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
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01461993
Collaborator
(none)
2,499
87
3
21.3
28.7
1.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2499 participants
Allocation:
Randomized
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date
:
Sep 28, 2011
Actual Primary Completion Date
:
Jul 6, 2013
Actual Study Completion Date
:
Jul 6, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 rLP2086 + Gardasil |
Biological: rLP2086 and Gardasil
Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.
|
| Placebo Comparator: Group 2 rLP2086 and saline |
Biological: rLP2086
Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
|
| Active Comparator: Group 3 Saline + Gardasil |
Biological: Gardasil
Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV) [1 month after Vaccination 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]
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level [Before Vaccination 1, 1 month after Vaccination 2, 3]
- Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT) [Before Vaccination 1, 1 month after Vaccination 2, 3]
Eligibility Criteria
Criteria
Ages Eligible for Study:
11 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Coastal Clinical Research Inc. | Daphne | Alabama | United States | 36526 |
| 2 | Radiant Research, Inc. | Chandler | Arizona | United States | 85224 |
| 3 | The Children's Clinic of Jonesboro, PA | Jonesboro | Arkansas | United States | 72401 |
| 4 | Arkansas Pediatric Clinic | Little Rock | Arkansas | United States | 72205 |
| 5 | West Coast Clinical Trials, LLC | Cypress | California | United States | 90630 |
| 6 | Pediatric Care Medical Group | Huntington Beach | California | United States | 92647 |
| 7 | Loma Linda University Health Care - Moreno Valley Pediatrics | Moreno Valley | California | United States | 92557 |
| 8 | Bayview Research Group, LLC | Paramount | California | United States | 90723 |
| 9 | Center for Clinical Trials, LLC | Paramount | California | United States | 90723 |
| 10 | California Research Foundation | San Diego | California | United States | 92103 |
| 11 | Bayview Research Group, LLC | Valley Village | California | United States | 91607 |
| 12 | Lynn Institute of the Rockies | Colorado Springs | Colorado | United States | 80907 |
| 13 | Colorado Springs Family Practice | Colorado Springs | Colorado | United States | 80909 |
| 14 | Miami Research Associates | Miami | Florida | United States | 33143 |
| 15 | Pediatrics and Adolescent Medicine, PA | Marietta | Georgia | United States | 30062 |
| 16 | Clinical Research Atlanta | Stockbridge | Georgia | United States | 30281 |
| 17 | Pediatrics and Adolescent Medicine | Woodstock | Georgia | United States | 30189 |
| 18 | Advanced Clinical Research | Meridian | Idaho | United States | 83642 |
| 19 | Northpoint Pediatrics, LLC | Indianapolis | Indiana | United States | 46256 |
| 20 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67207 |
| 21 | Kentucky Pediatric/Adult Research | Bardstown | Kentucky | United States | 40004 |
| 22 | Central Kentucky Research Associates, Inc. | Lexington | Kentucky | United States | 40509 |
| 23 | Brownsboro Park Pediatrics | Louisville | Kentucky | United States | 40207 |
| 24 | Bluegrass Clinical Research, Inc. | Louisville | Kentucky | United States | 40291 |
| 25 | Allina Health Bandana Square Clinic | Saint Paul | Minnesota | United States | 55108 |
| 26 | Aspen Medical Group / Odyssey Research | Saint Paul | Minnesota | United States | 55108 |
| 27 | The Center for Pharmaceutical Research, PC | Kansas City | Missouri | United States | 64114 |
| 28 | Mercy Health Research | Saint Louis | Missouri | United States | 63141 |
| 29 | Sundance Clinical Research, LLC | Saint Louis | Missouri | United States | 63141 |
| 30 | Sundance Clinical Research | Saint Louis | Missouri | United States | 63141 |
| 31 | Midwest Children's Health Research Institute | Lincoln | Nebraska | United States | 68504 |
| 32 | Quality Clinical Research, Inc. | Omaha | Nebraska | United States | 68114 |
| 33 | Clinical Research Center of Nevada | Henderson | Nevada | United States | 89014 |
| 34 | Clinical Research Center of Nevada | Henderson | Nevada | United States | 89105 |
| 35 | Clinical Research Center of Nevada | Las Vegas | Nevada | United States | 89105 |
| 36 | Rochester Clinical Research, Inc. | Rochester | New York | United States | 14609 |
| 37 | Rochester Clinical Research | Rochester | New York | United States | 14609 |
| 38 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 39 | Cary Pediatric Center | Cary | North Carolina | United States | 27518 |
| 40 | Duke University Medical Center - Duke Health Center | Durham | North Carolina | United States | 27704 |
| 41 | Durham Pediatrics | Durham | North Carolina | United States | 27704 |
| 42 | Duke Health Center | Durham | North Carolina | United States | 27705 |
| 43 | PMG Research of Raleigh, LLC | Raleigh | North Carolina | United States | 27609 |
| 44 | PMG Research of Raleigh, LLC | Raleigh | North Carolina | United States | 27612 |
| 45 | Wake Internal Medicine Consultants, Inc | Raleigh | North Carolina | United States | 27612 |
| 46 | Wake Research Associates | Raleigh | North Carolina | United States | 27612 |
| 47 | Innovis Health, LLC dba Essentia Health South University Clinic | Fargo | North Dakota | United States | 58103 |
| 48 | Cincinnati Children's Hospital Medical Center (CCHMC) | Cincinnati | Ohio | United States | 45206 |
| 49 | Cincinnati Children's Hospital Medical Center (CCHMC) | Cincinnati | Ohio | United States | 45229-3039 |
| 50 | Senders Pediatrics | Cleveland | Ohio | United States | 44121 |
| 51 | Rapid Medical Research, Inc. | Cleveland | Ohio | United States | 44122 |
| 52 | Lynn Institute of Norman (LION) | Norman | Oklahoma | United States | 73069 |
| 53 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 54 | Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center | Tulsa | Oklahoma | United States | 74127 |
| 55 | Oklahoma State University - Center for Health Sciences Houston Parke Physicians | Tulsa | Oklahoma | United States | 74127 |
| 56 | Preferred Primary Care Physicians, Inc. | Carnegie | Pennsylvania | United States | 15106 |
| 57 | Liberty Family Practice | Erie | Pennsylvania | United States | 16508 |
| 58 | Pennridge Pediatric Associates | Sellersville | Pennsylvania | United States | 18960 |
| 59 | Richard K. Ohnmacht, MD | Cranston | Rhode Island | United States | 02920 |
| 60 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
| 61 | Charleston Pediatrics | Charleston | South Carolina | United States | 29401 |
| 62 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
| 63 | PMG Research of Charleston | Mount Pleasant | South Carolina | United States | 29464 |
| 64 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
| 65 | Benchmark Research | Austin | Texas | United States | 78705 |
| 66 | The Office of Dr. Roberta Braun, MD | Austin | Texas | United States | 78705 |
| 67 | Advances In Health, Inc. | Houston | Texas | United States | 77030 |
| 68 | Pediatric Healthcare of Northwest Houston | Houston | Texas | United States | 77070 |
| 69 | Texas Center for Drug Development, Inc. | Houston | Texas | United States | 77081 |
| 70 | University of Texas Medical Branch Pediatric Specialty Center | League City | Texas | United States | 77573 |
| 71 | Benchmark Research | San Angelo | Texas | United States | 76904 |
| 72 | Clinical Trials Of Texas, Inc | San Antonio | Texas | United States | 78229 |
| 73 | Clinical Trials of Texas | San Antonio | Texas | United States | 78229 |
| 74 | First Steps Pediatrics | San Antonio | Texas | United States | 78229 |
| 75 | Radiant Research, Inc. | San Antonio | Texas | United States | 78229 |
| 76 | Pediatric Healthcare of Northwest Houston, PA | Tomball | Texas | United States | 77375 |
| 77 | Pediatric Healthcare of Northwest Houston | Tomball | Texas | United States | 77375 |
| 78 | Murray Pediatrics | Murray | Utah | United States | 84107 |
| 79 | Jean Brown Research | Salt Lake City | Utah | United States | 84124 |
| 80 | Pediatric Associates of Charlottesville | Charlottesville | Virginia | United States | 22902 |
| 81 | West Office - Pediatric Associates of Charlottesville | Charlottesville | Virginia | United States | 22903 |
| 82 | North Office - Pediatric Associates of Charlottesville | Charlottesville | Virginia | United States | 22911 |
| 83 | Clinical Research Associates of Tidewater | Norfolk | Virginia | United States | 23507 |
| 84 | Advanced Pediatrics | Vienna | Virginia | United States | 22180 |
| 85 | The Vancouver Clinic | Vancouver | Washington | United States | 98664 |
| 86 | The Vancouver Clinic | Vancouver | Washington | United States | 98686 |
| 87 | Monroe Clinic | Monroe | Wisconsin | United States | 53566 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01461993
Other Study ID Numbers:
- B1971011
- 6108A1-2007
First Posted:
Oct 28, 2011
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018
Keywords provided by Pfizer
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline | Group 3: Saline + Gardasil |
|---|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Period Title: Overall Study | |||
| STARTED | 999 | 998 | 502 |
| COMPLETED | 848 | 841 | 438 |
| NOT COMPLETED | 151 | 157 | 64 |
Baseline Characteristics
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline | Group 3: Saline + Gardasil | Total |
|---|---|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule | Total of all reporting groups |
| Overall Participants | 999 | 998 | 502 | 2499 |
| Age, Customized (participants) [Number] | ||||
| 11 - less than (<) 15 years |
647
64.8%
|
660
66.1%
|
343
68.3%
|
1650
66%
|
| 15 - <18 years |
352
35.2%
|
338
33.9%
|
159
31.7%
|
849
34%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
341
34.1%
|
332
33.3%
|
170
33.9%
|
843
33.7%
|
| Male |
658
65.9%
|
666
66.7%
|
332
66.1%
|
1656
66.3%
|
Outcome Measures
| Title | Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens |
|---|---|
| Description | |
| Time Frame | 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 3: Saline + Gardasil |
|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 813 | 423 |
| HPV-6 |
451.8
|
550.3
|
| HPV-11 |
892.9
|
1084.3
|
| HPV-16 |
3695.4
|
4763.4
|
| HPV-18 |
744.0
|
1047.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Gardasil, Group 3: Saline + Gardasil |
|---|---|---|
| Comments | HPV-6 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.82 | |
| Confidence Interval |
() 95% 0.72 to 0.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Gardasil, Group 3: Saline + Gardasil |
|---|---|---|
| Comments | HPV-11 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 0.91 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Gardasil, Group 3: Saline + Gardasil |
|---|---|---|
| Comments | HPV-16 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.68 to 0.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Gardasil, Group 3: Saline + Gardasil |
|---|---|---|
| Comments | HPV-18 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 0.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] |
|---|---|
| Description | |
| Time Frame | 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 814 | 812 |
| PMB80 [A22] (N= 803, 801) |
53.3
|
57.8
|
| PMB2948 [B24] (N= 788, 793) |
25.8
|
28.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Gardasil, Group 3: Saline + Gardasil |
|---|---|---|
| Comments | PMB80 [A22] | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: rLP2086 + Gardasil, Group 3: Saline + Gardasil |
|---|---|---|
| Comments | PMB2948 [B24] | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The non-inferiority criteria margin was 1.5-fold. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT Ratio |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.84 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV) |
|---|---|
| Description | |
| Time Frame | 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 3: Saline + Gardasil |
|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 809 | 419 |
| HPV-6 (N= 802, 414) |
99.4
9.9%
|
99.3
9.9%
|
| HPV-11 (N= 801, 417) |
99.6
10%
|
99.5
10%
|
| HPV-16 (N= 800, 413) |
99.6
10%
|
99.5
10%
|
| HPV-18 (N= 805, 418) |
99.5
10%
|
99.0
9.9%
|
| Title | Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants |
|---|---|
| Description | |
| Time Frame | Before vaccination 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 3: Saline + Gardasil |
|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 814 | 423 |
| HPV-6 |
1.4
0.1%
|
2.1
0.2%
|
| HPV-11 |
1.5
0.2%
|
1.4
0.1%
|
| HPV-16 |
1.6
0.2%
|
2.4
0.2%
|
| HPV-18 |
1.0
0.1%
|
1.2
0.1%
|
| Title | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) |
|---|---|
| Description | |
| Time Frame | Before vaccination 1, 1 month after vaccination (Vac) 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 814 | 812 |
| Before Vaccination 1:PMB80[A22] 1:16 (N= 794, 799) |
13.7
1.4%
|
16.4
1.6%
|
| 1 month after Vac 2: PMB80[A22] 1:16 (N= 794, 801) |
83.0
8.3%
|
85.8
8.6%
|
| 1 month after Vac 3: PMB80[A22] 1:16 (N= 803, 801) |
94.0
9.4%
|
96.3
9.6%
|
| Before Vaccination 1:PMB2001[A56] 1:8(N= 757, 740) |
9.2
0.9%
|
9.3
0.9%
|
| 1 month after Vac 2: PMB2001[A56] 1:8 (N= 790,795) |
97.5
9.8%
|
98.5
9.9%
|
| 1 month after Vac 3: PMB2001[A56] 1:8 (N= 796,802) |
98.9
9.9%
|
99.4
10%
|
| Before Vaccination 1:PMB2948[B24] 1:8(N= 801, 793) |
5.1
0.5%
|
6.9
0.7%
|
| 1 month after Vac 2: PMB2948[B24] 1:8 (N= 770,770) |
70.6
7.1%
|
74.2
7.4%
|
| 1 month after Vac 3: PMB2948[B24] 1:8 (N= 788,793) |
90.5
9.1%
|
92.6
9.3%
|
| Before Vaccination 1:PMB2707[B44] 1:8(N= 806, 805) |
1.4
0.1%
|
2.5
0.3%
|
| 1 month after Vac 2: PMB2707[B44] 1:8 (N= 783,776) |
54.5
5.5%
|
57.1
5.7%
|
| 1 month after Vac 3: PMB2707[B44] 1:8 (N= 799,795) |
82.7
8.3%
|
85.7
8.6%
|
| Title | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level |
|---|---|
| Description | |
| Time Frame | Before Vaccination 1, 1 month after Vaccination 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 814 | 812 |
| Before Vaccination 1: PMB80 [A22] 1:4 (N=794,799) |
15.2
1.5%
|
18.8
1.9%
|
| Before Vaccination 1: PMB80 [A22] 1:8 (N=794,799) |
14.2
1.4%
|
17.4
1.7%
|
| Before Vaccination 1: PMB80 [A22] 1:32 (N=794,799) |
9.4
0.9%
|
10.6
1.1%
|
| Before Vaccination 1: PMB80 [A22] 1:64 (N=794,799) |
2.8
0.3%
|
3.6
0.4%
|
| Before Vaccination 1: PMB80[A22] 1:128 (N=794,799) |
0.5
0.1%
|
0.8
0.1%
|
| 1 month after Vac 2: PMB80 [A22] 1:4 (N=794,801) |
83.8
8.4%
|
86.3
8.6%
|
| 1 month after Vac 2: PMB80 [A22] 1:8 (N=794,801) |
83.2
8.3%
|
86.1
8.6%
|
| 1 month after Vac 2: PMB80 [A22] 1:32 (N=794,801) |
66.9
6.7%
|
69.7
7%
|
| 1 month after Vac 2: PMB80 [A22] 1:64 (N=794,801) |
35.9
3.6%
|
35.8
3.6%
|
| 1 month after Vac 2: PMB80 [A22] 1:128 (N=794,801) |
11.0
1.1%
|
13.0
1.3%
|
| 1 month after Vac 3: PMB80 [A22] 1:4 (N=803,801) |
94.3
9.4%
|
96.4
9.7%
|
| 1 month after Vac 3: PMB80 [A22] 1:8 (N=803,801) |
94.3
9.4%
|
96.4
9.7%
|
| 1 month after Vac 3: PMB80 [A22] 1:32 (N=803,801) |
86.3
8.6%
|
87.0
8.7%
|
| 1 month after Vac 3: PMB80 [A22] 1:64 (N=803,801) |
58.0
5.8%
|
61.0
6.1%
|
| 1 month after Vac 3: PMB80 [A22] 1:128 (N=803,801) |
28.1
2.8%
|
31.6
3.2%
|
| Before Vaccination 1: PMB2001[A56] 1:4 (N=757,740) |
10.4
1%
|
10.5
1.1%
|
| Before Vaccination 1: PMB2001[A56] 1:16(N=757,740) |
9.0
0.9%
|
9.1
0.9%
|
| Before Vaccination 1: PMB2001[A56] 1:32(N=757,740) |
8.1
0.8%
|
7.7
0.8%
|
| Before Vaccination 1: PMB2001[A56] 1:64(N=757,740) |
4.9
0.5%
|
4.6
0.5%
|
| Before Vaccination 1:PMB2001[A56] 1:128(N=757,740) |
1.7
0.2%
|
1.5
0.2%
|
| 1 month after Vac 2: PMB2001 [A56] 1:4 (N=790,795) |
97.8
9.8%
|
98.7
9.9%
|
| 1 month after Vac 2: PMB2001[A56] 1:16 (N=790,795) |
97.2
9.7%
|
98.4
9.9%
|
| 1 month after Vac 2: PMB2001[A56] 1:32 (N=790,795) |
91.3
9.1%
|
93.7
9.4%
|
| 1 month after Vac 2: PMB2001[A56] 1:64 (N=790,795) |
71.6
7.2%
|
76.6
7.7%
|
| 1 month after Vac 2: PMB2001[A56] 1:128(N=790,795) |
40.4
4%
|
41.5
4.2%
|
| 1 month after Vac 3: PMB2001 [A56] 1:4 (n=796,802) |
99.1
9.9%
|
99.4
10%
|
| 1 month after Vac 3: PMB2001[A56] 1:16 (N=796,802) |
98.9
9.9%
|
99.4
10%
|
| 1 month after Vac 3: PMB2001[A56] 1:32 (N=796,802) |
96.7
9.7%
|
97.3
9.7%
|
| 1 month after Vac 3: PMB2001[A56] 1:64 (N=796,802) |
88.1
8.8%
|
89.2
8.9%
|
| 1 month after Vac 3: PMB2001[A56] 1:128(N=796,802) |
63.6
6.4%
|
67.2
6.7%
|
| Before Vaccination 1: PMB2948[B24] 1:4 (N=801,793) |
6.1
0.6%
|
8.4
0.8%
|
| Before Vaccination 1: PMB2948[B24] 1:16(N=801,793) |
4.1
0.4%
|
5.4
0.5%
|
| Before Vaccination 1: PMB2948[B24] 1:32(N=801,793) |
1.7
0.2%
|
3.0
0.3%
|
| Before Vaccination 1: PMB2948[B24] 1:64(N=801,793) |
0.6
0.1%
|
1.0
0.1%
|
| Before Vaccination 1:PMB2948[B24] 1:128(N=801,793) |
0.1
0%
|
0.5
0.1%
|
| 1 month after Vac 2: PMB2948 [B24] 1:4 (N=770,770) |
71.9
7.2%
|
77.1
7.7%
|
| 1 month after Vac 2: PMB2948[B24] 1:16 (N=770,770) |
65.2
6.5%
|
68.8
6.9%
|
| 1 month after Vac 2: PMB2948[B24] 1:32 (N=770,770) |
33.9
3.4%
|
38.7
3.9%
|
| 1 month after Vac 2: PMB2948[B24] 1:64 (N=770,770) |
13.1
1.3%
|
12.5
1.3%
|
| 1 month after Vac 2: PMB2948[B24] 1:128(N=770,770) |
5.3
0.5%
|
5.6
0.6%
|
| 1 month after Vac 3: PMB2948 [B24] 1:4 (N=788,793) |
91.1
9.1%
|
92.8
9.3%
|
| 1 month after Vac 3: PMB2948[B24] 1:16 (N=788,793) |
86.3
8.6%
|
89.2
8.9%
|
| 1 month after Vac 3: PMB2948[B24] 1:32 (N=788,793) |
57.2
5.7%
|
60.9
6.1%
|
| 1 month after Vac 3: PMB2948[B24] 1:64 (N=788,793) |
23.9
2.4%
|
25.2
2.5%
|
| 1 month after Vac 3: PMB2948[B24] 1:128(N=788,793) |
7.6
0.8%
|
8.4
0.8%
|
| Before Vaccination 1: PMB2707[B44] 1:4 (N=806,805) |
1.7
0.2%
|
3.2
0.3%
|
| Before Vaccination 1: PMB2707[B44] 1:16(N=806,805) |
1.2
0.1%
|
2.1
0.2%
|
| Before Vaccination 1: PMB2707[B44] 1:32(N=806,805) |
0.6
0.1%
|
1.4
0.1%
|
| Before Vaccination 1: PMB2707[B44] 1:64(N=806,805) |
0.1
0%
|
0.7
0.1%
|
| Before Vaccination 1:PMB2707[B44] 1:128(N=806,805) |
0.0
0%
|
0.2
0%
|
| 1 month after Vac 2: PMB2707 [B44] 1:4 (N=783,776) |
57.7
5.8%
|
60.1
6%
|
| 1 month after Vac 2: PMB2707[B44] 1:16 (N=783,776) |
46.4
4.6%
|
49.9
5%
|
| 1 month after Vac 2: PMB2707[B44] 1:32 (N=783,776) |
25.7
2.6%
|
26.9
2.7%
|
| 1 month after Vac 2: PMB2707[B44] 1:64 (N=783,776) |
11.2
1.1%
|
11.9
1.2%
|
| 1 month after Vac 2: PMB2707[B44] 1:128(N=783,776) |
5.0
0.5%
|
5.7
0.6%
|
| 1 month after Vac 3: PMB2707 [B44] 1:4 (N=799,795) |
84.4
8.4%
|
86.5
8.7%
|
| 1 month after Vac 3: PMB2707[B44] 1:16 (N=799,795) |
78.0
7.8%
|
82.4
8.3%
|
| 1 month after Vac 3: PMB2707[B44] 1:32 (N=799,795) |
57.7
5.8%
|
62.3
6.2%
|
| 1 month after Vac 3: PMB2707[B44] 1:64 (N=799,795) |
34.7
3.5%
|
39.4
3.9%
|
| 1 month after Vac 3: PMB2707[B44] 1:128(N=799,795) |
15.1
1.5%
|
18.4
1.8%
|
| Title | Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT) |
|---|---|
| Description | |
| Time Frame | Before Vaccination 1, 1 month after Vaccination 2, 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline |
|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 814 | 812 |
| Before Vaccination 1: PMB80 [A22] (N=794,799) |
9.6
|
9.9
|
| 1 month after Vac 2: PMB80 [A22] (N=794,801) |
31.9
|
33.7
|
| Before Vaccination 1: PMB2001 [A56] (N=757,740) |
5.0
|
5.0
|
| 1 month after Vac 2: PMB2001 [A56] (N=790,795) |
70.6
|
76.3
|
| 1 month after Vac 3: PMB2001 [A56] (N=796,802) |
117.2
|
128.2
|
| Before Vaccination 1: PMB2948 [B24] (N=801,793) |
4.3
|
4.5
|
| 1 month after Vac 2: PMB2948 [B24] (N=770,770) |
15.0
|
16.3
|
| Before Vaccination 1: PMB2707 [B44] (N=806,805) |
4.1
|
4.2
|
| 1 month after Vac 2: PMB2707 [B44] (N=783,776) |
11.1
|
11.9
|
| 1 month after Vac 3: PMB2707 [B44] (N=799,795) |
27.2
|
31.9
|
| Title | Percentage of Participants With at Least One Adverse Event (AE) |
|---|---|
| Description | |
| Time Frame | Vaccination 1 up to 1 month after Vaccination 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline | Group 3: Saline + Gardasil |
|---|---|---|---|
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule |
| Measure Participants | 992 | 990 | 501 |
| Number [percentage of participants] |
43.9
4.4%
|
41.7
4.2%
|
49.5
9.9%
|
Adverse Events
| Time Frame | 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) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Events collected on case report form were reported. | |||||
| Arm/Group Title | Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline | Group 3: Saline + Gardasil | |||
| Arm/Group Description | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule | Randomized to receive on a 0, 2-, 6- month schedule | |||
All Cause Mortality |
||||||
| Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline | Group 3: Saline + Gardasil | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline | Group 3: Saline + Gardasil | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/992 (1.2%) | 16/990 (1.6%) | 4/501 (0.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Lymphoid tissue hyperplasia | 1/992 (0.1%) | 0/990 (0%) | 0/501 (0%) | |||
| Cardiac disorders | ||||||
| Supraventricular tachycardia | 1/992 (0.1%) | 0/990 (0%) | 0/501 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain lower | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Haemorrhoids | 0/992 (0%) | 0/990 (0%) | 1/501 (0.2%) | |||
| Hepatobiliary disorders | ||||||
| Biliary dyskinesia | 0/992 (0%) | 0/990 (0%) | 1/501 (0.2%) | |||
| Infections and infestations | ||||||
| Appendicitis | 2/992 (0.2%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Cellulitis | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Burns first degree | 1/992 (0.1%) | 0/990 (0%) | 0/501 (0%) | |||
| Concussion | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Fibula fracture | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Humerus fracture | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Pelvic fracture | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Road traffic accident | 1/992 (0.1%) | 0/990 (0%) | 0/501 (0%) | |||
| Skull fracture | 1/992 (0.1%) | 0/990 (0%) | 0/501 (0%) | |||
| Tibia fracture | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Wrist fracture | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Epiphysiolysis | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Nodular fasciitis | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Nervous system disorders | ||||||
| Migraine | 1/992 (0.1%) | 0/990 (0%) | 1/501 (0.2%) | |||
| Hemiparesis | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Psychiatric disorders | ||||||
| Depression suicidal | 2/992 (0.2%) | 0/990 (0%) | 0/501 (0%) | |||
| Suicide attempt | 1/992 (0.1%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Affective disorder | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Anxiety | 1/992 (0.1%) | 0/990 (0%) | 0/501 (0%) | |||
| Bipolar disorder | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Cyclothymic disorder | 0/992 (0%) | 0/990 (0%) | 1/501 (0.2%) | |||
| Major depression | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
| Oppositional defiant disorder | 1/992 (0.1%) | 0/990 (0%) | 0/501 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 0/992 (0%) | 1/990 (0.1%) | 0/501 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Group 1: rLP2086 + Gardasil | Group 2: rLP2086 + Saline | Group 3: Saline + Gardasil | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 308/992 (31%) | 289/990 (29.2%) | 168/501 (33.5%) | |||
| Gastrointestinal disorders | ||||||
| Vomiting | 12/992 (1.2%) | 10/990 (1%) | 6/501 (1.2%) | |||
| Nausea | 15/992 (1.5%) | 6/990 (0.6%) | 2/501 (0.4%) | |||
| General disorders | ||||||
| Injection site pain | 50/992 (5%) | 43/990 (4.3%) | 21/501 (4.2%) | |||
| Pyrexia | 15/992 (1.5%) | 11/990 (1.1%) | 5/501 (1%) | |||
| Fatigue | 10/992 (1%) | 8/990 (0.8%) | 3/501 (0.6%) | |||
| Injection site swelling | 11/992 (1.1%) | 8/990 (0.8%) | 2/501 (0.4%) | |||
| Infections and infestations | ||||||
| Upper respiratory tract infection | 49/992 (4.9%) | 53/990 (5.4%) | 29/501 (5.8%) | |||
| Pharyngitis | 20/992 (2%) | 36/990 (3.6%) | 9/501 (1.8%) | |||
| Nasopharyngitis | 23/992 (2.3%) | 23/990 (2.3%) | 14/501 (2.8%) | |||
| Pharyngitis streptococcal | 18/992 (1.8%) | 14/990 (1.4%) | 15/501 (3%) | |||
| Gastroenteritis | 23/992 (2.3%) | 11/990 (1.1%) | 8/501 (1.6%) | |||
| Viral infection | 14/992 (1.4%) | 10/990 (1%) | 11/501 (2.2%) | |||
| Sinusitis | 18/992 (1.8%) | 11/990 (1.1%) | 5/501 (1%) | |||
| Gastroenteritis viral | 9/992 (0.9%) | 8/990 (0.8%) | 8/501 (1.6%) | |||
| Acute sinusitis | 5/992 (0.5%) | 13/990 (1.3%) | 6/501 (1.2%) | |||
| Otitis media | 11/992 (1.1%) | 9/990 (0.9%) | 2/501 (0.4%) | |||
| Pneumonia | 7/992 (0.7%) | 7/990 (0.7%) | 6/501 (1.2%) | |||
| Viral pharyngitis | 2/992 (0.2%) | 6/990 (0.6%) | 8/501 (1.6%) | |||
| Injury, poisoning and procedural complications | ||||||
| Ligament sprain | 16/992 (1.6%) | 20/990 (2%) | 10/501 (2%) | |||
| Joint injury | 12/992 (1.2%) | 5/990 (0.5%) | 2/501 (0.4%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 9/992 (0.9%) | 11/990 (1.1%) | 10/501 (2%) | |||
| Pain in extremity | 11/992 (1.1%) | 8/990 (0.8%) | 4/501 (0.8%) | |||
| Nervous system disorders | ||||||
| Headache | 50/992 (5%) | 38/990 (3.8%) | 21/501 (4.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 19/992 (1.9%) | 16/990 (1.6%) | 14/501 (2.8%) | |||
| Oropharyngeal pain | 12/992 (1.2%) | 23/990 (2.3%) | 6/501 (1.2%) | |||
| Nasal congestion | 10/992 (1%) | 12/990 (1.2%) | 7/501 (1.4%) | |||
| Asthma | 11/992 (1.1%) | 4/990 (0.4%) | 4/501 (0.8%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis contact | 13/992 (1.3%) | 10/990 (1%) | 10/501 (2%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01461993
Other Study ID Numbers:
- B1971011
- 6108A1-2007
First Posted:
Oct 28, 2011
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018