Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 6108A1-2007 | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | rLP2086 + Gardasil |
|
| Group 2 | Placebo Comparator | rLP2086 and saline |
|
| Group 3 | Active Comparator | Saline + Gardasil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rLP2086 and Gardasil | Biological | Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research Inc. | Daphne | Alabama | 36526 | United States | ||
| Radiant Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276263 | Derived | Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. | |
| 35164991 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: rLP2086 + Gardasil | Randomized to receive on a 0, 2-, 6- month schedule |
| FG001 | Group 2: rLP2086 + Saline | Randomized to receive on a 0, 2-, 6- month schedule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
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| rLP2086 | Biological | Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6. |
|
| Gardasil | Biological | Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6. |
|
| 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 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| The Children's Clinic of Jonesboro, PA | Jonesboro | Arkansas | 72401 | United States |
| Arkansas Pediatric Clinic | Little Rock | Arkansas | 72205 | United States |
| West Coast Clinical Trials, LLC | Cypress | California | 90630 | United States |
| Pediatric Care Medical Group | Huntington Beach | California | 92647 | United States |
| Loma Linda University Health Care - Moreno Valley Pediatrics | Moreno Valley | California | 92557 | United States |
| Bayview Research Group, LLC | Paramount | California | 90723 | United States |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | United States |
| California Research Foundation | San Diego | California | 92103 | United States |
| Bayview Research Group, LLC | Valley Village | California | 91607 | United States |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80907 | United States |
| Colorado Springs Family Practice | Colorado Springs | Colorado | 80909 | United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Pediatrics and Adolescent Medicine, PA | Marietta | Georgia | 30062 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Pediatrics and Adolescent Medicine | Woodstock | Georgia | 30189 | United States |
| Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| Northpoint Pediatrics, LLC | Indianapolis | Indiana | 46256 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
| Brownsboro Park Pediatrics | Louisville | Kentucky | 40207 | United States |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | United States |
| Allina Health Bandana Square Clinic | Saint Paul | Minnesota | 55108 | United States |
| Aspen Medical Group / Odyssey Research | Saint Paul | Minnesota | 55108 | United States |
| The Center for Pharmaceutical Research, PC | Kansas City | Missouri | 64114 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68504 | United States |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | United States |
| Clinical Research Center of Nevada | Henderson | Nevada | 89014 | United States |
| Clinical Research Center of Nevada | Henderson | Nevada | 89105 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89105 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Cary Pediatric Center | Cary | North Carolina | 27518 | United States |
| Duke University Medical Center - Duke Health Center | Durham | North Carolina | 27704 | United States |
| Durham Pediatrics | Durham | North Carolina | 27704 | United States |
| Duke Health Center | Durham | North Carolina | 27705 | United States |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | United States |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27612 | United States |
| Wake Internal Medicine Consultants, Inc | Raleigh | North Carolina | 27612 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Innovis Health, LLC dba Essentia Health South University Clinic | Fargo | North Dakota | 58103 | United States |
| Cincinnati Children's Hospital Medical Center (CCHMC) | Cincinnati | Ohio | 45206 | United States |
| Cincinnati Children's Hospital Medical Center (CCHMC) | Cincinnati | Ohio | 45229-3039 | United States |
| Senders Pediatrics | Cleveland | Ohio | 44121 | United States |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| Lynn Institute of Norman (LION) | Norman | Oklahoma | 73069 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center | Tulsa | Oklahoma | 74127 | United States |
| Oklahoma State University - Center for Health Sciences Houston Parke Physicians | Tulsa | Oklahoma | 74127 | United States |
| Preferred Primary Care Physicians, Inc. | Carnegie | Pennsylvania | 15106 | United States |
| Liberty Family Practice | Erie | Pennsylvania | 16508 | United States |
| Pennridge Pediatric Associates | Sellersville | Pennsylvania | 18960 | United States |
| Richard K. Ohnmacht, MD | Cranston | Rhode Island | 02920 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Charleston Pediatrics | Charleston | South Carolina | 29401 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| PMG Research of Charleston | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| The Office of Dr. Roberta Braun, MD | Austin | Texas | 78705 | United States |
| Advances In Health, Inc. | Houston | Texas | 77030 | United States |
| Pediatric Healthcare of Northwest Houston | Houston | Texas | 77070 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| University of Texas Medical Branch Pediatric Specialty Center | League City | Texas | 77573 | United States |
| Benchmark Research | San Angelo | Texas | 76904 | United States |
| Clinical Trials Of Texas, Inc | San Antonio | Texas | 78229 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| First Steps Pediatrics | San Antonio | Texas | 78229 | United States |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | United States |
| Pediatric Healthcare of Northwest Houston, PA | Tomball | Texas | 77375 | United States |
| Pediatric Healthcare of Northwest Houston | Tomball | Texas | 77375 | United States |
| Murray Pediatrics | Murray | Utah | 84107 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| Pediatric Associates of Charlottesville | Charlottesville | Virginia | 22902 | United States |
| West Office - Pediatric Associates of Charlottesville | Charlottesville | Virginia | 22903 | United States |
| North Office - Pediatric Associates of Charlottesville | Charlottesville | Virginia | 22911 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| Advanced Pediatrics | Vienna | Virginia | 22180 | United States |
| The Vancouver Clinic | Vancouver | Washington | 98664 | United States |
| The Vancouver Clinic | Vancouver | Washington | 98686 | United States |
| Monroe Clinic | Monroe | Wisconsin | 53566 | United States |
| Derived |
| Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11. |
| 32681472 | Derived | Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17. |
| FG002 | Group 3: Saline + Gardasil | Randomized to receive on a 0, 2-, 6- month schedule |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: rLP2086 + Gardasil | Randomized to receive on a 0, 2-, 6- month schedule |
| BG001 | Group 2: rLP2086 + Saline | Randomized to receive on a 0, 2-, 6- month schedule |
| BG002 | Group 3: Saline + Gardasil | Randomized to receive on a 0, 2-, 6- month schedule |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens | Posted | Geometric Mean | 95% Confidence Interval | titer | 1 month after Vaccination 3 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] | Posted | Geometric Mean | 95% Confidence Interval | titer | 1 month after Vaccination 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV) | Posted | Number | percentage of participants | 1 month after Vaccination 3 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants | Posted | Number | percentage of participants | Before vaccination 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | Posted | Number | percentage of participants | Before vaccination 1, 1 month after vaccination (Vac) 2, 3 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Posted | Number | percentage of participants | Before Vaccination 1, 1 month after Vaccination 2, 3 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT) | Posted | Geometric Mean | 95% Confidence Interval | titer | Before Vaccination 1, 1 month after Vaccination 2, 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With at Least One Adverse Event (AE) | Posted | Number | percentage of participants | Vaccination 1 up to 1 month after Vaccination 3 |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: rLP2086 + Gardasil | Randomized to receive on a 0, 2-, 6- month schedule | 12 | 992 | 308 | 992 | ||
| EG001 | Group 2: rLP2086 + Saline | Randomized to receive on a 0, 2-, 6- month schedule | 16 | 990 | 289 | 990 | ||
| EG002 | Group 3: Saline + Gardasil | Randomized to receive on a 0, 2-, 6- month schedule | 4 | 501 | 168 | 501 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Burns first degree | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nodular fasciitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cyclothymic disorder | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oppositional defiant disorder | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| C484699 | factor H-binding protein, Neisseria meningitidis |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
Not provided
Not provided
| 15 - <18 years |
|
| Male |
|
| HPV-16 |
|
| HPV-18 |
|
| GMT Ratio |
| 0.82 |
| 2-Sided |
| 95 |
| 0.74 |
| 0.91 |
| Non-Inferiority or Equivalence |
The non-inferiority criteria margin was 1.5-fold. |
| HPV-16 | GMT Ratio | 0.78 | 2-Sided | 95 | 0.68 | 0.88 | Non-Inferiority or Equivalence | The non-inferiority criteria margin was 1.5-fold. |
| HPV-18 | GMT Ratio | 0.71 | 2-Sided | 95 | 0.62 | 0.81 | Non-Inferiority or Equivalence | The non-inferiority criteria margin was 1.5-fold. |
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