Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents

Study Overview
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Brief Summary
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The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents. The study duration will be up to 12 months for all participants.

Detailed Description
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The study duration will be approximately 12 months for all participants

Official Title
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A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).

Conditions
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Meningococcal Infection, Healthy Volunteers

Intervention / Treatment
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* Biological: Pentavalent Meningococcal ABCYW vaccine
* Biological: MenACYW conjugate vaccine
* Biological: Meningococcal group B vaccine
* Biological: Meningococcal group B vaccine
* Biological: Meningococcal group B vaccine
* Biological: MenACYW conjugate vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator. Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Known or suspected congenital or acquired immunodeficiency History of any Neisseria meningitidis infection At high risk for meningococcal infection during the study Individuals with active tuberculosis History of Guillain-Barré syndrome Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: MenPenta Formulation 1<br>Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo | Biological: Pentavalent Meningococcal ABCYW vaccine<br>* Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: MenPenta;Biological: Placebo<br>* Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)<br>|
| Experimental: Group 2: MenPenta Formulation 2<br>Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo | Biological: Pentavalent Meningococcal ABCYW vaccine<br>* Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: MenPenta;Biological: Placebo<br>* Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)<br>|
| Active Comparator: Group 3: Bexsero® + Menveo®<br>Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine | Biological: Meningococcal group B vaccine<br>* Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)<br>* Other names: Bexsero®;Biological: MenACYW conjugate vaccine<br>* Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)<br>* Other names: Menveo®;|
| Active Comparator: Group 4: Trumenba® + Menveo®<br>Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine | Biological: Meningococcal group B vaccine<br>* Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)<br>* Other names: Trumenba®;Biological: MenACYW conjugate vaccine<br>* Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)<br>* Other names: Menveo®;|
| Active Comparator: Group 5: MenQuadfi®<br>Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo | Biological: MenACYW conjugate vaccine<br>* Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)<br>* Other names: MenQuadFi®;Biological: Placebo<br>* Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)<br>|
| Experimental: Group 6: Sanofi MenB<br>Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo | Biological: Meningococcal group B vaccine<br>* Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: Sanofi MenB;Biological: Placebo<br>* Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with immediate adverse events (AEs) | Unsolicited systemic AEs that occur within 30 minutes after vaccination | Within 30 minutes after each vaccination | 
| Number of participants with solicited injection site reactions or systemic reactions | Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF | Within 7 days after each vaccination | 
| Number of participants with unsolicited AEs | AEs other than solicited reactions | Within 30 days after each vaccination | 
| Number of participants with serious adverse events (SAEs) | SAEs (including adverse events of special interest [AESIs]) reported throughout the study | From baseline up to 12 months | 
| Number of participants with medically attended adverse events (MAAEs) |  | From baseline up to 12 months | 
| Number of participants with out-of-range biological test results |  | Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group | 
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the last dose in adolescent participants | Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from D01 to post-vaccination for participants with pre-vaccination hSBA titers ≥ 1:8 | Day 01 (pre-dose) and Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, and 5) | 
| hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the last dose in adolescent participants | hSBA titers ≥ 1:8 post-vaccination (post-last dose) | Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, and 5) | 
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the last dose in adolescent participants | Geometric mean titers (pre-dose and post-last dose) | Day 01 (pre-dose) and Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, and 5) | 
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants |  | Day 01 (pre-dose) and Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, and 5) | 
| hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after last dose in adolescent participants | Seroresponse defined as a 4-fold increase in hSBA titers | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, and 6) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-last dose in adolescent participants | hSBA titers ≥ 1:4 for reference MenB strains | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, and 6) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-last dose in adolescent participants | hSBA titers ≥ 1:8 for reference MenB strains | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, and 6) | 
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants | Geometric mean titers (pre-dose and post-last dose) for the reference MenB strains | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, and 6) | 
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, and 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint | Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from Day 01 to post-vaccination for participants with pre-vaccination hSBA titers ≥ 1:8 | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group1 to 5) | 
| hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint | hSBA titers ≥ 1:8 post-vaccination (post-last dose) | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group1 to 5) | 
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint | Geometric mean titers (pre-dose and post-last dose) | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group1 to 5) | 
| Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint |  | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group1 to 5) | 
| hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint | Seroresponse defined as a 4-fold increase in hSBA titers | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, and 6) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, and 6) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint | hSBA titers ≥ 1:4 for reference MenB strains | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, and 6) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, and 6) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint | hSBA titers ≥ 1:8 reference MenB strains | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, and 6) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, and 6) | 
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint | Geometric mean titers (pre-dose and post-last dose) for reference MenB strains | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, and 6) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, and 6) | 
| Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint |  | Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, and 6) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, and 6) | 
| hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-last dose in adolescent participants | Seroresponse defined as a 4-fold increase in hSBA titers from D01 (pre-dose 1 administration) to post-vaccination (D211) for the additional MenB strains | Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-last dose in adolescent participants | hSBA titers ≥ 1:4 for additional MenB strains | Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-last dose in adolescent participants | hSBA titers ≥ 1:8 for additional MenB strains | Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6) | 
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants | Geometric mean titers (pre-dose and post-last dose) for additional MenB strains | Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6) | 
| Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ additional MenB strains in adolescent participants |  | Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6) | 
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the last dose in adult participants | Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from Day 01 to post-vaccination for participants with pre-vaccination hSBA titers ≥ 1:8 | Day 01 (pre-dose) and Day 211 (for Group 1, 2 and 5) or Day 31 (for Group 3, 4 and 5) | 
| hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the last dose in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2 and 5) or Day 31 (for Group 3, 4 and 5) | 
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the last dose in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2 and 5) or Day 31 (for Group 3, 4 and 5) | 
| Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2 and 5) or Day 31 (for Group 3, 4 and 5) | 
| hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after last dose in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-last dose in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3) | 
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-last dose in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3) | 
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-last dose in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3) | 
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adult participants |  | Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3) |