A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Official Title
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A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years

Conditions
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Meningitis, Meningococcal

Intervention / Treatment
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* Biological: meningococcal B rLP2086 vaccine.
* Biological: meningococcal B rLP2086 vaccine.
* Biological: meningococcal B rLP2086 vaccine.
* Other: normal saline (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment. Negative urine pregnancy test for all female subjects. Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation. Exclusion Criteria: History of any invasive meningococcal disease. A previous anaphylactic or severe vaccine-associated adverse reaction. Any clinically significant chronic disease. A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 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
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>dose level 1 rLP2086 vaccine | Biological: meningococcal B rLP2086 vaccine.<br>* vaccine, 0.5 mL, 0 - 2 - 6 to 9 months<br>|
| Experimental: 2<br>dose level 2 rLP2086 vaccine | Biological: meningococcal B rLP2086 vaccine.<br>* vaccine, 0.5 mL, 0 - 2 - 6 to 9 months<br>|
| Experimental: 3<br>dose level 3 rLP2086 vaccine | Biological: meningococcal B rLP2086 vaccine.<br>* vaccine, 0.5 mL, 0 - 2 - 6 to 9 months<br>|
| Placebo Comparator: 4<br>normal saline (placebo) | Other: normal saline (placebo)<br>* vaccine, 0.5 mL, 0 - 2 - 6 to 9 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 |  | Before vaccination 1 up to 1 month after vaccination 2 | 
| Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 |  | Before vaccination 1 up to 1 month after vaccination 3 | 
| Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 |  | Vaccination 1 upto 1 Month after vaccination 3 | 
| Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 |  | 6 month after vaccination 3 up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level |  | 1 month before vaccination 1, 1 month after vaccination 2, 3 |