A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Study Overview
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Brief Summary
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A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Official Title
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A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

Conditions
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Meningitis, Meningococcal

Intervention / Treatment
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* Biological: rLP2086 vaccine
* Biological: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects aged 10 to 25 years. Exclusion Criteria: Previous vaccination with Hepatitis A virus vaccine Previous vaccination with investigational meningococcal B vaccine History of culture-proven N. meningitidis serogroup B disease Any neuroinflammatory or autoimmune condition Any immune defect that would prevent an effective response to the study vaccine

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rLP2086 vaccine<br>rLP2086 vaccine | Biological: rLP2086 vaccine<br>* 120 mcg, 3 doses, at month 0, 2, and 6.<br>|
| Other: control<br>The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2. | Biological: control<br>* HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.<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 One Serious Adverse Event (SAE) Throughout the Study | An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. | Vaccination 1 up to 6 months after Vaccination 3 | 
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after Vaccination 1 | 
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after Vaccination 2 | 
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after Vaccination 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3) | 
| Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods | A medically attended AE was defined as a non-serious AE that required medical attention. | Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3) | 
| Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods | A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3) | 
| Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) | 
| Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. | Within 30 minutes after Vaccination 1, 2, 3 | 
| Number of Days Participant Missed School or Work Due to Adverse Events (AEs) |  | Vaccination 1 up to 1 month after Vaccination 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2, phase 3 safety study, 5700 healthy subjects, 3 vaccine doses at month 0, and 6, control HAV/saline/HAV