Trial Outcomes & Findings for A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17 (NCT NCT01461993)
NCT ID: NCT01461993
Last Updated: 2018-12-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2499 participants
Primary outcome timeframe
1 month after Vaccination 3
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
Group 1: rLP2086 + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 2: rLP2086 + Saline
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Overall Study
STARTED
|
999
|
998
|
502
|
|
Overall Study
COMPLETED
|
848
|
841
|
438
|
|
Overall Study
NOT COMPLETED
|
151
|
157
|
64
|
Reasons for withdrawal
| Measure |
Group 1: rLP2086 + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 2: rLP2086 + Saline
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
60
|
53
|
16
|
|
Overall Study
Lost to Follow-up
|
44
|
48
|
22
|
|
Overall Study
Protocol Violation
|
10
|
9
|
7
|
|
Overall Study
Adverse Event
|
9
|
11
|
3
|
|
Overall Study
No longer met eligibility criteria
|
13
|
18
|
10
|
|
Overall Study
Did not meet entrance criteria
|
2
|
3
|
0
|
|
Overall Study
Other
|
13
|
15
|
6
|
Baseline Characteristics
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
Baseline characteristics by cohort
| Measure |
Group 1: rLP2086 + Gardasil
n=999 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 2: rLP2086 + Saline
n=998 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=502 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Total
n=2499 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
11 - less than (<) 15 years
|
647 participants
n=5 Participants
|
660 participants
n=7 Participants
|
343 participants
n=5 Participants
|
1650 participants
n=4 Participants
|
|
Age, Customized
15 - <18 years
|
352 participants
n=5 Participants
|
338 participants
n=7 Participants
|
159 participants
n=5 Participants
|
849 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
341 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
843 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
658 Participants
n=5 Participants
|
666 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
1656 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 3Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=813 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=423 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
HPV-6
|
451.8 titer
Interval 417.5 to 489.01
|
550.3 titer
Interval 490.44 to 617.58
|
—
|
|
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
HPV-11
|
892.9 titer
Interval 839.52 to 949.57
|
1084.3 titer
Interval 997.28 to 1178.96
|
—
|
|
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
HPV-16
|
3695.4 titer
Interval 3426.32 to 3985.67
|
4763.4 titer
Interval 4285.85 to 5294.21
|
—
|
|
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
HPV-18
|
744.0 titer
Interval 687.67 to 804.96
|
1047.4 titer
Interval 939.0 to 1168.25
|
—
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 3Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=814 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=812 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]
PMB80 [A22] (N= 803, 801)
|
53.3 titer
Interval 50.22 to 56.66
|
57.8 titer
Interval 54.44 to 61.44
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]
PMB2948 [B24] (N= 788, 793)
|
25.8 titer
Interval 24.14 to 27.56
|
28.0 titer
Interval 26.24 to 29.87
|
—
|
PRIMARY outcome
Timeframe: Vaccination 1 up to 1 month after Vaccination 3Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=992 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=990 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=501 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE)
|
43.9 percentage of participants
Interval 40.7 to 47.0
|
41.7 percentage of participants
Interval 38.6 to 44.9
|
49.5 percentage of participants
Interval 45.0 to 54.0
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 3Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=809 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=419 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
HPV-6 (N= 802, 414)
|
99.4 percentage of participants
|
99.3 percentage of participants
|
—
|
|
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
HPV-11 (N= 801, 417)
|
99.6 percentage of participants
|
99.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
HPV-16 (N= 800, 413)
|
99.6 percentage of participants
|
99.5 percentage of participants
|
—
|
|
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
HPV-18 (N= 805, 418)
|
99.5 percentage of participants
|
99.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Before vaccination 1Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=814 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=423 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
HPV-16
|
1.6 percentage of participants
|
2.4 percentage of participants
|
—
|
|
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
HPV-6
|
1.4 percentage of participants
|
2.1 percentage of participants
|
—
|
|
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
HPV-11
|
1.5 percentage of participants
|
1.4 percentage of participants
|
—
|
|
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
HPV-18
|
1.0 percentage of participants
|
1.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Before vaccination 1, 1 month after vaccination (Vac) 2, 3Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=814 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=812 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Before Vaccination 1:PMB80[A22] 1:16 (N= 794, 799)
|
13.7 percentage of participants
|
16.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 2: PMB80[A22] 1:16 (N= 794, 801)
|
83.0 percentage of participants
|
85.8 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 3: PMB80[A22] 1:16 (N= 803, 801)
|
94.0 percentage of participants
|
96.3 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Before Vaccination 1:PMB2001[A56] 1:8(N= 757, 740)
|
9.2 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 2: PMB2001[A56] 1:8 (N= 790,795)
|
97.5 percentage of participants
|
98.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 3: PMB2001[A56] 1:8 (N= 796,802)
|
98.9 percentage of participants
|
99.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Before Vaccination 1:PMB2948[B24] 1:8(N= 801, 793)
|
5.1 percentage of participants
|
6.9 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 2: PMB2948[B24] 1:8 (N= 770,770)
|
70.6 percentage of participants
|
74.2 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 3: PMB2948[B24] 1:8 (N= 788,793)
|
90.5 percentage of participants
|
92.6 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Before Vaccination 1:PMB2707[B44] 1:8(N= 806, 805)
|
1.4 percentage of participants
|
2.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 2: PMB2707[B44] 1:8 (N= 783,776)
|
54.5 percentage of participants
|
57.1 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
1 month after Vac 3: PMB2707[B44] 1:8 (N= 799,795)
|
82.7 percentage of participants
|
85.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Before Vaccination 1, 1 month after Vaccination 2, 3Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=814 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=812 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2707[B44] 1:128(N=783,776)
|
5.0 percentage of participants
|
5.7 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2707 [B44] 1:4 (N=799,795)
|
84.4 percentage of participants
|
86.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2707[B44] 1:16 (N=799,795)
|
78.0 percentage of participants
|
82.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2707[B44] 1:32 (N=799,795)
|
57.7 percentage of participants
|
62.3 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2707[B44] 1:64 (N=799,795)
|
34.7 percentage of participants
|
39.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2707[B44] 1:128(N=799,795)
|
15.1 percentage of participants
|
18.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB80 [A22] 1:4 (N=794,799)
|
15.2 percentage of participants
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB80 [A22] 1:8 (N=794,799)
|
14.2 percentage of participants
|
17.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB80 [A22] 1:32 (N=794,799)
|
9.4 percentage of participants
|
10.6 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB80 [A22] 1:64 (N=794,799)
|
2.8 percentage of participants
|
3.6 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB80[A22] 1:128 (N=794,799)
|
0.5 percentage of participants
|
0.8 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB80 [A22] 1:4 (N=794,801)
|
83.8 percentage of participants
|
86.3 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB80 [A22] 1:8 (N=794,801)
|
83.2 percentage of participants
|
86.1 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB80 [A22] 1:32 (N=794,801)
|
66.9 percentage of participants
|
69.7 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB80 [A22] 1:64 (N=794,801)
|
35.9 percentage of participants
|
35.8 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB80 [A22] 1:128 (N=794,801)
|
11.0 percentage of participants
|
13.0 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB80 [A22] 1:4 (N=803,801)
|
94.3 percentage of participants
|
96.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB80 [A22] 1:8 (N=803,801)
|
94.3 percentage of participants
|
96.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB80 [A22] 1:32 (N=803,801)
|
86.3 percentage of participants
|
87.0 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB80 [A22] 1:64 (N=803,801)
|
58.0 percentage of participants
|
61.0 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB80 [A22] 1:128 (N=803,801)
|
28.1 percentage of participants
|
31.6 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2001[A56] 1:4 (N=757,740)
|
10.4 percentage of participants
|
10.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2001[A56] 1:16(N=757,740)
|
9.0 percentage of participants
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2001[A56] 1:32(N=757,740)
|
8.1 percentage of participants
|
7.7 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2001[A56] 1:64(N=757,740)
|
4.9 percentage of participants
|
4.6 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1:PMB2001[A56] 1:128(N=757,740)
|
1.7 percentage of participants
|
1.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2001 [A56] 1:4 (N=790,795)
|
97.8 percentage of participants
|
98.7 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2001[A56] 1:16 (N=790,795)
|
97.2 percentage of participants
|
98.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2001[A56] 1:32 (N=790,795)
|
91.3 percentage of participants
|
93.7 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2001[A56] 1:64 (N=790,795)
|
71.6 percentage of participants
|
76.6 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2001[A56] 1:128(N=790,795)
|
40.4 percentage of participants
|
41.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2001 [A56] 1:4 (n=796,802)
|
99.1 percentage of participants
|
99.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2001[A56] 1:16 (N=796,802)
|
98.9 percentage of participants
|
99.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2001[A56] 1:32 (N=796,802)
|
96.7 percentage of participants
|
97.3 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2001[A56] 1:64 (N=796,802)
|
88.1 percentage of participants
|
89.2 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2001[A56] 1:128(N=796,802)
|
63.6 percentage of participants
|
67.2 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2948[B24] 1:4 (N=801,793)
|
6.1 percentage of participants
|
8.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2948[B24] 1:16(N=801,793)
|
4.1 percentage of participants
|
5.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2948[B24] 1:32(N=801,793)
|
1.7 percentage of participants
|
3.0 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2948[B24] 1:64(N=801,793)
|
0.6 percentage of participants
|
1.0 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1:PMB2948[B24] 1:128(N=801,793)
|
0.1 percentage of participants
|
0.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2948 [B24] 1:4 (N=770,770)
|
71.9 percentage of participants
|
77.1 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2948[B24] 1:16 (N=770,770)
|
65.2 percentage of participants
|
68.8 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2948[B24] 1:32 (N=770,770)
|
33.9 percentage of participants
|
38.7 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2948[B24] 1:64 (N=770,770)
|
13.1 percentage of participants
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2948[B24] 1:128(N=770,770)
|
5.3 percentage of participants
|
5.6 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2948 [B24] 1:4 (N=788,793)
|
91.1 percentage of participants
|
92.8 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2948[B24] 1:16 (N=788,793)
|
86.3 percentage of participants
|
89.2 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2948[B24] 1:32 (N=788,793)
|
57.2 percentage of participants
|
60.9 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2948[B24] 1:64 (N=788,793)
|
23.9 percentage of participants
|
25.2 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 3: PMB2948[B24] 1:128(N=788,793)
|
7.6 percentage of participants
|
8.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2707[B44] 1:4 (N=806,805)
|
1.7 percentage of participants
|
3.2 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2707[B44] 1:16(N=806,805)
|
1.2 percentage of participants
|
2.1 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2707[B44] 1:32(N=806,805)
|
0.6 percentage of participants
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1: PMB2707[B44] 1:64(N=806,805)
|
0.1 percentage of participants
|
0.7 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1:PMB2707[B44] 1:128(N=806,805)
|
0.0 percentage of participants
|
0.2 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2707 [B44] 1:4 (N=783,776)
|
57.7 percentage of participants
|
60.1 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2707[B44] 1:16 (N=783,776)
|
46.4 percentage of participants
|
49.9 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2707[B44] 1:32 (N=783,776)
|
25.7 percentage of participants
|
26.9 percentage of participants
|
—
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
1 month after Vac 2: PMB2707[B44] 1:64 (N=783,776)
|
11.2 percentage of participants
|
11.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Before Vaccination 1, 1 month after Vaccination 2, 3Outcome measures
| Measure |
Group 1: rLP2086 + Gardasil
n=814 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=812 Participants
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
1 month after Vac 3: PMB2001 [A56] (N=796,802)
|
117.2 titer
Interval 110.14 to 124.76
|
128.2 titer
Interval 120.65 to 136.27
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
Before Vaccination 1: PMB80 [A22] (N=794,799)
|
9.6 titer
Interval 9.28 to 9.96
|
9.9 titer
Interval 9.58 to 10.33
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
1 month after Vac 2: PMB80 [A22] (N=794,801)
|
31.9 titer
Interval 29.96 to 33.94
|
33.7 titer
Interval 31.69 to 35.85
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
Before Vaccination 1: PMB2001 [A56] (N=757,740)
|
5.0 titer
Interval 4.78 to 5.32
|
5.0 titer
Interval 4.75 to 5.28
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
1 month after Vac 2: PMB2001 [A56] (N=790,795)
|
70.6 titer
Interval 66.17 to 75.34
|
76.3 titer
Interval 71.93 to 80.99
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
Before Vaccination 1: PMB2948 [B24] (N=801,793)
|
4.3 titer
Interval 4.23 to 4.46
|
4.5 titer
Interval 4.35 to 4.65
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
1 month after Vac 2: PMB2948 [B24] (N=770,770)
|
15.0 titer
Interval 13.88 to 16.15
|
16.3 titer
Interval 15.15 to 17.62
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
Before Vaccination 1: PMB2707 [B44] (N=806,805)
|
4.1 titer
Interval 4.04 to 4.15
|
4.2 titer
Interval 4.1 to 4.31
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
1 month after Vac 2: PMB2707 [B44] (N=783,776)
|
11.1 titer
Interval 10.21 to 12.01
|
11.9 titer
Interval 10.94 to 12.96
|
—
|
|
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
1 month after Vac 3: PMB2707 [B44] (N=799,795)
|
27.2 titer
Interval 24.99 to 29.68
|
31.9 titer
Interval 29.25 to 34.82
|
—
|
Adverse Events
Group 1: rLP2086 + Gardasil
Serious events: 12 serious events
Other events: 308 other events
Deaths: 0 deaths
Group 2: rLP2086 + Saline
Serious events: 16 serious events
Other events: 289 other events
Deaths: 0 deaths
Group 3: Saline + Gardasil
Serious events: 4 serious events
Other events: 168 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: rLP2086 + Gardasil
n=992 participants at risk
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 2: rLP2086 + Saline
n=990 participants at risk
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=501 participants at risk
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.20%
1/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.20%
1/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Appendicitis
|
0.20%
2/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Musculoskeletal and connective tissue disorders
Epiphysiolysis
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular fasciitis
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Nervous system disorders
Migraine
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.20%
1/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Depression suicidal
|
0.20%
2/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Suicide attempt
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Anxiety
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Cyclothymic disorder
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.20%
1/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
0.10%
1/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.10%
1/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.00%
0/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
Other adverse events
| Measure |
Group 1: rLP2086 + Gardasil
n=992 participants at risk
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 2: rLP2086 + Saline
n=990 participants at risk
Randomized to receive on a 0, 2-, 6- month schedule
|
Group 3: Saline + Gardasil
n=501 participants at risk
Randomized to receive on a 0, 2-, 6- month schedule
|
|---|---|---|---|
|
General disorders
Injection site swelling
|
1.1%
11/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.81%
8/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.40%
2/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
12/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.0%
10/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.2%
6/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
15/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.61%
6/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.40%
2/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
General disorders
Injection site pain
|
5.0%
50/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
4.3%
43/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
4.2%
21/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
General disorders
Pyrexia
|
1.5%
15/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.1%
11/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.00%
5/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
General disorders
Fatigue
|
1.0%
10/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.81%
8/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.60%
3/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
49/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
5.4%
53/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
5.8%
29/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Pharyngitis
|
2.0%
20/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
3.6%
36/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.8%
9/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
23/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.3%
23/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.8%
14/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.8%
18/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.4%
14/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
3.0%
15/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Gastroenteritis
|
2.3%
23/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.1%
11/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.6%
8/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Viral infection
|
1.4%
14/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.0%
10/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.2%
11/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Sinusitis
|
1.8%
18/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.1%
11/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.00%
5/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Gastroenteritis viral
|
0.91%
9/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.81%
8/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.6%
8/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Acute sinusitis
|
0.50%
5/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.3%
13/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.2%
6/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.91%
9/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.1%
11/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.0%
10/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Otitis media
|
1.1%
11/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.91%
9/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.40%
2/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Pneumonia
|
0.71%
7/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.71%
7/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.2%
6/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Infections and infestations
Viral pharyngitis
|
0.20%
2/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.61%
6/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.6%
8/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.6%
16/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.0%
20/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.0%
10/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.2%
12/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.51%
5/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.40%
2/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
11/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.81%
8/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.80%
4/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Nervous system disorders
Headache
|
5.0%
50/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
3.8%
38/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
4.2%
21/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
19/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.6%
16/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.8%
14/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
12/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.3%
23/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.2%
6/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
10/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.2%
12/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.4%
7/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
11/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.40%
4/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
0.80%
4/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.3%
13/992 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
1.0%
10/990 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
2.0%
10/501 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Gardasil). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Gardasil)
Events collected on case report form were reported.
|
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