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

A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Gardasil (Registered) (Hpv) Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >=11 To <18 Years

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461993

Enrollment

2499

Registered

2011-10-28

Start date

2011-09-28

Completion date

2013-07-06

Last updated

2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccines, Meningococcal Vaccines

Keywords

vaccine, rLP2086, Gardasil, HPV, meningitis B, N. meningitidis serogroup B, adolescents, single-blind, Meningococcal Vaccines

Brief summary

This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.

Interventions

BIOLOGICALrLP2086 and Gardasil

Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.

BIOLOGICALrLP2086

Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.

BIOLOGICALGardasil

Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female subjects from 11 to 17 years old at the time of they start the study. * Subject must be healthy which will be determined by obtaining subject's medical history, receiving a physical examination and by judgment of the investigator.

Exclusion criteria

* Previous vaccination with any meningococcal serogroup B vaccine. * Previous vaccination with any HPV vaccine. * Contraindication to vaccination with Gardasil or any HPV vaccine.

Design outcomes

Primary

Measure	Time frame
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	1 month after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]	1 month after Vaccination 3
Percentage of Participants With at Least One Adverse Event (AE)	Vaccination 1 up to 1 month after Vaccination 3

Secondary

Measure	Time frame
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level	Before Vaccination 1, 1 month after Vaccination 2, 3
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	1 month after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1, 1 month after Vaccination 2, 3
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	Before vaccination 1
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, 1 month after vaccination (Vac) 2, 3

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group 1: rLP2086 + Gardasil Randomized to receive on a 0, 2-, 6- month schedule	999
Group 2: rLP2086 + Saline Randomized to receive on a 0, 2-, 6- month schedule	998
Group 3: Saline + Gardasil Randomized to receive on a 0, 2-, 6- month schedule	502
Total	2,499

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	9	11	3
Overall Study	Did not meet entrance criteria	2	3	0
Overall Study	Lost to Follow-up	44	48	22
Overall Study	No longer met eligibility criteria	13	18	10
Overall Study	Other	13	15	6
Overall Study	Protocol Violation	10	9	7
Overall Study	Withdrawal by Subject	60	53	16

Baseline characteristics

Characteristic	Group 1: rLP2086 + Gardasil	Group 2: rLP2086 + Saline	Group 3: Saline + Gardasil	Total
Age, Customized 11 - less than (<) 15 years	647 participants	660 participants	343 participants	1650 participants
Age, Customized 15 - <18 years	352 participants	338 participants	159 participants	849 participants
Sex: Female, Male Female	341 Participants	332 Participants	170 Participants	843 Participants
Sex: Female, Male Male	658 Participants	666 Participants	332 Participants	1656 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	308 / 992	289 / 990	168 / 501
serious Total, serious adverse events	12 / 992	16 / 990	4 / 501

Outcome results

Primary

Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens

Time frame: 1 month after Vaccination 3

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: rLP2086 + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-6	451.8 titer
Group 1: rLP2086 + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-11	892.9 titer
Group 1: rLP2086 + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-16	3695.4 titer
Group 1: rLP2086 + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-18	744.0 titer
Group 3: Saline + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-18	1047.4 titer
Group 3: Saline + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-6	550.3 titer
Group 3: Saline + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-16	4763.4 titer
Group 3: Saline + Gardasil	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	HPV-11	1084.3 titer

Comparison: HPV-695% CI: [0.72, 0.94]

Comparison: HPV-1195% CI: [0.74, 0.91]

Comparison: HPV-1695% CI: [0.68, 0.88]

Comparison: HPV-1895% CI: [0.62, 0.81]

Primary

Percentage of Participants With at Least One Adverse Event (AE)

Time frame: Vaccination 1 up to 1 month after Vaccination 3

Arm	Measure	Value (NUMBER)
Group 1: rLP2086 + Gardasil	Percentage of Participants With at Least One Adverse Event (AE)	43.9 percentage of participants
Group 3: Saline + Gardasil	Percentage of Participants With at Least One Adverse Event (AE)	41.7 percentage of participants
Group 3: Saline + Gardasil	Percentage of Participants With at Least One Adverse Event (AE)	49.5 percentage of participants

Primary

Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]

Time frame: 1 month after Vaccination 3

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]	PMB80 [A22] (N= 803, 801)	53.3 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]	PMB2948 [B24] (N= 788, 793)	25.8 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]	PMB80 [A22] (N= 803, 801)	57.8 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]	PMB2948 [B24] (N= 788, 793)	28.0 titer

Comparison: PMB80 \[A22\]95% CI: [0.85, 1]

Comparison: PMB2948 \[B24\]95% CI: [0.84, 1.01]

Secondary

Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants

Time frame: Before vaccination 1

Arm	Measure	Group	Value (NUMBER)
Group 1: rLP2086 + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-11	1.5 percentage of participants
Group 1: rLP2086 + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-6	1.4 percentage of participants
Group 1: rLP2086 + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-16	1.6 percentage of participants
Group 1: rLP2086 + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-18	1.0 percentage of participants
Group 3: Saline + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-18	1.2 percentage of participants
Group 3: Saline + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-16	2.4 percentage of participants
Group 3: Saline + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-6	2.1 percentage of participants
Group 3: Saline + Gardasil	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	HPV-11	1.4 percentage of participants

Secondary

Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)

Time frame: 1 month after Vaccination 3

Arm	Measure	Group	Value (NUMBER)
Group 1: rLP2086 + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-6 (N= 802, 414)	99.4 percentage of participants
Group 1: rLP2086 + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-11 (N= 801, 417)	99.6 percentage of participants
Group 1: rLP2086 + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-16 (N= 800, 413)	99.6 percentage of participants
Group 1: rLP2086 + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-18 (N= 805, 418)	99.5 percentage of participants
Group 3: Saline + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-18 (N= 805, 418)	99.0 percentage of participants
Group 3: Saline + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-6 (N= 802, 414)	99.3 percentage of participants
Group 3: Saline + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-16 (N= 800, 413)	99.5 percentage of participants
Group 3: Saline + Gardasil	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	HPV-11 (N= 801, 417)	99.5 percentage of participants

Secondary

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

Time frame: Before vaccination 1, 1 month after vaccination (Vac) 2, 3

Arm	Measure	Group	Value (NUMBER)
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 3: Saline + Gardasil	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)	57.1 percentage of participants
Group 3: Saline + Gardasil	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)	16.4 percentage of participants
Group 3: Saline + Gardasil	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)	6.9 percentage of participants
Group 3: Saline + Gardasil	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)	85.8 percentage of participants
Group 3: Saline + Gardasil	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)	2.5 percentage of participants
Group 3: Saline + Gardasil	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)	96.3 percentage of participants
Group 3: Saline + Gardasil	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)	74.2 percentage of participants
Group 3: Saline + Gardasil	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)	9.3 percentage of participants
Group 3: Saline + Gardasil	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)	85.7 percentage of participants
Group 3: Saline + Gardasil	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)	98.5 percentage of participants
Group 3: Saline + Gardasil	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)	92.6 percentage of participants
Group 3: Saline + Gardasil	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)	99.4 percentage of participants

Secondary

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

Time frame: Before Vaccination 1, 1 month after Vaccination 2, 3

Arm	Measure	Group	Value (NUMBER)
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 1: rLP2086 + Gardasil	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
Group 3: Saline + Gardasil	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)	18.4 percentage of participants
Group 3: Saline + Gardasil	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)	10.6 percentage of participants
Group 3: Saline + Gardasil	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)	18.8 percentage of participants
Group 3: Saline + Gardasil	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)	17.4 percentage of participants
Group 3: Saline + Gardasil	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)	3.6 percentage of participants
Group 3: Saline + Gardasil	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)	0.8 percentage of participants
Group 3: Saline + Gardasil	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)	86.3 percentage of participants
Group 3: Saline + Gardasil	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)	86.1 percentage of participants
Group 3: Saline + Gardasil	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)	69.7 percentage of participants
Group 3: Saline + Gardasil	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)	35.8 percentage of participants
Group 3: Saline + Gardasil	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)	13.0 percentage of participants
Group 3: Saline + Gardasil	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)	96.4 percentage of participants
Group 3: Saline + Gardasil	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)	96.4 percentage of participants
Group 3: Saline + Gardasil	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)	87.0 percentage of participants
Group 3: Saline + Gardasil	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)	61.0 percentage of participants
Group 3: Saline + Gardasil	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)	31.6 percentage of participants
Group 3: Saline + Gardasil	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)	10.5 percentage of participants
Group 3: Saline + Gardasil	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)	9.1 percentage of participants
Group 3: Saline + Gardasil	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)	7.7 percentage of participants
Group 3: Saline + Gardasil	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)	4.6 percentage of participants
Group 3: Saline + Gardasil	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)	1.5 percentage of participants
Group 3: Saline + Gardasil	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)	98.7 percentage of participants
Group 3: Saline + Gardasil	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)	98.4 percentage of participants
Group 3: Saline + Gardasil	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)	93.7 percentage of participants
Group 3: Saline + Gardasil	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)	76.6 percentage of participants
Group 3: Saline + Gardasil	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)	41.5 percentage of participants
Group 3: Saline + Gardasil	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)	99.4 percentage of participants
Group 3: Saline + Gardasil	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)	99.4 percentage of participants
Group 3: Saline + Gardasil	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)	97.3 percentage of participants
Group 3: Saline + Gardasil	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)	89.2 percentage of participants
Group 3: Saline + Gardasil	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)	67.2 percentage of participants
Group 3: Saline + Gardasil	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)	8.4 percentage of participants
Group 3: Saline + Gardasil	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)	5.4 percentage of participants
Group 3: Saline + Gardasil	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)	3.0 percentage of participants
Group 3: Saline + Gardasil	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)	1.0 percentage of participants
Group 3: Saline + Gardasil	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)	0.5 percentage of participants
Group 3: Saline + Gardasil	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)	77.1 percentage of participants
Group 3: Saline + Gardasil	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)	68.8 percentage of participants
Group 3: Saline + Gardasil	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)	38.7 percentage of participants
Group 3: Saline + Gardasil	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)	12.5 percentage of participants
Group 3: Saline + Gardasil	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)	5.6 percentage of participants
Group 3: Saline + Gardasil	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)	92.8 percentage of participants
Group 3: Saline + Gardasil	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)	89.2 percentage of participants
Group 3: Saline + Gardasil	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)	60.9 percentage of participants
Group 3: Saline + Gardasil	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)	25.2 percentage of participants
Group 3: Saline + Gardasil	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)	8.4 percentage of participants
Group 3: Saline + Gardasil	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)	3.2 percentage of participants
Group 3: Saline + Gardasil	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)	2.1 percentage of participants
Group 3: Saline + Gardasil	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)	1.4 percentage of participants
Group 3: Saline + Gardasil	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)	0.7 percentage of participants
Group 3: Saline + Gardasil	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)	0.2 percentage of participants
Group 3: Saline + Gardasil	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)	60.1 percentage of participants
Group 3: Saline + Gardasil	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)	49.9 percentage of participants
Group 3: Saline + Gardasil	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)	26.9 percentage of participants
Group 3: Saline + Gardasil	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)	11.9 percentage of participants
Group 3: Saline + Gardasil	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)	5.7 percentage of participants
Group 3: Saline + Gardasil	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)	86.5 percentage of participants
Group 3: Saline + Gardasil	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)	82.4 percentage of participants
Group 3: Saline + Gardasil	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)	62.3 percentage of participants
Group 3: Saline + Gardasil	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)	39.4 percentage of participants

Secondary

Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)

Time frame: Before Vaccination 1, 1 month after Vaccination 2, 3

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB80 [A22] (N=794,799)	9.6 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB80 [A22] (N=794,801)	31.9 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB2001 [A56] (N=757,740)	5.0 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB2001 [A56] (N=790,795)	70.6 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 3: PMB2001 [A56] (N=796,802)	117.2 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB2948 [B24] (N=801,793)	4.3 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB2948 [B24] (N=770,770)	15.0 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB2707 [B44] (N=806,805)	4.1 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB2707 [B44] (N=783,776)	11.1 titer
Group 1: rLP2086 + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 3: PMB2707 [B44] (N=799,795)	27.2 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB2707 [B44] (N=806,805)	4.2 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB80 [A22] (N=794,799)	9.9 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB2948 [B24] (N=801,793)	4.5 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB80 [A22] (N=794,801)	33.7 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 3: PMB2707 [B44] (N=799,795)	31.9 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1: PMB2001 [A56] (N=757,740)	5.0 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB2948 [B24] (N=770,770)	16.3 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB2001 [A56] (N=790,795)	76.3 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 2: PMB2707 [B44] (N=783,776)	11.9 titer
Group 3: Saline + Gardasil	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	1 month after Vac 3: PMB2001 [A56] (N=796,802)	128.2 titer

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens

Percentage of Participants With at Least One Adverse Event (AE)

Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]

Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants

Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)