A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

Study Overview
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Brief Summary
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This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.

Official Title
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A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE

Conditions
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Meningococcal Vaccine

Intervention / Treatment
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* Biological: MenABCWY
* Biological: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants 11 through <15 years of age at the time of randomization. Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization. Available for the entire study period and can be reached by telephone. Healthy participant as determined by medical history, physical examination, and judgement of the investigator. Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants. Exclusion Criteria: A previous anaphylactic reaction to any vaccine or vaccine-related component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. Significant neurological disorder or history of seizure (excluding simple febrile seizure). Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination. Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 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: Group 1 (MenABCWY 0-, 12-months)<br>MenABCWY administered at Month 0 and Month 12 | Biological: MenABCWY<br>* Neisseria meningitidis group A, B, C, W, and Y vaccine<br>* Other names: pentavalent meningococcal vaccine;|
| Experimental: Group 2 (MenABCWY 0-, 36-months)<br>MenABCWY administered at Month 0 and Month 36 | Biological: MenABCWY<br>* Neisseria meningitidis group A, B, C, W, and Y vaccine<br>* Other names: pentavalent meningococcal vaccine;Biological: Saline<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains | Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 12-month schedule | 1 month after second dose of MenABCWY in Group 1 | 
| Percentage of participants achieving an hSBA titer >= LLOQ for 4 primary MenB test strains | Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 36-month schedule | 1 month after second dose of MenABCWY in Group 2 | 
| Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the first MenABCWY vaccination | Describe frequency of AE, SAE, MAE, and NDCMC after first dose of MenABCWY | within 30 days after first MenABCWY vaccination | 
| Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the second MenABCWY vaccination | Describe frequency of AE, SAE, MAE, and NDCMC after second dose of MenABCWY | within 30 days after second MenABCWY vaccination | 
| Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the placebo vaccination in Group 2 | Describe frequency of AE, SAE, MAE, and NDCMC after placebo vaccination in Group 2 | within 30 days after placebo vaccination in Group 2 | 
| Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after any MenABCWY vaccination | Describe frequency of AE, SAE, MAE, and NDCMC after any dose of MenABCWY | within 30 days after any MenABCWY vaccination | 
| Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase | Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 1 vaccination phase | from Vaccination 1 through 1 month after Vaccination 1 | 
| Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 vaccination phase | Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 2 vaccination phase | from Vaccination 2 through 1 month after Vaccination 2 | 
| Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 3 vaccination phase in Group 2 | Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 3 vaccination phase in Group 2 | from Vaccination 3 through 1 month after Vaccination 3 in Group 2 | 
| Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 follow-up phase | Describe frequency of SAE, MAE, and NDCMC during the Vaccination 1 follow-up phase | from 1 month after Vaccination 1 through 6 months after Vaccination 1 | 
| Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 follow-up phase | Describe frequency of SAE, MAE, and NDCMC during the Vaccination 2 follow-up phase | from 1 month after Vaccination 2 through 6 months after Vaccination 2 | 
| Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 1 | Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 1 | from Vaccination 1 through 6 months after Vaccination 1 | 
| Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 2 | Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 2 | from Vaccination 2 through 6 months after Vaccination 2 | 
| Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 1 | Describe the frequency of immediate AE after Vaccination 1 | within 30 minutes after Vaccination 1 | 
| Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 2 | Describe the frequency of immediate AE after Vaccination 2 | within 30 minutes after Vaccination 2 | 
| Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 3 in Group 2 | Describe the frequency of immediate AE after Vaccination 3 in Group 2 | within 30 minutes after Vaccination 3 in Group 2 | 
| Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 1 | Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 1 | within 6 months after Vaccination 1 | 
| Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 2 | Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 2 | within 6 months after Vaccination 2 | 
| Percentage of participants reporting missed days of school or work due to adverse events within 1 month after Vaccination 3 in Group 2 | Describe frequency of missed days of school or work due to AEs within 1 month after Vaccination 3 in Group 2 | within 1 month after Vaccination 3 in Group 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain | Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 12-month schedule | 1 month after the first dose of MenABCWY in Group 1 | 
| Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain | Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 36-month schedule | 1 month after the first dose of MenABCWY in Group 2 | 
| Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain | Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule | 1 month after the second dose of MenABCWY in Group 1 | 
| Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain | Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 36-month schedule | 1 month after the second dose of MenABCWY in Group 2 | 
| Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains | Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule | 12 months after the second dose of MenABCWY in Group 1 | 
| Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains | Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule | 24 months after the second dose of MenABCWY in Group 1 | 
| Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain | Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule | 12 months after the second dose of MenABCWY in Group 1 | 
| Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain | Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule | 24 months after the second dose of MenABCWY in Group 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pentavalent meningococcal vaccine