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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Vaccines, Meningococcal Vaccines

Intervention / Treatment
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* Biological: rLP2086 and Gardasil
* Biological: rLP2086
* Biological: Gardasil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>rLP2086 + Gardasil | Biological: rLP2086 and Gardasil<br>* Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.<br>|
| Placebo Comparator: Group 2<br>rLP2086 and saline | Biological: rLP2086<br>* Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.<br>|
| Active Comparator: Group 3<br>Saline + Gardasil | Biological: Gardasil<br>* Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, rLP2086, Gardasil, HPV, meningitis B, N. meningitidis serogroup B, adolescents, single-blind, Meningococcal Vaccines