Trial Outcomes & Findings for A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years (NCT NCT01299480)
NCT ID: NCT01299480
Last Updated: 2022-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1714 participants
Primary outcome timeframe
1 month after Injection 4
Results posted on
2022-10-27
Participant Flow
A total of 1714 participants were enrolled in this study. Of these, 1 participant was not randomized but was vaccinated with Saline at Injection 1. This participant was included in safety population and not intent-to-treat population. Participant Flow includes only randomized intent to treat participants.
Participant milestones
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
427
|
430
|
427
|
286
|
143
|
|
Overall Study
COMPLETED
|
385
|
395
|
386
|
261
|
123
|
|
Overall Study
NOT COMPLETED
|
42
|
35
|
41
|
25
|
20
|
Reasons for withdrawal
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Overall Study
No longer willing to participate
|
19
|
17
|
14
|
13
|
10
|
|
Overall Study
Protocol Violation
|
7
|
5
|
8
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
7
|
3
|
4
|
|
Overall Study
Adverse Event
|
6
|
4
|
5
|
4
|
0
|
|
Overall Study
Withdrawal due to pregnancy
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
2
|
1
|
2
|
|
Overall Study
Other
|
3
|
2
|
3
|
0
|
3
|
|
Overall Study
Started, but not vaccinated
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years
Baseline characteristics by cohort
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=427 Participants
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=430 Participants
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
n=427 Participants
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
n=286 Participants
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
n=143 Participants
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
Total
n=1713 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
11- less than (<) 14 years
|
156 participants
n=5 Participants
|
158 participants
n=7 Participants
|
156 participants
n=5 Participants
|
106 participants
n=4 Participants
|
53 participants
n=21 Participants
|
629 participants
n=8 Participants
|
|
Age, Customized
14 - <19 years
|
271 participants
n=5 Participants
|
272 participants
n=7 Participants
|
271 participants
n=5 Participants
|
180 participants
n=4 Participants
|
90 participants
n=21 Participants
|
1084 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
871 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
215 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
842 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1 month after Injection 4Population: The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain.
Outcome measures
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=365 Participants
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=360 Participants
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
PMB80 [A22] 1:8 (N=360, 357)
|
91.7 percentage of participants
|
95.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
PMB2001 [A56] 1:8 (N=362, 359)
|
99.4 percentage of participants
|
98.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
PMB2948 [B24] 1:8 (N=354, 354)
|
89.0 percentage of participants
|
88.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
PMB2707 [B44] 1:8 (N356, 352)
|
88.5 percentage of participants
|
86.1 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Injection 1 up to 1 month after Injection 4Population: Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
Outcome measures
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=426 Participants
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=414 Participants
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
n=451 Participants
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
n=277 Participants
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
n=144 Participants
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Percentage of Participants Reporting At Least 1 Adverse Event (AE)
|
36.9 percentage of participants
|
35.7 percentage of participants
|
35.5 percentage of participants
|
35.7 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: 1 month after Injection 4Population: The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain.
Outcome measures
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=371 Participants
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
PMB80 [A22] 1:8 (N=369)
|
93.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
PMB2001 [A56] 1: 8 (N=370)
|
98.4 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
PMB2948 [B24] 1:8 (N=359)
|
81.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
PMB2707 [B44] 1:8 (N=356)
|
77.5 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4Population: The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain.
Outcome measures
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=365 Participants
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=360 Participants
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
n=371 Participants
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
n=241 Participants
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
n=113 Participants
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Before Inj1: PMB80 [A22]; N=356,352,364,235,108
|
7.1 titer
Interval 6.41 to 7.87
|
6.3 titer
Interval 5.72 to 6.95
|
6.4 titer
Interval 5.84 to 7.02
|
6.4 titer
Interval 5.66 to 7.22
|
6.8 titer
Interval 5.59 to 8.3
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj2: PMB80 [A22]; N=351,345,351,224,110
|
24.4 titer
Interval 21.25 to 27.94
|
10.7 titer
Interval 9.44 to 12.09
|
12.0 titer
Interval 10.58 to 13.6
|
13.3 titer
Interval 11.21 to 15.76
|
7.1 titer
Interval 5.86 to 8.48
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj3: PMB80 [A22]; N=332,344,340,238,102
|
17.7 titer
Interval 15.28 to 20.47
|
32.9 titer
Interval 29.34 to 36.92
|
10.3 titer
Interval 9.09 to 11.68
|
37.1 titer
Interval 32.23 to 42.76
|
16.0 titer
Interval 12.15 to 21.06
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj4: PMB80 [A22]; N=360,357,369,234,111
|
55.1 titer
Interval 48.87 to 62.07
|
56.3 titer
Interval 50.91 to 62.27
|
48.4 titer
Interval 43.45 to 53.86
|
14.2 titer
Interval 12.08 to 16.73
|
39.6 titer
Interval 32.31 to 48.46
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Before Inj1: PMB2001 [A56]; N=350,348,355,231,107
|
6.8 titer
Interval 6.06 to 7.64
|
6.1 titer
Interval 5.54 to 6.77
|
6.7 titer
Interval 6.0 to 7.48
|
6.3 titer
Interval 5.54 to 7.15
|
6.2 titer
Interval 5.1 to 7.47
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj2: PMB2001 [A56]; N=353,329,335,218,102
|
77.3 titer
Interval 68.54 to 87.12
|
17.0 titer
Interval 14.56 to 19.96
|
18.5 titer
Interval 15.81 to 21.63
|
17.7 titer
Interval 14.45 to 21.58
|
6.8 titer
Interval 5.52 to 8.36
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj3: PMB2001 [A56]; N=329,339,320,240,102
|
48.3 titer
Interval 41.96 to 55.5
|
94.6 titer
Interval 84.64 to 105.68
|
15.1 titer
Interval 12.89 to 17.74
|
104.9 titer
Interval 93.16 to 118.05
|
26.8 titer
Interval 19.48 to 36.92
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj4: PMB2001 [A56]; N=362,359,370,228,113
|
152.9 titer
Interval 137.23 to 170.47
|
155.6 titer
Interval 140.39 to 172.38
|
125.6 titer
Interval 112.59 to 140.17
|
26.5 titer
Interval 22.24 to 31.58
|
111.8 titer
Interval 92.73 to 134.9
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Before Inj1: PMB2948 [B24]; N=362,356,369,241,112
|
5.3 titer
Interval 4.93 to 5.75
|
5.1 titer
Interval 4.77 to 5.52
|
5.0 titer
Interval 4.7 to 5.38
|
4.9 titer
Interval 4.49 to 5.24
|
5.1 titer
Interval 4.51 to 5.82
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj2: PMB2948 [B24]; N=344,345,352,223,110
|
13.8 titer
Interval 12.15 to 15.57
|
8.2 titer
Interval 7.38 to 9.21
|
9.2 titer
Interval 8.2 to 10.28
|
9.8 titer
Interval 8.39 to 11.35
|
5.3 titer
Interval 4.7 to 6.08
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj3: PMB2948 [B24]; N=328,337,340,237,102
|
11.0 titer
Interval 9.61 to 12.5
|
14.9 titer
Interval 13.2 to 16.73
|
7.5 titer
Interval 6.75 to 8.35
|
17.7 titer
Interval 15.24 to 20.49
|
12.6 titer
Interval 10.01 to 15.89
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj4: PMB2948 [B24]; N=354,354,359,228,110
|
29.1 titer
Interval 25.88 to 32.66
|
25.6 titer
Interval 23.03 to 28.45
|
20.6 titer
Interval 18.38 to 23.18
|
8.0 titer
Interval 7.01 to 9.24
|
14.7 titer
Interval 12.01 to 18.1
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Before Inj1: PMB2707 [B44]; N=363,357,370,241,113
|
4.4 titer
Interval 4.18 to 4.54
|
4.5 titer
Interval 4.24 to 4.67
|
4.5 titer
Interval 4.26 to 4.7
|
4.6 titer
Interval 4.28 to 4.9
|
4.4 titer
Interval 4.04 to 4.76
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj2: PMB2707 [B44]; N=341,345,349,225,111
|
13.1 titer
Interval 11.29 to 15.11
|
5.5 titer
Interval 5.04 to 6.01
|
5.7 titer
Interval 5.19 to 6.3
|
5.9 titer
Interval 5.19 to 6.74
|
4.4 titer
Interval 4.04 to 4.77
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj3: PMB2707 [B44]; N=333,331,341,234,105
|
8.4 titer
Interval 7.4 to 9.6
|
15.5 titer
Interval 13.51 to 17.87
|
5.2 titer
Interval 4.78 to 5.68
|
19.1 titer
Interval 16.03 to 22.78
|
6.8 titer
Interval 5.45 to 8.55
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
1M aft Inj4: PMB2707 [B44]; N=356,352,356,230,111
|
40.3 titer
Interval 35.16 to 46.11
|
35.0 titer
Interval 30.63 to 39.91
|
22.5 titer
Interval 19.6 to 25.72
|
6.2 titer
Interval 5.52 to 7.07
|
17.8 titer
Interval 14.12 to 22.42
|
SECONDARY outcome
Timeframe: Before Injection 1, 1 Month after Injection 2, 3, 4Population: The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain.
Outcome measures
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=365 Participants
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=360 Participants
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
n=371 Participants
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
n=241 Participants
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
n=113 Participants
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj3:PMB2707[B44]1:8; N=333,331,341,234,105
|
35.4 percentage of participants
|
61.9 percentage of participants
|
12.6 percentage of participants
|
70.1 percentage of participants
|
23.8 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
Before Inj1: PMB80[A22] 1:8; N=356,352,364,235,108
|
28.1 percentage of participants
|
21.9 percentage of participants
|
24.7 percentage of participants
|
22.6 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj2:PMB80[A22]1:8; N=351,345,351,224,110
|
74.6 percentage of participants
|
46.7 percentage of participants
|
51.3 percentage of participants
|
52.2 percentage of participants
|
28.2 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj3:PMB80[A22]1:8; N=332,344,340,238,102
|
63.0 percentage of participants
|
88.7 percentage of participants
|
44.7 percentage of participants
|
90.8 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj4:PMB80[A22]1:8; N=360,357,369,234,111
|
91.7 percentage of participants
|
95.0 percentage of participants
|
93.5 percentage of participants
|
57.7 percentage of participants
|
91.9 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
Before Inj1:PMB2001[A56]1:8; N=350,348,355,231,107
|
20.9 percentage of participants
|
18.7 percentage of participants
|
21.7 percentage of participants
|
19.0 percentage of participants
|
17.8 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj2:PMB2001[A56]1:8; N=353,329,335,218,102
|
96.6 percentage of participants
|
56.2 percentage of participants
|
58.8 percentage of participants
|
56.0 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj3;PMB2001[A56]1:8; N=329,339,320,240,102
|
89.1 percentage of participants
|
97.9 percentage of participants
|
50.6 percentage of participants
|
100.0 percentage of participants
|
67.6 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj4:PMB2001[A56]1:8; N=362,359,370,228,113
|
99.4 percentage of participants
|
98.9 percentage of participants
|
98.4 percentage of participants
|
76.8 percentage of participants
|
99.1 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
Before Inj1:PMB2948[B24]1:8; N=362,356,369,241,112
|
16.3 percentage of participants
|
13.8 percentage of participants
|
13.0 percentage of participants
|
11.2 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj2:PMB2948[B24]1:8; N=344,345,352,223,110
|
62.2 percentage of participants
|
39.4 percentage of participants
|
43.8 percentage of participants
|
45.3 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj3:PMB2948[B24]1:8; N=328,337,340,237,102
|
50.6 percentage of participants
|
70.3 percentage of participants
|
35.6 percentage of participants
|
73.0 percentage of participants
|
56.9 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj4:PMB2948[B24]1:8; N=354,354,359,228,110
|
89.0 percentage of participants
|
88.4 percentage of participants
|
81.1 percentage of participants
|
35.5 percentage of participants
|
69.1 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
Before Inj1:PMB2707[B44]1:8; N=363,357,370,241,113
|
5.2 percentage of participants
|
6.2 percentage of participants
|
6.2 percentage of participants
|
7.5 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj2:PMB2707[B44]1:8; N=341,345,349,225,111
|
54.0 percentage of participants
|
15.7 percentage of participants
|
17.8 percentage of participants
|
18.2 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants Achieving hSBA Titer >=LLOQ
1M aft Inj4:PMB2707[B44]1:8; N=356,352,356,230,111
|
88.5 percentage of participants
|
86.1 percentage of participants
|
77.5 percentage of participants
|
23.9 percentage of participants
|
73.0 percentage of participants
|
SECONDARY outcome
Timeframe: Before Injection 1, 1 Month after Injection 2, 3, 4Population: The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain.
Outcome measures
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=365 Participants
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=360 Participants
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
n=371 Participants
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
n=241 Participants
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
n=113 Participants
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2948 1:128;N=344,345,352,223,110
|
6.1 percentage of participants
|
3.5 percentage of participants
|
2.6 percentage of participants
|
4.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2707 1:128;N=363,357,370,241,113
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.3 percentage of participants
|
0.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2001[A56] 1:4;N=362,359,370,228,113
|
99.7 percentage of participants
|
99.2 percentage of participants
|
98.9 percentage of participants
|
79.8 percentage of participants
|
99.1 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2001[A56]1:16;N=362,359,370,228,113
|
99.2 percentage of participants
|
98.9 percentage of participants
|
98.4 percentage of participants
|
74.6 percentage of participants
|
99.1 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2001[A56]1:32;N=362,359,370,228,113
|
95.3 percentage of participants
|
96.1 percentage of participants
|
94.6 percentage of participants
|
59.6 percentage of participants
|
92.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2001[A56]1:64;N=362,359,370,228,113
|
87.8 percentage of participants
|
91.1 percentage of participants
|
83.8 percentage of participants
|
34.2 percentage of participants
|
85.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2001 1:128;N=362,359,370,228,113
|
72.4 percentage of participants
|
73.5 percentage of participants
|
65.9 percentage of participants
|
15.8 percentage of participants
|
60.2 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2948[B24]1:4;N=362,356,369,241,112
|
18.5 percentage of participants
|
15.4 percentage of participants
|
14.4 percentage of participants
|
13.3 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2948[B24]1:16;N=362,356,369,241,112
|
12.7 percentage of participants
|
11.5 percentage of participants
|
10.8 percentage of participants
|
8.7 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2948[B24]1:32;N=362,356,369,241,112
|
7.2 percentage of participants
|
6.2 percentage of participants
|
6.0 percentage of participants
|
5.0 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2948[B24]1:64;N=362,356,369,241,112
|
2.8 percentage of participants
|
3.1 percentage of participants
|
2.2 percentage of participants
|
2.1 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2948 1:128;N=362,356,369,241,112
|
1.4 percentage of participants
|
0.8 percentage of participants
|
0.5 percentage of participants
|
0.8 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2948[B24]1:4;N=344,345,352,223,110
|
66.3 percentage of participants
|
42.3 percentage of participants
|
45.7 percentage of participants
|
47.1 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2948[B24]1:16;N=344,345,352,223,110
|
57.6 percentage of participants
|
32.8 percentage of participants
|
39.5 percentage of participants
|
40.4 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2948[B24]1:32;N=344,345,352,223,110
|
34.9 percentage of participants
|
18.6 percentage of participants
|
23.3 percentage of participants
|
24.7 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2948[B24]1:64;N=344,345,352,223,110
|
14.0 percentage of participants
|
9.0 percentage of participants
|
8.8 percentage of participants
|
11.7 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB80[A22] 1:4; N=356,352,364,235,108
|
28.9 percentage of participants
|
23.9 percentage of participants
|
26.4 percentage of participants
|
23.8 percentage of participants
|
25.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2948[B24]1:4;N=328,337,340,237,102
|
52.1 percentage of participants
|
72.1 percentage of participants
|
37.6 percentage of participants
|
75.5 percentage of participants
|
57.8 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB80[A22] 1:16; N=356,352,364,235,108
|
27.2 percentage of participants
|
20.5 percentage of participants
|
22.8 percentage of participants
|
22.1 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB80[A22] 1:32; N=356,352,364,235,108
|
18.3 percentage of participants
|
14.5 percentage of participants
|
13.5 percentage of participants
|
13.2 percentage of participants
|
15.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB80[A22] 1:64; N=356,352,364,235,108
|
7.6 percentage of participants
|
6.5 percentage of participants
|
4.7 percentage of participants
|
6.8 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB80[A22]1:128; N=356,352,364,235,108
|
1.4 percentage of participants
|
2.3 percentage of participants
|
1.6 percentage of participants
|
2.6 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB80[A22] 1:4; N=351,345,351,224,110
|
74.9 percentage of participants
|
47.8 percentage of participants
|
51.3 percentage of participants
|
52.2 percentage of participants
|
29.1 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB80[A22] 1:16; N=351,345,351,224,110
|
73.5 percentage of participants
|
45.8 percentage of participants
|
50.7 percentage of participants
|
51.8 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB80[A22] 1:32; N=351,345,351,224,110
|
58.4 percentage of participants
|
28.7 percentage of participants
|
34.5 percentage of participants
|
37.9 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2948[B24]1:16;N=328,337,340,237,102
|
45.1 percentage of participants
|
63.5 percentage of participants
|
29.7 percentage of participants
|
67.1 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2948[B24]1:32;N=328,337,340,237,102
|
23.8 percentage of participants
|
32.0 percentage of participants
|
15.9 percentage of participants
|
43.5 percentage of participants
|
32.4 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB80[A22] 1:64; N=351,345,351,224,110
|
30.8 percentage of participants
|
14.5 percentage of participants
|
14.5 percentage of participants
|
19.6 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2948[B24]1:64;N=328,337,340,237,102
|
15.5 percentage of participants
|
13.6 percentage of participants
|
5.0 percentage of participants
|
19.4 percentage of participants
|
15.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB80[A22]1:128; N=351,345,351,224,110
|
14.8 percentage of participants
|
5.2 percentage of participants
|
5.7 percentage of participants
|
8.5 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2948 1:128;N=328,337,340,237,102
|
6.7 percentage of participants
|
6.5 percentage of participants
|
2.6 percentage of participants
|
8.4 percentage of participants
|
6.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB80[A22] 1:4; N=332,344,340,238,102
|
63.6 percentage of participants
|
88.7 percentage of participants
|
45.6 percentage of participants
|
90.8 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB80[A22]1:16; N=332,344,340,238,102
|
62.3 percentage of participants
|
88.1 percentage of participants
|
42.4 percentage of participants
|
90.8 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2948[B24]1:4;N=354,354,359,228,110
|
90.1 percentage of participants
|
90.1 percentage of participants
|
83.0 percentage of participants
|
38.2 percentage of participants
|
70.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2948[B24]1:16;N=354,354,359,228,110
|
82.8 percentage of participants
|
83.6 percentage of participants
|
73.8 percentage of participants
|
32.9 percentage of participants
|
64.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2948[B24]1:32;N=354,354,359,228,110
|
60.7 percentage of participants
|
56.2 percentage of participants
|
47.1 percentage of participants
|
18.0 percentage of participants
|
33.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2948[B24]1:64;N=354,354,359,228,110
|
33.3 percentage of participants
|
26.6 percentage of participants
|
22.6 percentage of participants
|
10.5 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2948 1:128;N=354,354,359,228,110
|
13.0 percentage of participants
|
10.5 percentage of participants
|
7.2 percentage of participants
|
3.1 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2707[B44]1:4;N=363,357,370,241,113
|
7.7 percentage of participants
|
7.8 percentage of participants
|
7.8 percentage of participants
|
8.3 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2707[B44]1:16;N=363,357,370,241,113
|
3.6 percentage of participants
|
5.0 percentage of participants
|
4.9 percentage of participants
|
6.6 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2707[B44]1:32;N=363,357,370,241,113
|
3.0 percentage of participants
|
2.5 percentage of participants
|
3.5 percentage of participants
|
2.9 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2707[B44]1:64;N=363,357,370,241,113
|
0.6 percentage of participants
|
1.4 percentage of participants
|
1.4 percentage of participants
|
1.2 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2707[B44]1:4;N=341,345,349,225,111
|
57.5 percentage of participants
|
17.7 percentage of participants
|
20.6 percentage of participants
|
20.4 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB80[A22]1:32; N=332,344,340,238,102
|
47.3 percentage of participants
|
69.5 percentage of participants
|
30.6 percentage of participants
|
70.6 percentage of participants
|
45.1 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2707[B44]1:16;N=341,345,349,225,111
|
47.2 percentage of participants
|
13.6 percentage of participants
|
14.0 percentage of participants
|
14.2 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2707[B44]1:32;N=341,345,349,225,111
|
32.0 percentage of participants
|
9.9 percentage of participants
|
8.3 percentage of participants
|
9.8 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB80[A22]1:64; N=332,344,340,238,102
|
22.3 percentage of participants
|
35.8 percentage of participants
|
12.4 percentage of participants
|
39.1 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2707[B44]1:64;N=341,345,349,225,111
|
18.8 percentage of participants
|
4.1 percentage of participants
|
5.2 percentage of participants
|
6.2 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB80[A22]1:128; N=332,344,340,238,102
|
11.7 percentage of participants
|
14.8 percentage of participants
|
4.4 percentage of participants
|
19.7 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2707 1:128;N=341,345,349,225,111
|
10.0 percentage of participants
|
1.7 percentage of participants
|
3.7 percentage of participants
|
4.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2707[B44]1:4;N=333,331,341,234,105
|
39.0 percentage of participants
|
65.9 percentage of participants
|
15.5 percentage of participants
|
73.5 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2707[B44]1:16;N=333,331,341,234,105
|
30.3 percentage of participants
|
58.6 percentage of participants
|
10.9 percentage of participants
|
64.5 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2707[B44]1:32;N=333,331,341,234,105
|
18.6 percentage of participants
|
39.0 percentage of participants
|
5.9 percentage of participants
|
42.3 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2707[B44]1:64;N=333,331,341,234,105
|
11.4 percentage of participants
|
22.7 percentage of participants
|
3.8 percentage of participants
|
24.4 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB80[A22] 1:4; N=360,357,369,234,111
|
91.9 percentage of participants
|
95.0 percentage of participants
|
94.0 percentage of participants
|
58.1 percentage of participants
|
91.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2707 1:128;N=333,331,341,234,105
|
6.3 percentage of participants
|
7.9 percentage of participants
|
2.6 percentage of participants
|
14.1 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2707[B44]1:4;N=356,352,356,230,111
|
89.3 percentage of participants
|
87.8 percentage of participants
|
78.9 percentage of participants
|
26.1 percentage of participants
|
73.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2707[B44]1:16;N=356,352,356,230,111
|
84.8 percentage of participants
|
83.8 percentage of participants
|
70.8 percentage of participants
|
19.1 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2707[B44]1:32;N=356,352,356,230,111
|
68.5 percentage of participants
|
65.3 percentage of participants
|
49.2 percentage of participants
|
10.0 percentage of participants
|
39.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2707[B44]1:64;N=356,352,356,230,111
|
46.6 percentage of participants
|
42.3 percentage of participants
|
27.8 percentage of participants
|
5.2 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB2707 1:128;N=356,352,356,230,111
|
27.5 percentage of participants
|
22.7 percentage of participants
|
13.8 percentage of participants
|
3.9 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB80[A22] 1:16; N=360,357,369,234,111
|
91.4 percentage of participants
|
95.0 percentage of participants
|
93.2 percentage of participants
|
56.0 percentage of participants
|
91.0 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB80[A22] 1:32; N=360,357,369,234,111
|
84.2 percentage of participants
|
86.6 percentage of participants
|
81.8 percentage of participants
|
38.0 percentage of participants
|
74.8 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB80[A22] 1:64; N=360,357,369,234,111
|
61.9 percentage of participants
|
63.9 percentage of participants
|
53.9 percentage of participants
|
19.2 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj4:PMB80[A22]1:128; N=360,357,369,234,111
|
31.7 percentage of participants
|
32.5 percentage of participants
|
25.7 percentage of participants
|
8.5 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2001[A56] 1:4;N=350,348,355,231,107
|
25.1 percentage of participants
|
22.1 percentage of participants
|
25.1 percentage of participants
|
25.5 percentage of participants
|
25.2 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2001[A56]1:16;N=350,348,355,231,107
|
20.0 percentage of participants
|
18.1 percentage of participants
|
20.3 percentage of participants
|
19.0 percentage of participants
|
16.8 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2001[A56]1:32;N=350,348,355,231,107
|
18.0 percentage of participants
|
14.1 percentage of participants
|
17.2 percentage of participants
|
15.6 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1:PMB2001[A56]1:64;N=350,348,355,231,107
|
11.7 percentage of participants
|
7.5 percentage of participants
|
10.7 percentage of participants
|
8.7 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Inj1: PMB2001 1:128;N=350,348,355,231,107
|
4.3 percentage of participants
|
2.3 percentage of participants
|
3.7 percentage of participants
|
2.6 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2001[A56] 1:4;N=353,329,335,218,102
|
96.6 percentage of participants
|
61.4 percentage of participants
|
63.3 percentage of participants
|
60.1 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2001[A56]1:16;N=353,329,335,218,102
|
96.3 percentage of participants
|
55.0 percentage of participants
|
57.9 percentage of participants
|
55.5 percentage of participants
|
21.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2001[A56]1:32;N=353,329,335,218,102
|
87.8 percentage of participants
|
48.0 percentage of participants
|
50.1 percentage of participants
|
47.2 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2001[A56]1:64;N=353,329,335,218,102
|
72.8 percentage of participants
|
27.4 percentage of participants
|
31.0 percentage of participants
|
29.8 percentage of participants
|
10.8 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj2:PMB2001 1:128;N=353,329,335,218,102
|
41.1 percentage of participants
|
14.3 percentage of participants
|
14.9 percentage of participants
|
15.6 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2001[A56] 1:4;N=329,339,320,240,102
|
91.5 percentage of participants
|
98.5 percentage of participants
|
54.4 percentage of participants
|
100.0 percentage of participants
|
72.5 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2001[A56]1:16;N=329,339,320,240,102
|
87.8 percentage of participants
|
97.9 percentage of participants
|
50.0 percentage of participants
|
99.2 percentage of participants
|
65.7 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2001[A56]1:32;N=329,339,320,240,102
|
79.9 percentage of participants
|
94.1 percentage of participants
|
43.8 percentage of participants
|
95.0 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2001[A56]1:64;N=329,339,320,240,102
|
52.9 percentage of participants
|
79.1 percentage of participants
|
28.4 percentage of participants
|
81.7 percentage of participants
|
39.2 percentage of participants
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1M aft Inj3:PMB2001 1:128;N=329,339,320,240,102
|
26.7 percentage of participants
|
50.4 percentage of participants
|
13.1 percentage of participants
|
57.1 percentage of participants
|
22.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after Injection 2, 3, 4Population: Results were not reported because a decision was made a priori that, although the fold rise outcome measure will still be performed, it will not be performed as a secondary outcome measure. Therefore it was moved from a secondary outcome measure in an earlier protocol version to an exploratory outcome measure in the final protocol.
Outcome measures
Outcome data not reported
Adverse Events
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
Serious events: 12 serious events
Other events: 113 other events
Deaths: 0 deaths
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
Serious events: 14 serious events
Other events: 115 other events
Deaths: 0 deaths
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
Serious events: 7 serious events
Other events: 114 other events
Deaths: 0 deaths
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
Serious events: 7 serious events
Other events: 72 other events
Deaths: 0 deaths
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=426 participants at risk
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=414 participants at risk
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
n=451 participants at risk
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
n=277 participants at risk
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
n=144 participants at risk
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.48%
2/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Gastrointestinal disorders
Constipation
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
General disorders
Chills
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
General disorders
Pyrexia
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.69%
1/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Gastroenteritis
|
0.47%
2/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Localised infection
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Urethritis
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.69%
1/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.69%
1/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Nervous system disorders
Headache
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.48%
2/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Nervous system disorders
Migraine
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
Other adverse events
| Measure |
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)
n=426 participants at risk
Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
|
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)
n=414 participants at risk
Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
|
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)
n=451 participants at risk
Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
|
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)
n=277 participants at risk
Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
|
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)
n=144 participants at risk
Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
|
|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
1.4%
6/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.97%
4/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.67%
3/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.2%
6/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.69%
1/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
General disorders
Pyrexia
|
1.6%
7/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.72%
3/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.89%
4/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.1%
3/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.1%
3/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
General disorders
Fatigue
|
1.2%
5/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.2%
5/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.72%
2/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Nasopharyngitis
|
10.1%
43/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
7.7%
32/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
5.5%
25/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
7.6%
21/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
5.6%
8/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Pharyngitis
|
4.7%
20/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
5.1%
21/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
4.4%
20/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
5.1%
14/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
4.9%
7/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
9/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
3.4%
14/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.7%
12/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.2%
6/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.1%
3/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Gastroenteritis
|
2.3%
10/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.4%
10/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
3.1%
14/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.2%
6/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.1%
3/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Tonsillitis
|
2.3%
10/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.7%
11/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.0%
9/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.9%
8/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Sinusitis
|
1.6%
7/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
6/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.6%
7/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.72%
2/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.1%
3/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Bronchitis
|
0.94%
4/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.2%
5/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.0%
9/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
5/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.97%
4/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.89%
4/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.72%
2/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.69%
1/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Rhinitis
|
0.70%
3/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.97%
4/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.67%
3/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.1%
3/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Otitis media
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.72%
3/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.89%
4/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.97%
4/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.22%
1/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.1%
3/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Tracheitis
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.1%
5/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.47%
2/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.47%
2/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.4%
10/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.67%
3/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.8%
5/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.48%
2/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.89%
4/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.94%
4/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.7%
7/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.44%
2/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.36%
1/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Nervous system disorders
Headache
|
3.1%
13/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.9%
12/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.4%
11/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
2.2%
6/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
4.2%
6/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.23%
1/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.44%
2/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/426 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.24%
1/414 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/451 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
0.00%
0/277 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
1.4%
2/144 • AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)
Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER