6 percentage of responders
Interval 31.38 to 66.01
|
36.0 percentage of responders
Interval 17.97 to 57.48
|
9.7 percentage of responders
Interval 2.04 to 25.75
|
53.8 percentage of responders
Interval 33.37 to 73.41
|
46.2 percentage of responders
Interval 26.59 to 66.63
|
12.5 percentage of responders
Interval 3.51 to 28.99
|
58.6 percentage of responders
Interval 38.94 to 76.48
|
0 percentage of responders
Interval 0.0 to 10.89
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (51802) IgG-t Ab at W16
|
72.7 percentage of responders
Interval 57.21 to 85.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (51802) IgG-t Ab at W28
|
91.3 percentage of responders
Interval 79.21 to 97.58
|
94.3 percentage of responders
Interval 80.84 to 99.3
|
88.4 percentage of responders
Interval 74.92 to 96.11
|
87.5 percentage of responders
Interval 73.2 to 95.81
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
94.7 percentage of responders
Interval 82.25 to 99.36
|
85.7 percentage of responders
Interval 71.46 to 94.57
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (51802) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
87.2 percentage of responders
Interval 72.57 to 95.7
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
86.8 percentage of responders
Interval 71.91 to 95.59
|
90.9 percentage of responders
Interval 75.67 to 98.08
|
5.6 percentage of responders
Interval 0.68 to 18.66
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (51802) IgG-t Ab at W96
|
68.4 percentage of responders
Interval 51.35 to 82.5
|
74.2 percentage of responders
Interval 55.39 to 88.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (254008) IgG-t Ab at W16
|
84.1 percentage of responders
Interval 69.93 to 93.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (254008) IgG-t Ab at W28
|
89.1 percentage of responders
Interval 76.43 to 96.38
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
88.4 percentage of responders
Interval 74.92 to 96.11
|
85.0 percentage of responders
Interval 70.16 to 94.29
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
88.1 percentage of responders
Interval 74.37 to 96.02
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (254008) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
87.2 percentage of responders
Interval 72.57 to 95.7
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (254008) IgG-t Ab at W78
|
97.4 percentage of responders
Interval 86.52 to 99.94
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (254008) IgG-t Ab at W96
|
94.7 percentage of responders
Interval 82.25 to 99.36
|
90.3 percentage of responders
Interval 74.25 to 97.96
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (A244) IgG-t Ab at W16
|
75.0 percentage of responders
Interval 59.66 to 86.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (A244) IgG-t Ab at W28
|
91.3 percentage of responders
Interval 79.21 to 97.58
|
91.4 percentage of responders
Interval 76.94 to 98.2
|
81.4 percentage of responders
Interval 66.6 to 91.61
|
90.0 percentage of responders
Interval 76.34 to 97.21
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
94.7 percentage of responders
Interval 82.25 to 99.36
|
88.1 percentage of responders
Interval 74.37 to 96.02
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (A244) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
89.7 percentage of responders
Interval 75.78 to 97.13
|
91.2 percentage of responders
Interval 76.32 to 98.14
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
89.5 percentage of responders
Interval 75.2 to 97.06
|
90.9 percentage of responders
Interval 75.67 to 98.08
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (A244) IgG-t Ab at W78
|
84.6 percentage of responders
Interval 69.47 to 94.14
|
84.8 percentage of responders
Interval 68.1 to 94.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (A244) IgG-t Ab at W96
|
71.1 percentage of responders
Interval 54.1 to 84.58
|
71.0 percentage of responders
Interval 51.96 to 85.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (B.6240) IgG-t Ab at W16
|
86.4 percentage of responders
Interval 72.65 to 94.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (B.6240) IgG-t Ab at W28
|
95.7 percentage of responders
Interval 85.16 to 99.47
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
97.7 percentage of responders
Interval 87.71 to 99.94
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
90.5 percentage of responders
Interval 77.38 to 97.34
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (B.6240) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
92.3 percentage of responders
Interval 79.13 to 98.38
|
94.1 percentage of responders
Interval 80.32 to 99.28
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (B.6240) IgG-t Ab at W78
|
84.6 percentage of responders
Interval 69.47 to 94.14
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (B.6240) IgG-t Ab at W96
|
86.8 percentage of responders
Interval 71.91 to 95.59
|
93.5 percentage of responders
Interval 78.58 to 99.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (BORI) IgG-t Ab at W28
|
95.7 percentage of responders
Interval 85.16 to 99.47
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
93.0 percentage of responders
Interval 80.94 to 98.54
|
90.0 percentage of responders
Interval 76.34 to 97.21
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
90.5 percentage of responders
Interval 77.38 to 97.34
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (BORI) IgG-t Ab at Week 52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
97.4 percentage of responders
Interval 86.52 to 99.94
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (BORI) IgG-t Ab at W96
|
73.7 percentage of responders
Interval 56.9 to 86.6
|
74.2 percentage of responders
Interval 55.39 to 88.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp120 IgG-t Ab at W28
|
95.7 percentage of responders
Interval 85.16 to 99.47
|
91.4 percentage of responders
Interval 76.94 to 98.2
|
90.7 percentage of responders
Interval 77.86 to 97.41
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
88.1 percentage of responders
Interval 74.37 to 96.02
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp120 IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
94.9 percentage of responders
Interval 82.68 to 99.37
|
94.1 percentage of responders
Interval 80.32 to 99.28
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
90.9 percentage of responders
Interval 75.67 to 98.08
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp120 IgG-t Ab at W78
|
87.2 percentage of responders
Interval 72.57 to 95.7
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp120 IgG-t Ab at W96
|
86.8 percentage of responders
Interval 71.91 to 95.59
|
87.1 percentage of responders
Interval 70.17 to 96.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (CNE20) IgG-t Ab at W28
|
93.5 percentage of responders
Interval 82.1 to 98.63
|
94.3 percentage of responders
Interval 80.84 to 99.3
|
90.7 percentage of responders
Interval 77.86 to 97.41
|
90.0 percentage of responders
Interval 76.34 to 97.21
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
92.9 percentage of responders
Interval 80.52 to 98.5
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (CNE20) IgG-t Ab at W78
|
84.6 percentage of responders
Interval 69.47 to 94.14
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC(BJOX002) IgG-t Ab at W28
|
87.0 percentage of responders
Interval 73.74 to 95.06
|
94.3 percentage of responders
Interval 80.84 to 99.3
|
88.4 percentage of responders
Interval 74.92 to 96.11
|
85.0 percentage of responders
Interval 70.16 to 94.29
|
82.9 percentage of responders
Interval 66.35 to 93.44
|
89.5 percentage of responders
Interval 75.2 to 97.06
|
90.5 percentage of responders
Interval 77.38 to 97.34
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC(BJOX002) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
89.7 percentage of responders
Interval 75.78 to 97.13
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
94.7 percentage of responders
Interval 82.25 to 99.36
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC(BJOX002) IgG-t Ab at W96
|
68.4 percentage of responders
Interval 51.35 to 82.5
|
74.2 percentage of responders
Interval 55.39 to 88.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(1086C_D7) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
B Clade M (Con 6) IgG-t Ab at W28
|
97.8 percentage of responders
Interval 88.47 to 99.94
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
97.7 percentage of responders
Interval 87.71 to 99.94
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
92.9 percentage of responders
Interval 80.52 to 98.5
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI(Clade M)IgG1 Ab Week(W)16
|
76.6 percentage of responders
Interval 61.97 to 87.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W28
|
95.8 percentage of responders
Interval 85.75 to 99.49
|
94.6 percentage of responders
Interval 81.81 to 99.34
|
76.1 percentage of responders
Interval 61.23 to 87.41
|
90.9 percentage of responders
Interval 78.33 to 97.47
|
97.6 percentage of responders
Interval 87.14 to 99.94
|
95.1 percentage of responders
Interval 83.47 to 99.4
|
88.4 percentage of responders
Interval 74.92 to 96.11
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (BF1266) IgG-t Ab at W78
|
92.3 percentage of responders
Interval 79.13 to 98.38
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (BF1266) IgG-t Ab at Week 96
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
93.5 percentage of responders
Interval 78.58 to 99.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CF Clade AE (conAE) IgG-t Ab at 16
|
88.6 percentage of responders
Interval 75.44 to 96.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CF Clade AE (conAE) IgG-t Ab at W28
|
95.7 percentage of responders
Interval 85.16 to 99.47
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
93.0 percentage of responders
Interval 80.94 to 98.54
|
90.0 percentage of responders
Interval 76.34 to 97.21
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
95.2 percentage of responders
Interval 83.84 to 99.42
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CF Clade AE (conAE) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
92.3 percentage of responders
Interval 79.13 to 98.38
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CF Clade AE (conAE) IgG-t Ab at W78
|
92.3 percentage of responders
Interval 79.13 to 98.38
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CF Clade AE (conAE) IgG-t Ab at W96
|
84.2 percentage of responders
Interval 68.75 to 93.98
|
87.1 percentage of responders
Interval 70.17 to 96.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CFI Clade M(Con S) IgG-t Ab at W16
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CFI Clade M(Con S) IgG-t Ab at W28
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
97.5 percentage of responders
Interval 86.84 to 99.94
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.6 percentage of responders
Interval 87.43 to 99.94
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CFI Clade M(Con S) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CFI Clade M(Con S) IgG-t Ab at W78
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
CFI Clade M(Con S) IgG-t Ab at Week 96
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
96.8 percentage of responders
Interval 83.3 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
IgG-t Ab at W16
|
72.7 percentage of responders
Interval 57.21 to 85.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
IgG-t Ab at W28
|
95.7 percentage of responders
Interval 85.16 to 99.47
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
79.1 percentage of responders
Interval 63.96 to 89.96
|
87.5 percentage of responders
Interval 73.2 to 95.81
|
85.7 percentage of responders
Interval 69.74 to 95.19
|
89.5 percentage of responders
Interval 75.2 to 97.06
|
90.5 percentage of responders
Interval 77.38 to 97.34
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CAP210) IgG-t Ab at W78
|
25.6 percentage of responders
Interval 13.04 to 42.13
|
18.2 percentage of responders
Interval 6.98 to 35.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CAP210) IgG-t Ab at W96
|
21.1 percentage of responders
Interval 9.55 to 37.32
|
16.1 percentage of responders
Interval 5.45 to 33.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(Ce1086) IgG-t Ab at W16
|
47.7 percentage of responders
Interval 32.46 to 63.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(Ce1086) IgG-t Ab at W28
|
65.2 percentage of responders
Interval 49.75 to 78.65
|
48.6 percentage of responders
Interval 31.38 to 66.01
|
55.8 percentage of responders
Interval 39.88 to 70.92
|
60.0 percentage of responders
Interval 43.33 to 75.14
|
41.2 percentage of responders
Interval 24.65 to 59.3
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
35.7 percentage of responders
Interval 21.55 to 51.97
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
IgG-t Ab at W78
|
87.2 percentage of responders
Interval 72.57 to 95.7
|
81.8 percentage of responders
Interval 64.54 to 93.02
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
IgG-t Ab at W96
|
81.6 percentage of responders
Interval 65.67 to 92.26
|
67.7 percentage of responders
Interval 48.63 to 83.32
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (191084) IgG-t Ab at W16
|
47.7 percentage of responders
Interval 32.46 to 63.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (191084) IgG-t Ab at W28
|
65.2 percentage of responders
Interval 49.75 to 78.65
|
45.7 percentage of responders
Interval 28.83 to 63.35
|
46.5 percentage of responders
Interval 31.18 to 62.35
|
60.0 percentage of responders
Interval 43.33 to 75.14
|
42.9 percentage of responders
Interval 26.32 to 60.65
|
47.4 percentage of responders
Interval 30.98 to 64.18
|
38.1 percentage of responders
Interval 23.57 to 54.36
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(TV1.21)IgG-t Ab at W16
|
56.8 percentage of responders
Interval 41.03 to 71.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(TV1.21)IgG-t Ab at W52
|
89.2 percentage of responders
Interval 74.58 to 96.97
|
68.8 percentage of responders
Interval 49.99 to 83.88
|
64.1 percentage of responders
Interval 47.18 to 78.8
|
79.4 percentage of responders
Interval 62.1 to 91.3
|
78.8 percentage of responders
Interval 61.09 to 91.02
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
66.7 percentage of responders
Interval 48.17 to 82.04
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(TV1.21)IgG-t Ab at W78
|
38.5 percentage of responders
Interval 23.36 to 55.38
|
27.3 percentage of responders
Interval 13.3 to 45.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(TV1.21)IgG-t Ab at W96
|
29.7 percentage of responders
Interval 15.87 to 46.98
|
26.7 percentage of responders
Interval 12.28 to 45.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (001428)IgG-t Ab at W16
|
45.5 percentage of responders
Interval 30.39 to 61.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (001428)IgG-t Ab at W52
|
81.1 percentage of responders
Interval 64.84 to 92.04
|
68.8 percentage of responders
Interval 49.99 to 83.88
|
53.8 percentage of responders
Interval 37.18 to 69.91
|
73.5 percentage of responders
Interval 55.64 to 87.12
|
66.7 percentage of responders
Interval 48.17 to 82.04
|
42.1 percentage of responders
Interval 26.31 to 59.18
|
57.6 percentage of responders
Interval 39.22 to 74.52
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (001428)IgG-t Ab at W78
|
35.0 percentage of responders
Interval 20.63 to 51.68
|
25.0 percentage of responders
Interval 11.46 to 43.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (001428)IgG-t Ab at W96
|
28.2 percentage of responders
Interval 15.0 to 44.87
|
26.7 percentage of responders
Interval 12.28 to 45.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (7060101641)IgG-t Ab at W16
|
47.7 percentage of responders
Interval 32.46 to 63.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (7060101641)IgG-t Ab at W28
|
63.0 percentage of responders
Interval 47.55 to 76.79
|
42.9 percentage of responders
Interval 26.32 to 60.65
|
48.8 percentage of responders
Interval 33.31 to 64.54
|
57.5 percentage of responders
Interval 40.89 to 72.96
|
34.3 percentage of responders
Interval 19.13 to 52.21
|
42.1 percentage of responders
Interval 26.31 to 59.18
|
33.3 percentage of responders
Interval 19.57 to 49.55
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (7060101641)IgG-t Ab at W52
|
81.1 percentage of responders
Interval 64.84 to 92.04
|
62.5 percentage of responders
Interval 43.69 to 78.9
|
59.0 percentage of responders
Interval 42.1 to 74.43
|
67.6 percentage of responders
Interval 49.47 to 82.61
|
66.7 percentage of responders
Interval 48.17 to 82.04
|
44.7 percentage of responders
Interval 28.62 to 61.7
|
51.5 percentage of responders
Interval 33.54 to 69.2
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (7060101641)IgG-t Ab at W78
|
38.5 percentage of responders
Interval 23.36 to 55.38
|
15.2 percentage of responders
Interval 5.11 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (7060101641)IgG-t Ab at W96
|
18.4 percentage of responders
Interval 7.74 to 34.33
|
16.1 percentage of responders
Interval 5.45 to 33.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (191084) IgG-t Ab at W52
|
81.1 percentage of responders
Interval 64.84 to 92.04
|
62.5 percentage of responders
Interval 43.69 to 78.9
|
59.0 percentage of responders
Interval 42.1 to 74.43
|
73.5 percentage of responders
Interval 55.64 to 87.12
|
75.8 percentage of responders
Interval 57.74 to 88.91
|
57.9 percentage of responders
Interval 40.82 to 73.69
|
51.5 percentage of responders
Interval 33.54 to 69.2
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (191084) IgG-t Ab at W78
|
28.2 percentage of responders
Interval 15.0 to 44.87
|
18.2 percentage of responders
Interval 6.98 to 35.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (191084) IgG-t Ab at W96
|
21.1 percentage of responders
Interval 9.55 to 37.32
|
16.1 percentage of responders
Interval 5.45 to 33.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (C2101) IgG-t Ab at W16
|
47.7 percentage of responders
Interval 32.46 to 63.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (C2101) IgG-t Ab at W28
|
58.7 percentage of responders
Interval 43.23 to 73.0
|
45.7 percentage of responders
Interval 28.83 to 63.35
|
48.8 percentage of responders
Interval 33.31 to 64.54
|
62.5 percentage of responders
Interval 45.8 to 77.27
|
48.6 percentage of responders
Interval 31.38 to 66.01
|
52.6 percentage of responders
Interval 35.82 to 69.02
|
28.6 percentage of responders
Interval 15.72 to 44.58
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (SC42261) IgG-t Ab at W78
|
92.3 percentage of responders
Interval 79.13 to 98.38
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (C2101) IgG-t Ab at W78
|
28.2 percentage of responders
Interval 15.0 to 44.87
|
30.3 percentage of responders
Interval 15.59 to 48.71
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (C2101) IgG-t Ab at W96
|
21.1 percentage of responders
Interval 9.55 to 37.32
|
32.3 percentage of responders
Interval 16.68 to 51.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (CM244) IgG-t Ab at W16
|
47.7 percentage of responders
Interval 32.46 to 63.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade AE (CM244) IgG-t Ab at W96
|
21.1 percentage of responders
Interval 9.55 to 37.32
|
16.1 percentage of responders
Interval 5.45 to 33.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (62357.14) IgG-t Ab at W28
|
41.3 percentage of responders
Interval 27.0 to 56.77
|
17.1 percentage of responders
Interval 6.56 to 33.65
|
16.3 percentage of responders
Interval 6.81 to 30.7
|
37.5 percentage of responders
Interval 22.73 to 54.2
|
20.0 percentage of responders
Interval 8.44 to 36.94
|
23.7 percentage of responders
Interval 11.44 to 40.24
|
19.0 percentage of responders
Interval 8.6 to 34.12
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (62357.14) IgG-t Ab at W96
|
10.5 percentage of responders
Interval 2.94 to 24.8
|
12.9 percentage of responders
Interval 3.63 to 29.83
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (CaseA) IgG-t Ab at W16
|
59.1 percentage of responders
Interval 43.25 to 73.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (CaseA) IgG-t Ab at W28
|
67.4 percentage of responders
Interval 51.98 to 80.47
|
51.4 percentage of responders
Interval 33.99 to 68.62
|
62.8 percentage of responders
Interval 46.73 to 77.02
|
65.0 percentage of responders
Interval 48.32 to 79.37
|
42.9 percentage of responders
Interval 26.32 to 60.65
|
63.2 percentage of responders
Interval 45.99 to 78.19
|
45.2 percentage of responders
Interval 29.85 to 61.33
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (CaseA) IgG-t Ab at W52
|
86.5 percentage of responders
Interval 71.23 to 95.46
|
75.0 percentage of responders
Interval 56.6 to 88.54
|
71.8 percentage of responders
Interval 55.13 to 85.0
|
70.6 percentage of responders
Interval 52.52 to 84.9
|
81.8 percentage of responders
Interval 64.54 to 93.02
|
71.1 percentage of responders
Interval 54.1 to 84.58
|
60.6 percentage of responders
Interval 42.14 to 77.09
|
13.9 percentage of responders
Interval 4.67 to 29.5
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (CaseA) IgG-t Ab at W78
|
42.1 percentage of responders
Interval 26.31 to 59.18
|
30.3 percentage of responders
Interval 15.59 to 48.71
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (CaseA) IgG-t Ab at W96
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
29.0 percentage of responders
Interval 14.22 to 48.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (RHPA4259) IgG-t Ab at W16
|
50.0 percentage of responders
Interval 34.56 to 65.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (RHPA4259) IgG-t Ab at W28
|
69.6 percentage of responders
Interval 54.25 to 82.26
|
48.6 percentage of responders
Interval 31.38 to 66.01
|
51.2 percentage of responders
Interval 35.46 to 66.69
|
60.0 percentage of responders
Interval 43.33 to 75.14
|
47.1 percentage of responders
Interval 29.78 to 64.87
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
35.7 percentage of responders
Interval 21.55 to 51.97
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (RHPA4259) IgG-t Ab at W52
|
83.8 percentage of responders
Interval 67.99 to 93.81
|
59.4 percentage of responders
Interval 40.64 to 76.3
|
59.0 percentage of responders
Interval 42.1 to 74.43
|
67.6 percentage of responders
Interval 49.47 to 82.61
|
75.8 percentage of responders
Interval 57.74 to 88.91
|
57.9 percentage of responders
Interval 40.82 to 73.69
|
48.5 percentage of responders
Interval 30.8 to 66.46
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (RHPA4259) IgG-t Ab at W96
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
22.6 percentage of responders
Interval 9.59 to 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp70 IgG-t Ab at W16
|
59.1 percentage of responders
Interval 43.25 to 73.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp70 IgG-t Ab at W28
|
69.6 percentage of responders
Interval 54.25 to 82.26
|
45.7 percentage of responders
Interval 28.83 to 63.35
|
51.2 percentage of responders
Interval 35.46 to 66.69
|
62.5 percentage of responders
Interval 45.8 to 77.27
|
37.1 percentage of responders
Interval 21.47 to 55.08
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
50.0 percentage of responders
Interval 34.19 to 65.81
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp70 IgG-t Ab at W52
|
86.5 percentage of responders
Interval 71.23 to 95.46
|
62.5 percentage of responders
Interval 43.69 to 78.9
|
66.7 percentage of responders
Interval 49.78 to 80.91
|
73.5 percentage of responders
Interval 55.64 to 87.12
|
75.8 percentage of responders
Interval 57.74 to 88.91
|
57.9 percentage of responders
Interval 40.82 to 73.69
|
57.6 percentage of responders
Interval 39.22 to 74.52
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp70 IgG-t Ab at W96
|
31.6 percentage of responders
Interval 17.5 to 48.65
|
22.6 percentage of responders
Interval 9.59 to 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B(700010058) IgG-t Ab at W16
|
50.0 percentage of responders
Interval 34.56 to 65.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B(700010058) IgG-t Ab at W28
|
60.9 percentage of responders
Interval 45.37 to 74.91
|
45.7 percentage of responders
Interval 28.83 to 63.35
|
53.5 percentage of responders
Interval 37.65 to 68.82
|
62.5 percentage of responders
Interval 45.8 to 77.27
|
37.1 percentage of responders
Interval 21.47 to 55.08
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
26.2 percentage of responders
Interval 13.86 to 42.04
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B(700010058) IgG-t Ab at W96
|
27.0 percentage of responders
Interval 13.79 to 44.12
|
23.3 percentage of responders
Interval 9.93 to 42.28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (BJOX) IgG-t Ab at W16
|
52.3 percentage of responders
Interval 36.69 to 67.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (BJOX) IgG-t Ab at W28
|
67.4 percentage of responders
Interval 51.98 to 80.47
|
48.6 percentage of responders
Interval 31.38 to 66.01
|
55.8 percentage of responders
Interval 39.88 to 70.92
|
62.5 percentage of responders
Interval 45.8 to 77.27
|
40.0 percentage of responders
Interval 23.87 to 57.89
|
47.4 percentage of responders
Interval 30.98 to 64.18
|
35.7 percentage of responders
Interval 21.55 to 51.97
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (BJOX) IgG-t Ab at W52
|
81.1 percentage of responders
Interval 64.84 to 92.04
|
62.5 percentage of responders
Interval 43.69 to 78.9
|
66.7 percentage of responders
Interval 49.78 to 80.91
|
70.6 percentage of responders
Interval 52.52 to 84.9
|
66.7 percentage of responders
Interval 48.17 to 82.04
|
60.5 percentage of responders
Interval 43.39 to 75.96
|
54.5 percentage of responders
Interval 36.35 to 71.89
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (BJOX) IgG-t Ab at W78
|
23.1 percentage of responders
Interval 11.13 to 39.33
|
18.2 percentage of responders
Interval 6.98 to 35.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (BJOX) IgG-t Ab at W96
|
21.1 percentage of responders
Interval 9.55 to 37.32
|
22.6 percentage of responders
Interval 9.59 to 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (96ZM651) IgG-t Ab at W16
|
13.6 percentage of responders
Interval 5.17 to 27.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (96ZM651) IgG-t Ab at W28
|
28.3 percentage of responders
Interval 15.99 to 43.46
|
17.1 percentage of responders
Interval 6.56 to 33.65
|
4.7 percentage of responders
Interval 0.57 to 15.81
|
32.5 percentage of responders
Interval 18.57 to 49.13
|
20.0 percentage of responders
Interval 8.44 to 36.94
|
18.4 percentage of responders
Interval 7.74 to 34.33
|
14.3 percentage of responders
Interval 5.43 to 28.54
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (96ZM651) IgG-t Ab at W78
|
10.3 percentage of responders
Interval 2.87 to 24.22
|
9.1 percentage of responders
Interval 1.92 to 24.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (96ZM651) IgG-t Ab at W96
|
10.5 percentage of responders
Interval 2.94 to 24.8
|
6.5 percentage of responders
Interval 0.79 to 21.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (BF1266) IgG-t Ab at W16
|
43.2 percentage of responders
Interval 28.35 to 58.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (BF1266) IgG-t Ab at W28
|
58.7 percentage of responders
Interval 43.23 to 73.0
|
31.4 percentage of responders
Interval 16.85 to 49.29
|
30.2 percentage of responders
Interval 17.18 to 46.13
|
50.0 percentage of responders
Interval 33.8 to 66.2
|
34.3 percentage of responders
Interval 19.13 to 52.21
|
34.2 percentage of responders
Interval 19.63 to 51.35
|
31.0 percentage of responders
Interval 17.62 to 47.09
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (BF1266) IgG-t Ab at W52
|
78.4 percentage of responders
Interval 61.79 to 90.17
|
43.8 percentage of responders
Interval 26.36 to 62.34
|
43.6 percentage of responders
Interval 27.81 to 60.38
|
70.6 percentage of responders
Interval 52.52 to 84.9
|
51.5 percentage of responders
Interval 33.54 to 69.2
|
42.1 percentage of responders
Interval 26.31 to 59.18
|
48.5 percentage of responders
Interval 30.8 to 66.46
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (BF1266) IgG-t Ab at W78
|
17.9 percentage of responders
Interval 7.54 to 33.53
|
18.2 percentage of responders
Interval 6.98 to 35.46
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CH505TF) IgG-t Ab at W78
|
84.2 percentage of responders
Interval 68.75 to 93.98
|
90.9 percentage of responders
Interval 75.67 to 98.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade A (9004S) IgG-t Ab at W16
|
84.1 percentage of responders
Interval 69.93 to 93.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade A (9004S) IgG-t Ab at W96
|
86.8 percentage of responders
Interval 71.91 to 95.59
|
87.1 percentage of responders
Interval 70.17 to 96.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (RHPA) IgG-t Ab at W16
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (RHPA) IgG-t Ab at Week 52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade B (RHPA) IgG-t Ab at W78
|
92.3 percentage of responders
Interval 79.13 to 98.38
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (BF1266) IgG-t Ab at W96
|
18.4 percentage of responders
Interval 7.74 to 34.33
|
22.6 percentage of responders
Interval 9.59 to 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C (CAP210) IgG-t Ab at W16
|
34.1 percentage of responders
Interval 20.49 to 49.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (BF1266) IgG-t Ab at W16
|
93.2 percentage of responders
Interval 81.34 to 98.57
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
C Clade C (BF1266) IgG-t Ab at W28
|
95.7 percentage of responders
Interval 85.16 to 99.47
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
97.7 percentage of responders
Interval 87.71 to 99.94
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
92.9 percentage of responders
Interval 80.52 to 98.5
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W52
|
95.6 percentage of responders
Interval 84.85 to 99.46
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
61.9 percentage of responders
Interval 45.64 to 76.43
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
80.5 percentage of responders
Interval 65.13 to 91.18
|
94.4 percentage of responders
Interval 81.34 to 99.32
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W28
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
0 percentage of responders
Interval 0.0 to 7.71
|
4.7 percentage of responders
Interval 0.57 to 15.81
|
2.3 percentage of responders
Interval 0.06 to 12.02
|
2.4 percentage of responders
Interval 0.06 to 12.86
|
2.3 percentage of responders
Interval 0.06 to 12.29
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W28
|
0 percentage of responders
Interval 0.0 to 7.4
|
2.5 percentage of responders
Interval 0.06 to 13.16
|
0 percentage of responders
Interval 0.0 to 7.71
|
0 percentage of responders
Interval 0.0 to 8.22
|
2.4 percentage of responders
Interval 0.06 to 12.57
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W52
|
0 percentage of responders
Interval 0.0 to 7.87
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W16
|
61.7 percentage of responders
Interval 46.38 to 75.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W28
|
75.0 percentage of responders
Interval 60.4 to 86.36
|
47.5 percentage of responders
Interval 31.51 to 63.87
|
34.8 percentage of responders
Interval 21.35 to 50.25
|
76.7 percentage of responders
Interval 61.37 to 88.24
|
79.1 percentage of responders
Interval 63.96 to 89.96
|
58.5 percentage of responders
Interval 42.11 to 73.68
|
67.4 percentage of responders
Interval 51.46 to 80.92
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W52
|
76.7 percentage of responders
Interval 61.37 to 88.24
|
59.5 percentage of responders
Interval 42.1 to 75.25
|
56.1 percentage of responders
Interval 39.75 to 71.53
|
78.9 percentage of responders
Interval 62.68 to 90.45
|
82.1 percentage of responders
Interval 66.47 to 92.46
|
48.8 percentage of responders
Interval 32.88 to 64.87
|
81.1 percentage of responders
Interval 64.84 to 92.04
|
7.7 percentage of responders
Interval 1.62 to 20.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W78
|
53.5 percentage of responders
Interval 37.65 to 68.82
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W96
|
48.8 percentage of responders
Interval 32.88 to 64.87
|
34.3 percentage of responders
Interval 19.13 to 52.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W16
|
31.9 percentage of responders
Interval 19.09 to 47.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W28
|
31.3 percentage of responders
Interval 18.66 to 46.25
|
22.5 percentage of responders
Interval 10.84 to 38.45
|
10.9 percentage of responders
Interval 3.62 to 23.57
|
32.6 percentage of responders
Interval 19.08 to 48.54
|
23.3 percentage of responders
Interval 11.76 to 38.63
|
22.0 percentage of responders
Interval 10.56 to 37.61
|
11.6 percentage of responders
Interval 3.89 to 25.08
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W52
|
48.8 percentage of responders
Interval 33.31 to 64.54
|
27.0 percentage of responders
Interval 13.79 to 44.12
|
17.1 percentage of responders
Interval 7.15 to 32.06
|
47.4 percentage of responders
Interval 30.98 to 64.18
|
46.2 percentage of responders
Interval 30.09 to 62.82
|
31.7 percentage of responders
Interval 18.08 to 48.09
|
24.3 percentage of responders
Interval 11.77 to 41.2
|
2.6 percentage of responders
Interval 0.06 to 13.48
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W78
|
14.0 percentage of responders
Interval 5.3 to 27.93
|
7.9 percentage of responders
Interval 1.66 to 21.38
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W96
|
17.1 percentage of responders
Interval 7.15 to 32.06
|
8.6 percentage of responders
Interval 1.8 to 23.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG3 Ab at W16
|
25.5 percentage of responders
Interval 13.94 to 40.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG3 Ab at W28
|
52.1 percentage of responders
Interval 37.19 to 66.71
|
45.0 percentage of responders
Interval 29.26 to 61.51
|
13.0 percentage of responders
Interval 4.94 to 26.26
|
55.8 percentage of responders
Interval 39.88 to 70.92
|
58.1 percentage of responders
Interval 42.13 to 72.99
|
26.8 percentage of responders
Interval 14.22 to 42.94
|
46.5 percentage of responders
Interval 31.18 to 62.35
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
43HIV ENV gp41 IgG3 Ab at W52
|
67.4 percentage of responders
Interval 51.46 to 80.92
|
54.1 percentage of responders
Interval 36.92 to 70.51
|
14.6 percentage of responders
Interval 5.57 to 29.17
|
73.7 percentage of responders
Interval 56.9 to 86.6
|
79.5 percentage of responders
Interval 63.54 to 90.7
|
26.8 percentage of responders
Interval 14.22 to 42.94
|
67.6 percentage of responders
Interval 50.21 to 81.99
|
7.7 percentage of responders
Interval 1.62 to 20.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG3 Ab at W78
|
34.9 percentage of responders
Interval 21.01 to 50.93
|
23.7 percentage of responders
Interval 11.44 to 40.24
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG3 Ab at W96
|
31.7 percentage of responders
Interval 18.08 to 48.09
|
22.9 percentage of responders
Interval 10.42 to 40.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W16
|
68.1 percentage of responders
Interval 52.88 to 80.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W28
|
66.7 percentage of responders
Interval 51.59 to 79.6
|
50.0 percentage of responders
Interval 33.8 to 66.2
|
39.1 percentage of responders
Interval 25.09 to 54.63
|
65.1 percentage of responders
Interval 49.07 to 78.99
|
65.1 percentage of responders
Interval 49.07 to 78.99
|
58.5 percentage of responders
Interval 42.11 to 73.68
|
53.5 percentage of responders
Interval 37.65 to 68.82
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W52
|
76.7 percentage of responders
Interval 61.37 to 88.24
|
67.6 percentage of responders
Interval 50.21 to 81.99
|
51.2 percentage of responders
Interval 35.13 to 67.12
|
78.9 percentage of responders
Interval 62.68 to 90.45
|
82.1 percentage of responders
Interval 66.47 to 92.46
|
58.5 percentage of responders
Interval 42.11 to 73.68
|
75.7 percentage of responders
Interval 58.8 to 88.23
|
2.6 percentage of responders
Interval 0.06 to 13.48
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W78
|
53.5 percentage of responders
Interval 37.65 to 68.82
|
39.5 percentage of responders
Interval 24.04 to 56.61
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W96
|
48.8 percentage of responders
Interval 32.88 to 64.87
|
37.1 percentage of responders
Interval 21.47 to 55.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W16
|
74.5 percentage of responders
Interval 59.65 to 86.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W28
|
83.3 percentage of responders
Interval 69.78 to 92.52
|
60.0 percentage of responders
Interval 43.33 to 75.14
|
67.4 percentage of responders
Interval 51.98 to 80.47
|
86.0 percentage of responders
Interval 72.07 to 94.7
|
86.0 percentage of responders
Interval 72.07 to 94.7
|
75.6 percentage of responders
Interval 59.7 to 87.64
|
76.7 percentage of responders
Interval 61.37 to 88.24
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W52
|
81.4 percentage of responders
Interval 66.6 to 91.61
|
70.3 percentage of responders
Interval 53.02 to 84.13
|
65.9 percentage of responders
Interval 49.41 to 79.92
|
86.8 percentage of responders
Interval 71.91 to 95.59
|
87.2 percentage of responders
Interval 72.57 to 95.7
|
61.0 percentage of responders
Interval 44.5 to 75.8
|
83.8 percentage of responders
Interval 67.99 to 93.81
|
2.6 percentage of responders
Interval 0.06 to 13.48
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W78
|
55.8 percentage of responders
Interval 39.88 to 70.92
|
36.8 percentage of responders
Interval 21.81 to 54.01
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W96
|
46.3 percentage of responders
Interval 30.66 to 62.58
|
31.4 percentage of responders
Interval 16.85 to 49.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W16
|
12.8 percentage of responders
Interval 4.83 to 25.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W28
|
18.8 percentage of responders
Interval 8.95 to 32.63
|
12.5 percentage of responders
Interval 4.19 to 26.8
|
6.5 percentage of responders
Interval 1.37 to 17.9
|
23.3 percentage of responders
Interval 11.76 to 38.63
|
16.3 percentage of responders
Interval 6.81 to 30.7
|
14.6 percentage of responders
Interval 5.57 to 29.17
|
16.3 percentage of responders
Interval 6.81 to 30.7
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W52
|
25.6 percentage of responders
Interval 13.52 to 41.17
|
10.8 percentage of responders
Interval 3.03 to 25.42
|
9.8 percentage of responders
Interval 2.72 to 23.13
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
15.4 percentage of responders
Interval 5.86 to 30.53
|
9.8 percentage of responders
Interval 2.72 to 23.13
|
16.2 percentage of responders
Interval 6.19 to 32.01
|
2.6 percentage of responders
Interval 0.06 to 13.48
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W78
|
4.7 percentage of responders
Interval 0.57 to 15.81
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W96
|
9.8 percentage of responders
Interval 2.72 to 23.13
|
8.6 percentage of responders
Interval 1.8 to 23.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W16
|
14.9 percentage of responders
Interval 6.2 to 28.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W52
|
18.6 percentage of responders
Interval 8.39 to 33.4
|
10.8 percentage of responders
Interval 3.03 to 25.42
|
5.0 percentage of responders
Interval 0.61 to 16.92
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
7.7 percentage of responders
Interval 1.62 to 20.87
|
7.5 percentage of responders
Interval 1.57 to 20.39
|
10.8 percentage of responders
Interval 3.03 to 25.42
|
2.6 percentage of responders
Interval 0.06 to 13.48
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W78
|
2.3 percentage of responders
Interval 0.06 to 12.29
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W96
|
2.4 percentage of responders
Interval 0.06 to 12.86
|
2.9 percentage of responders
Interval 0.07 to 14.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W16
|
10.4 percentage of responders
Interval 3.47 to 22.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W52
|
40.0 percentage of responders
Interval 25.7 to 55.67
|
29.7 percentage of responders
Interval 15.87 to 46.98
|
19.0 percentage of responders
Interval 8.6 to 34.12
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
20.0 percentage of responders
Interval 9.05 to 35.65
|
12.2 percentage of responders
Interval 4.08 to 26.2
|
35.1 percentage of responders
Interval 20.21 to 52.54
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W52
|
15.6 percentage of responders
Interval 6.49 to 29.46
|
10.8 percentage of responders
Interval 3.03 to 25.42
|
2.4 percentage of responders
Interval 0.06 to 12.57
|
18.4 percentage of responders
Interval 7.74 to 34.33
|
5.0 percentage of responders
Interval 0.61 to 16.92
|
0 percentage of responders
Interval 0.0 to 8.6
|
8.1 percentage of responders
Interval 1.7 to 21.91
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG4 Ab at W16
|
10.4 percentage of responders
Interval 3.47 to 22.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG4 Ab at W28
|
33.3 percentage of responders
Interval 20.4 to 48.41
|
15.0 percentage of responders
Interval 5.71 to 29.84
|
13.0 percentage of responders
Interval 4.94 to 26.26
|
25.6 percentage of responders
Interval 13.52 to 41.17
|
20.5 percentage of responders
Interval 9.8 to 35.3
|
7.3 percentage of responders
Interval 1.54 to 19.92
|
34.9 percentage of responders
Interval 21.01 to 50.93
|
2.2 percentage of responders
Interval 0.06 to 11.77
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG4 Ab at W52
|
66.7 percentage of responders
Interval 51.05 to 80.0
|
56.8 percentage of responders
Interval 39.49 to 72.9
|
16.7 percentage of responders
Interval 6.97 to 31.36
|
52.6 percentage of responders
Interval 35.82 to 69.02
|
45.0 percentage of responders
Interval 29.26 to 61.51
|
7.3 percentage of responders
Interval 1.54 to 19.92
|
62.2 percentage of responders
Interval 44.76 to 77.54
|
7.3 percentage of responders
Interval 1.54 to 19.92
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W16
|
10.4 percentage of responders
Interval 3.47 to 22.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W28
|
14.6 percentage of responders
Interval 6.07 to 27.76
|
7.5 percentage of responders
Interval 1.57 to 20.39
|
6.5 percentage of responders
Interval 1.37 to 17.9
|
9.3 percentage of responders
Interval 2.59 to 22.14
|
6.8 percentage of responders
Interval 1.43 to 18.66
|
9.8 percentage of responders
Interval 2.72 to 23.13
|
14.0 percentage of responders
Interval 5.3 to 27.93
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W52
|
31.1 percentage of responders
Interval 18.17 to 46.65
|
21.6 percentage of responders
Interval 9.83 to 38.21
|
9.5 percentage of responders
Interval 2.66 to 22.62
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
20.0 percentage of responders
Interval 9.05 to 35.65
|
12.2 percentage of responders
Interval 4.08 to 26.2
|
27.0 percentage of responders
Interval 13.79 to 44.12
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W16
|
12.5 percentage of responders
Interval 4.73 to 25.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W28
|
18.8 percentage of responders
Interval 8.95 to 32.63
|
12.5 percentage of responders
Interval 4.19 to 26.8
|
10.9 percentage of responders
Interval 3.62 to 23.57
|
9.3 percentage of responders
Interval 2.59 to 22.14
|
13.6 percentage of responders
Interval 5.17 to 27.35
|
9.8 percentage of responders
Interval 2.72 to 23.13
|
16.3 percentage of responders
Interval 6.81 to 30.7
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W52
|
46.7 percentage of responders
Interval 31.66 to 62.13
|
35.1 percentage of responders
Interval 20.21 to 52.54
|
16.7 percentage of responders
Interval 6.97 to 31.36
|
28.9 percentage of responders
Interval 15.42 to 45.9
|
40.0 percentage of responders
Interval 24.86 to 56.67
|
22.0 percentage of responders
Interval 10.56 to 37.61
|
37.8 percentage of responders
Interval 22.46 to 55.24
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W16
|
14.9 percentage of responders
Interval 6.2 to 28.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W28
|
60.4 percentage of responders
Interval 45.27 to 74.23
|
40.5 percentage of responders
Interval 24.75 to 57.9
|
15.2 percentage of responders
Interval 6.34 to 28.87
|
59.1 percentage of responders
Interval 43.25 to 73.66
|
39.0 percentage of responders
Interval 24.2 to 55.5
|
39.0 percentage of responders
Interval 24.2 to 55.5
|
23.3 percentage of responders
Interval 11.76 to 38.63
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W52
|
60.0 percentage of responders
Interval 44.33 to 74.3
|
44.1 percentage of responders
Interval 27.19 to 62.11
|
11.9 percentage of responders
Interval 3.98 to 25.63
|
62.5 percentage of responders
Interval 45.8 to 77.27
|
35.1 percentage of responders
Interval 20.21 to 52.54
|
19.5 percentage of responders
Interval 8.82 to 34.87
|
22.2 percentage of responders
Interval 10.12 to 39.15
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG1 Ab at W16
|
59.6 percentage of responders
Interval 44.27 to 73.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG1 Ab at W28
|
95.8 percentage of responders
Interval 85.75 to 99.49
|
94.6 percentage of responders
Interval 81.81 to 99.34
|
78.3 percentage of responders
Interval 63.64 to 89.05
|
90.9 percentage of responders
Interval 78.33 to 97.47
|
97.6 percentage of responders
Interval 87.14 to 99.94
|
82.9 percentage of responders
Interval 67.94 to 92.85
|
95.3 percentage of responders
Interval 84.19 to 99.43
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG1 Ab at W52
|
95.6 percentage of responders
Interval 84.85 to 99.46
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
61.9 percentage of responders
Interval 45.64 to 76.43
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
97.3 percentage of responders
Interval 85.84 to 99.93
|
68.3 percentage of responders
Interval 51.91 to 81.92
|
97.2 percentage of responders
Interval 85.47 to 99.93
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W16
|
40.4 percentage of responders
Interval 26.37 to 55.73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W28
|
85.4 percentage of responders
Interval 72.24 to 93.93
|
70.3 percentage of responders
Interval 53.02 to 84.13
|
56.5 percentage of responders
Interval 41.11 to 71.07
|
79.5 percentage of responders
Interval 64.7 to 90.2
|
87.8 percentage of responders
Interval 73.8 to 95.92
|
70.7 percentage of responders
Interval 54.46 to 83.87
|
72.1 percentage of responders
Interval 56.33 to 84.67
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W52
|
80.0 percentage of responders
Interval 65.4 to 90.42
|
79.4 percentage of responders
Interval 62.1 to 91.3
|
35.7 percentage of responders
Interval 21.55 to 51.97
|
82.5 percentage of responders
Interval 67.22 to 92.66
|
83.8 percentage of responders
Interval 67.99 to 93.81
|
46.3 percentage of responders
Interval 30.66 to 62.58
|
83.3 percentage of responders
Interval 67.19 to 93.63
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W16
|
74.5 percentage of responders
Interval 59.65 to 86.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W28
|
93.8 percentage of responders
Interval 82.8 to 98.69
|
94.6 percentage of responders
Interval 81.81 to 99.34
|
76.1 percentage of responders
Interval 61.23 to 87.41
|
90.9 percentage of responders
Interval 78.33 to 97.47
|
100.0 percentage of responders
Interval 91.4 to 100.0
|
100.0 percentage of responders
Interval 91.4 to 100.0
|
86.0 percentage of responders
Interval 72.07 to 94.7
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W52
|
95.6 percentage of responders
Interval 84.85 to 99.46
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
76.2 percentage of responders
Interval 60.55 to 87.95
|
92.5 percentage of responders
Interval 79.61 to 98.43
|
97.3 percentage of responders
Interval 85.84 to 99.93
|
90.2 percentage of responders
Interval 76.87 to 97.28
|
94.4 percentage of responders
Interval 81.34 to 99.32
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W16
|
6.4 percentage of responders
Interval 1.34 to 17.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W28
|
16.7 percentage of responders
Interval 7.48 to 30.22
|
10.8 percentage of responders
Interval 3.03 to 25.42
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
18.2 percentage of responders
Interval 8.19 to 32.71
|
19.5 percentage of responders
Interval 8.82 to 34.87
|
4.9 percentage of responders
Interval 0.6 to 16.53
|
7.0 percentage of responders
Interval 1.46 to 19.06
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W52
|
20.0 percentage of responders
Interval 9.58 to 34.6
|
8.8 percentage of responders
Interval 1.86 to 23.68
|
4.8 percentage of responders
Interval 0.58 to 16.16
|
25.0 percentage of responders
Interval 12.69 to 41.2
|
13.5 percentage of responders
Interval 4.54 to 28.77
|
9.8 percentage of responders
Interval 2.72 to 23.13
|
13.9 percentage of responders
Interval 4.67 to 29.5
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W16
|
14.9 percentage of responders
Interval 6.2 to 28.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W28
|
29.2 percentage of responders
Interval 16.95 to 44.06
|
27.0 percentage of responders
Interval 13.79 to 44.12
|
10.9 percentage of responders
Interval 3.62 to 23.57
|
20.5 percentage of responders
Interval 9.8 to 35.3
|
22.0 percentage of responders
Interval 10.56 to 37.61
|
7.3 percentage of responders
Interval 1.54 to 19.92
|
7.0 percentage of responders
Interval 1.46 to 19.06
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W52
|
13.3 percentage of responders
Interval 5.05 to 26.79
|
14.7 percentage of responders
Interval 4.95 to 31.06
|
9.5 percentage of responders
Interval 2.66 to 22.62
|
22.5 percentage of responders
Interval 10.84 to 38.45
|
13.5 percentage of responders
Interval 4.54 to 28.77
|
0 percentage of responders
Interval 0.0 to 8.6
|
13.9 percentage of responders
Interval 4.67 to 29.5
|
2.4 percentage of responders
Interval 0.06 to 12.86
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W28
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 7.71
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W52
|
2.2 percentage of responders
Interval 0.06 to 11.77
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W28
|
0 percentage of responders
Interval 0.0 to 7.4
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 7.71
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W52
|
0 percentage of responders
Interval 0.0 to 7.87
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG2 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG2 Ab at W28
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 7.71
|
2.3 percentage of responders
Interval 0.06 to 12.29
|
2.4 percentage of responders
Interval 0.06 to 12.57
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp41 IgG2 Ab at W52
|
0 percentage of responders
Interval 0.0 to 7.87
|
2.7 percentage of responders
Interval 0.07 to 14.16
|
0 percentage of responders
Interval 0.0 to 8.41
|
5.0 percentage of responders
Interval 0.61 to 16.92
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W16
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W28
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 7.71
|
2.3 percentage of responders
Interval 0.06 to 12.29
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W52
|
0 percentage of responders
Interval 0.0 to 7.87
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W16
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W28
|
2.1 percentage of responders
Interval 0.05 to 11.07
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 7.71
|
2.3 percentage of responders
Interval 0.06 to 12.29
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W28
|
0 percentage of responders
Interval 0.0 to 7.4
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 7.71
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 8.22
|
0 percentage of responders
Interval 0.0 to 7.87
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W52
|
0 percentage of responders
Interval 0.0 to 7.87
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.41
|
0 percentage of responders
Interval 0.0 to 8.81
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
0 percentage of responders
Interval 0.0 to 9.49
|
0 percentage of responders
Interval 0.0 to 8.6
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W16
|
0 percentage of responders
Interval 0.0 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
B Clade M (Con 6) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
97.4 percentage of responders
Interval 86.52 to 99.94
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
B Clade M (Con 6) IgG-t Ab at W78
|
97.4 percentage of responders
Interval 86.52 to 99.94
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
B Clade M (Con 6) IgG-t Ab at W96
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
93.5 percentage of responders
Interval 78.58 to 99.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (SC42261) IgG-t Ab at W16
|
95.5 percentage of responders
Interval 84.53 to 99.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (SC42261) IgG-t Ab at W28
|
97.8 percentage of responders
Interval 88.47 to 99.94
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
95.0 percentage of responders
Interval 83.08 to 99.39
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
95.2 percentage of responders
Interval 83.84 to 99.42
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade A (51802) IgG-t Ab at W78
|
79.5 percentage of responders
Interval 63.54 to 90.7
|
81.8 percentage of responders
Interval 64.54 to 93.02
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W16
|
67.5 percentage of responders
Interval 50.87 to 81.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (BORI) IgG-t Ab at W16
|
95.5 percentage of responders
Interval 84.53 to 99.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (BORI) IgG-t Ab at W78
|
84.6 percentage of responders
Interval 69.47 to 94.14
|
84.8 percentage of responders
Interval 68.1 to 94.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade B (TT31P) gp120 IgG-t Ab at W16
|
90.9 percentage of responders
Interval 78.33 to 97.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (CNE20) IgG-t Ab at W16
|
90.9 percentage of responders
Interval 78.33 to 97.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (CNE20) IgG-t Ab at W52
|
100.0 percentage of responders
Interval 90.51 to 100.0
|
100.0 percentage of responders
Interval 89.11 to 100.0
|
97.4 percentage of responders
Interval 86.52 to 99.94
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
94.7 percentage of responders
Interval 82.25 to 99.36
|
93.9 percentage of responders
Interval 79.77 to 99.26
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC (CNE20) IgG-t Ab at W96
|
78.9 percentage of responders
Interval 62.68 to 90.45
|
87.1 percentage of responders
Interval 70.17 to 96.37
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC(BJOX002) IgG-t Ab at W16
|
75.0 percentage of responders
Interval 59.66 to 86.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade BC(BJOX002) IgG-t Ab at W78
|
74.4 percentage of responders
Interval 57.87 to 86.96
|
75.8 percentage of responders
Interval 57.74 to 88.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(1086C_D7) IgG-t Ab at W16
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(1086C_D7) IgG-t Ab at W28
|
100.0 percentage of responders
Interval 92.29 to 100.0
|
97.1 percentage of responders
Interval 85.08 to 99.93
|
100.0 percentage of responders
Interval 91.78 to 100.0
|
97.5 percentage of responders
Interval 86.84 to 99.94
|
88.6 percentage of responders
Interval 73.26 to 96.8
|
100.0 percentage of responders
Interval 90.75 to 100.0
|
90.75 percentage of responders
Interval 83.84 to 99.42
|
0 percentage of responders
Interval 0.0 to 8.81
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(1086C_D7) IgG-t Ab at W78
|
100.0 percentage of responders
Interval 90.97 to 100.0
|
100.0 percentage of responders
Interval 89.42 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Clade C(1086C_D7) IgG-t Ab at Week 96
|
97.4 percentage of responders
Interval 86.19 to 99.93
|
96.8 percentage of responders
Interval 83.3 to 99.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
B Clade M (Con 6) IgG-t Ab at W16
|
97.7 percentage of responders
Interval 87.98 to 99.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26, 50, 78 and 96Population: PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Outcome measures
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=47 Participants
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=39 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=45 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=44 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=43 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=38 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=43 Participants
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate).
|
Group 8: Placebo/ Placebo
n=46 Participants
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool Mos1 at W 26
|
44.7 percentage of responders
Interval 30.17 to 59.88
|
38.5 percentage of responders
Interval 23.36 to 55.38
|
36.4 percentage of responders
Interval 22.41 to 52.23
|
54.5 percentage of responders
Interval 38.85 to 69.61
|
55.8 percentage of responders
Interval 39.88 to 70.92
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
34.9 percentage of responders
Interval 21.01 to 50.93
|
0 percentage of responders
Interval 0.0 to 7.71
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool PTE at W 50
|
80.5 percentage of responders
Interval 65.13 to 91.18
|
63.2 percentage of responders
Interval 45.99 to 78.19
|
58.5 percentage of responders
Interval 42.11 to 73.68
|
79.5 percentage of responders
Interval 63.54 to 90.7
|
88.2 percentage of responders
Interval 72.55 to 96.7
|
81.1 percentage of responders
Interval 64.84 to 92.04
|
67.6 percentage of responders
Interval 49.47 to 82.61
|
0 percentage of responders
Interval 0.0 to 9.25
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool PTE at W 78
|
61.0 percentage of responders
Interval 44.5 to 75.8
|
50.0 percentage of responders
Interval 32.92 to 67.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool PTE at W 96
|
64.1 percentage of responders
Interval 47.18 to 78.8
|
40.6 percentage of responders
Interval 23.7 to 59.36
|
40.0 percentage of responders
Interval 21.13 to 61.33
|
50.0 percentage of responders
Interval 28.22 to 71.78
|
73.9 percentage of responders
Interval 51.59 to 89.77
|
62.5 percentage of responders
Interval 40.59 to 81.2
|
47.6 percentage of responders
Interval 25.71 to 70.22
|
—
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool Mos1 at W 50
|
46.3 percentage of responders
Interval 30.66 to 62.58
|
47.4 percentage of responders
Interval 30.98 to 64.18
|
24.4 percentage of responders
Interval 12.36 to 40.3
|
61.5 percentage of responders
Interval 44.62 to 76.64
|
73.5 percentage of responders
Interval 55.64 to 87.12
|
61.1 percentage of responders
Interval 43.46 to 76.86
|
23.5 percentage of responders
Interval 10.75 to 41.17
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool Mos2 at W 26
|
48.9 percentage of responders
Interval 34.08 to 63.94
|
35.9 percentage of responders
Interval 21.2 to 52.82
|
43.2 percentage of responders
Interval 28.35 to 58.97
|
56.8 percentage of responders
Interval 41.03 to 71.65
|
55.8 percentage of responders
Interval 39.88 to 70.92
|
68.4 percentage of responders
Interval 51.35 to 82.5
|
39.5 percentage of responders
Interval 24.98 to 55.59
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool Mos2 at W 50
|
59.0 percentage of responders
Interval 42.1 to 74.43
|
47.1 percentage of responders
Interval 29.78 to 64.87
|
35.0 percentage of responders
Interval 20.63 to 51.68
|
71.1 percentage of responders
Interval 54.1 to 84.58
|
78.8 percentage of responders
Interval 61.09 to 91.02
|
66.7 percentage of responders
Interval 49.03 to 81.44
|
43.3 percentage of responders
Interval 25.46 to 62.57
|
0 percentage of responders
Interval 0.0 to 10.0
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool PTE at W 26
|
38.3 percentage of responders
Interval 24.51 to 53.62
|
30.8 percentage of responders
Interval 17.02 to 47.57
|
38.6 percentage of responders
Interval 24.36 to 54.5
|
47.7 percentage of responders
Interval 32.46 to 63.31
|
55.8 percentage of responders
Interval 39.88 to 70.92
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
30.2 percentage of responders
Interval 17.18 to 46.13
|
0 percentage of responders
Interval 0.0 to 7.71
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool PTE at W 50
|
43.6 percentage of responders
Interval 27.81 to 60.38
|
47.2 percentage of responders
Interval 30.41 to 64.51
|
34.1 percentage of responders
Interval 20.08 to 50.59
|
50.0 percentage of responders
Interval 33.38 to 66.62
|
64.7 percentage of responders
Interval 46.49 to 80.25
|
63.9 percentage of responders
Interval 46.22 to 79.18
|
21.9 percentage of responders
Interval 9.28 to 39.97
|
5.6 percentage of responders
Interval 0.68 to 18.66
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool PTE at W 96
|
20.5 percentage of responders
Interval 9.3 to 36.46
|
25.0 percentage of responders
Interval 11.46 to 43.4
|
20.0 percentage of responders
Interval 6.83 to 40.7
|
27.3 percentage of responders
Interval 10.73 to 50.22
|
30.4 percentage of responders
Interval 13.21 to 52.92
|
33.3 percentage of responders
Interval 15.63 to 55.32
|
23.8 percentage of responders
Interval 8.22 to 47.17
|
—
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool Mos2 at W 50
|
84.6 percentage of responders
Interval 69.47 to 94.14
|
70.6 percentage of responders
Interval 52.52 to 84.9
|
79.5 percentage of responders
Interval 63.54 to 90.7
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
97.0 percentage of responders
Interval 84.24 to 99.92
|
100.0 percentage of responders
Interval 90.26 to 100.0
|
55.2 percentage of responders
Interval 35.69 to 73.55
|
0 percentage of responders
Interval 0.0 to 10.0
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool PTE at W 78
|
78.0 percentage of responders
Interval 62.39 to 89.44
|
52.8 percentage of responders
Interval 35.49 to 69.59
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool PTE at W 96
|
71.8 percentage of responders
Interval 55.13 to 85.0
|
40.6 percentage of responders
Interval 23.7 to 59.36
|
60.0 percentage of responders
Interval 38.67 to 78.87
|
36.4 percentage of responders
Interval 17.2 to 59.34
|
56.5 percentage of responders
Interval 34.49 to 76.81
|
62.5 percentage of responders
Interval 40.59 to 81.2
|
33.3 percentage of responders
Interval 14.59 to 56.97
|
—
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Gag peptide pool PTE at W 78
|
29.3 percentage of responders
Interval 16.13 to 45.54
|
33.3 percentage of responders
Interval 18.56 to 50.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool PTE at W 50
|
82.1 percentage of responders
Interval 66.47 to 92.46
|
54.3 percentage of responders
Interval 36.65 to 71.17
|
73.2 percentage of responders
Interval 57.06 to 85.78
|
86.8 percentage of responders
Interval 71.91 to 95.59
|
90.9 percentage of responders
Interval 75.67 to 98.08
|
94.4 percentage of responders
Interval 81.34 to 99.32
|
53.1 percentage of responders
Interval 34.74 to 70.91
|
0 percentage of responders
Interval 0.0 to 9.74
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool Mos1 at Week (W) 26
|
91.5 percentage of responders
Interval 79.62 to 97.63
|
79.5 percentage of responders
Interval 63.54 to 90.7
|
75.0 percentage of responders
Interval 59.66 to 86.81
|
95.5 percentage of responders
Interval 84.53 to 99.44
|
97.7 percentage of responders
Interval 87.71 to 99.94
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
86.0 percentage of responders
Interval 72.07 to 94.7
|
4.3 percentage of responders
Interval 0.53 to 14.84
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool Mos1 at W 50
|
87.8 percentage of responders
Interval 73.8 to 95.92
|
84.2 percentage of responders
Interval 68.75 to 93.98
|
78.0 percentage of responders
Interval 62.39 to 89.44
|
94.9 percentage of responders
Interval 82.68 to 99.37
|
97.1 percentage of responders
Interval 84.67 to 99.93
|
97.3 percentage of responders
Interval 85.84 to 99.93
|
76.5 percentage of responders
Interval 58.83 to 89.25
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool Mos2 at W 26
|
72.3 percentage of responders
Interval 57.36 to 84.38
|
41.0 percentage of responders
Interval 25.57 to 57.9
|
34.1 percentage of responders
Interval 20.49 to 49.92
|
72.7 percentage of responders
Interval 57.21 to 85.04
|
72.1 percentage of responders
Interval 56.33 to 84.67
|
71.1 percentage of responders
Interval 54.1 to 84.58
|
53.5 percentage of responders
Interval 37.65 to 68.82
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool Mos2 at W 50
|
84.6 percentage of responders
Interval 69.47 to 94.14
|
62.9 percentage of responders
Interval 44.92 to 78.53
|
37.5 percentage of responders
Interval 22.73 to 54.2
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
87.9 percentage of responders
Interval 71.8 to 96.6
|
80.6 percentage of responders
Interval 63.98 to 91.81
|
60.0 percentage of responders
Interval 40.6 to 77.34
|
2.8 percentage of responders
Interval 0.07 to 14.53
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
ENV peptide pool potential T-cell epitopes(PTE)W26
|
76.6 percentage of responders
Interval 61.97 to 87.7
|
59.0 percentage of responders
Interval 42.1 to 74.43
|
61.4 percentage of responders
Interval 45.5 to 75.64
|
72.7 percentage of responders
Interval 57.21 to 85.04
|
93.0 percentage of responders
Interval 80.94 to 98.54
|
81.6 percentage of responders
Interval 65.67 to 92.26
|
69.8 percentage of responders
Interval 53.87 to 82.82
|
2.2 percentage of responders
Interval 0.06 to 11.53
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool Mos1 at W 26
|
80.9 percentage of responders
Interval 66.74 to 90.85
|
53.8 percentage of responders
Interval 37.18 to 69.91
|
56.8 percentage of responders
Interval 41.03 to 71.65
|
70.5 percentage of responders
Interval 54.8 to 83.24
|
81.4 percentage of responders
Interval 66.6 to 91.61
|
89.5 percentage of responders
Interval 75.2 to 97.06
|
58.1 percentage of responders
Interval 42.13 to 72.99
|
4.3 percentage of responders
Interval 0.53 to 14.84
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool Mos1 at W 50
|
72.5 percentage of responders
Interval 56.11 to 85.4
|
55.6 percentage of responders
Interval 38.1 to 72.06
|
65.9 percentage of responders
Interval 49.41 to 79.92
|
76.3 percentage of responders
Interval 59.76 to 88.56
|
85.3 percentage of responders
Interval 68.94 to 95.05
|
91.7 percentage of responders
Interval 77.53 to 98.25
|
39.4 percentage of responders
Interval 22.91 to 57.86
|
2.6 percentage of responders
Interval 0.07 to 13.81
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool Mos2 at W 26
|
85.1 percentage of responders
Interval 71.69 to 93.8
|
76.9 percentage of responders
Interval 60.67 to 88.87
|
68.2 percentage of responders
Interval 52.42 to 81.39
|
79.5 percentage of responders
Interval 64.7 to 90.2
|
86.0 percentage of responders
Interval 72.07 to 94.7
|
94.7 percentage of responders
Interval 82.25 to 99.36
|
69.8 percentage of responders
Interval 53.87 to 82.82
|
0 percentage of responders
Interval 0.0 to 7.71
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Pol peptide pool PTE at W 26
|
83.0 percentage of responders
Interval 69.19 to 92.35
|
56.4 percentage of responders
Interval 39.62 to 72.19
|
61.4 percentage of responders
Interval 45.5 to 75.64
|
68.2 percentage of responders
Interval 52.42 to 81.39
|
86.0 percentage of responders
Interval 72.07 to 94.7
|
92.1 percentage of responders
Interval 78.62 to 98.34
|
67.4 percentage of responders
Interval 51.46 to 80.92
|
0 percentage of responders
Interval 0.0 to 7.71
|
Adverse Events
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Serious events: 8 serious events
Other events: 40 other events
Deaths: 0 deaths
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Group 3: Ad26/Ad26
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Group 4: Ad26/MVA + gp140 HD
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Group 5: Ad26/ MVA + gp140 LD
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Group 6: Ad26/MVA
Serious events: 5 serious events
Other events: 41 other events
Deaths: 0 deaths
Group 7: Ad26/ gp140 HD
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Group 8: Placebo/ Placebo
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=50 participants at risk
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=48 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=50 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
|
Group 8: Placebo/ Placebo
n=49 participants at risk
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Local Swelling
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Corona Virus Infection
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Hiv Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Tonsillitis Bacterial
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Tubo-Ovarian Abscess
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted Ovum
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Pregnancy, puerperium and perinatal conditions
Complication of Pregnancy
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal Death
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal Disorder
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Adjustment Disorder
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Generalised Anxiety Disorder
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Social circumstances
Miscarriage of Partner
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Social circumstances
Pregnancy of Partner
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
Other adverse events
| Measure |
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
n=50 participants at risk
Participants received 5\*10\^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension (LTE) phase after Week 96 up to Week 336.
|
Group 3: Ad26/Ad26
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5\*10\^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine.
|
Group 4: Ad26/MVA + gp140 HD
n=48 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 5: Ad26/ MVA + gp140 LD
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant.
|
Group 6: Ad26/MVA
n=49 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10\^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine.
|
Group 7: Ad26/ gp140 HD
n=50 participants at risk
Participants received 5\*10\^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate)
|
Group 8: Placebo/ Placebo
n=49 participants at risk
Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.0%
4/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Cardiac disorders
Conduction Disorder
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Endocrine disorders
Thyroid Mass
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Blepharitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Eye Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Eye Swelling
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Eyelid Pain
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Hypermetropia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Eye disorders
Photophobia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Dental Caries
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
4/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.0%
4/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Enteritis
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Tongue Dry
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Asthenia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Chest Discomfort
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Chills
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Face Oedema
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Fatigue
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Feeling Cold
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Feeling Hot
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Influenza Like Illness
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Injection Site Bruising
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.2%
5/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Injection Site Haemorrhage
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Injection Site Hypersensitivity
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Injection Site Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Malaise
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Non-Cardiac Chest Pain
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
General disorders
Tenderness
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Immune system disorders
Anaphylactic Reaction
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Immune system disorders
Food Allergy
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Abscess
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Acute Hiv Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Ascariasis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Bacterial Vaginosis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Body Tinea
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Chlamydial Infection
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.0%
3/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Cystitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Dermatitis Infected
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Gastroenteritis
|
6.0%
3/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Genital Herpes Simplex
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Hookworm Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Influenza
|
8.0%
4/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.2%
5/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.4%
5/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.2%
5/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
12.0%
6/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.2%
5/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Malaria
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Oophoritis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Parasitic Gastroenteritis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Pyuria
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Rhinitis
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Syphilis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Tinea Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Tooth Infection
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Trichomoniasis
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Typhoid Fever
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
5/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
12.2%
6/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
12.5%
6/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.2%
5/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
14.3%
7/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
12.0%
6/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
18.4%
9/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Urethritis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Urethritis Chlamydial
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.2%
5/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.4%
5/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Urogenital Trichomoniasis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Varicella
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Viral Infection
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.0%
3/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Infections and infestations
Vulvovaginitis Trichomonal
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Muscle Contusion
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Procedural Headache
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.0%
6/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.0%
3/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.0%
4/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.0%
3/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Creatine Increased
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Creatinine Decreased
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Creatinine Increased
|
6.0%
3/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Pressure Diastolic Increased
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Pressure Systolic
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Blood Urine Present
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Electrocardiogram QT Prolonged
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.2%
3/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Eosinophil Percentage Increased
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Haemoglobin Decreased
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.3%
4/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Neutrophil Count Decreased
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Protein Urine
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
Red Blood Cells Urine
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Investigations
White Blood Cells Urine
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Metabolism and nutrition disorders
Abnormal Loss of Weight
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.0%
3/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.3%
4/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Dizziness Exertional
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Dizziness Postural
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
10.2%
5/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.2%
3/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Affective Disorder
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Psychiatric disorders
Libido Disorder
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.2%
3/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
4/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.2%
3/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
12.0%
6/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.2%
4/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Renal and urinary disorders
Renal Impairment
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Genital Discharge
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Genital Rash
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Genital Ulceration
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Premenstrual Syndrome
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Sinusitis
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.3%
4/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
8.0%
4/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.0%
2/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
6.1%
3/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.2%
2/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Social circumstances
Pregnancy of Partner
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.1%
1/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
4.1%
2/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
|
Vascular disorders
Systolic Hypertension
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/48 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
0.00%
0/50 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
2.0%
1/49 • Serious adverse events (SAEs) were reported up to Week 336 for Group 1 and 2 and up to Week 96 for the other groups (Group 3, Group 4, Group 5, Group 6, Group 7, Group 8). Other adverse events (AEs) were reported for the main study only period up to Week 96 for all the group
The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Participants in Group 1 and 2 who received all 4 vaccinations in main study continued in long-term extension phase after Week 96 up to Week 336.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER