A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants

Study Overview
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Brief Summary
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The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Official Title
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A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE

Conditions
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Meningococcal Vaccine

Intervention / Treatment
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* Biological: MenABCWY
* Biological: Bivalent rLP2086 (60-µg Dose)
* Biological: Bivalent rLP2086 (120-µg Dose)
* Biological: Bexsero
* Drug: Prophylactic Liquid Paracetamol (PLP)
* Biological: Nimenrix
* Other: Placebo
* Drug: Scheduled Liquid Paracetamol (SLP)
* Drug: Therapeutic Liquid Paracetamol (TLP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants, 2 months of age (≥60 to ≤98 days) or 6 months of age (≥150 to ≤210 days) at the time of randomization. Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone. Healthy participant as determined by medical history, physical examination, and judgment of the investigator. Body weight ≥4 kg for participants 2 months of age at the time of randomization. Participants whose parent(s)/legal guardian are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Exclusion Criteria: Prior adverse reaction to paracetamol use, including allergic reactions. Participant was born prematurely (<37 weeks of gestation). 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. Please refer to the SRM for additional details. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae. Significant neurological disorder or history of seizure (including simple febrile seizure). Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Previous vaccination with any meningococcal vaccine. Written vaccination history must be obtained prior to randomization. For participants 2 months of age, prior vaccination with any of the following licensed or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or its component, except for the birth dose of hepatitis B vaccine. 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, before the first study vaccination. Current chronic use of systemic antibiotics. Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Months

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenABCWY with PLP - 6 months of age<br>Group 1 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 (2 primary vaccinations and a booster dose) schedule, and given Prophylactic Liquid Paracetamol (PLP) during primary vaccinations. | Biological: MenABCWY<br>* Neisseria meningitis groups A, B, C W, and Y vaccine<br>Drug: Prophylactic Liquid Paracetamol (PLP)<br>* PLP administration during primary vaccinations 1 and 2<br>|
| Experimental: MenABCWY - 6 months of age<br>Group 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule | Biological: MenABCWY<br>* Neisseria meningitis groups A, B, C W, and Y vaccine<br>|
| Experimental: Bivalent rLP2086 (60-µg Dose) and Nimenrix, with PLP or SLP - 2 months of age<br>Group 3 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP or Scheduled Liquid Pracetamol (SLP) during primary vaccinations. | Biological: Bivalent rLP2086 (60-µg Dose)<br>* Trumenba (half dose) - Meningococcal Group B vaccine<br>Drug: Prophylactic Liquid Paracetamol (PLP)<br>* PLP administration during primary vaccinations 1 and 2<br>Biological: Nimenrix<br>* Nimenrix - Meningococcal Group A, C, W and Y vaccine<br>Drug: Scheduled Liquid Paracetamol (SLP)<br>* SLP administration after primary vaccinations 1 and 2.<br>|
| Experimental: Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age<br>Group 4 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule | Biological: Bivalent rLP2086 (60-µg Dose)<br>* Trumenba (half dose) - Meningococcal Group B vaccine<br>Biological: Nimenrix<br>* Nimenrix - Meningococcal Group A, C, W and Y vaccine<br>|
| Experimental: Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age<br>Group 5 - Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations. | Biological: Bivalent rLP2086 (120-µg Dose)<br>* Trumenba - Meningococcal Group B vaccine<br>Drug: Prophylactic Liquid Paracetamol (PLP)<br>* PLP administration during primary vaccinations 1 and 2<br>Biological: Nimenrix<br>* Nimenrix - Meningococcal Group A, C, W and Y vaccine<br>|
| Experimental: MenABCWY with SLP - 2 months of age<br>Group 7 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given SLP during primary vaccinations. | Biological: MenABCWY<br>* Neisseria meningitis groups A, B, C W, and Y vaccine<br>Drug: Scheduled Liquid Paracetamol (SLP)<br>* SLP administration after primary vaccinations 1 and 2.<br>|
| Experimental: Bexsero and Nimenrix with PLP - 2 months of age<br>Group 8 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations | Biological: Bexsero<br>* Bexsero - Meningococcal Group B vaccine<br>Drug: Prophylactic Liquid Paracetamol (PLP)<br>* PLP administration during primary vaccinations 1 and 2<br>Biological: Nimenrix<br>* Nimenrix - Meningococcal Group A, C, W and Y vaccine<br>|
| Experimental: Bexsero and Nimenrix - 2 months of age<br>Group 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule | Biological: Bexsero<br>* Bexsero - Meningococcal Group B vaccine<br>Biological: Nimenrix<br>* Nimenrix - Meningococcal Group A, C, W and Y vaccine<br>|
| Experimental: MenABCWY with TLP - 2 months of age<br>Group 11 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with Therapeutic Liquid Paracetamol (TLP) during primary vaccinations. | Biological: MenABCWY<br>* Neisseria meningitis groups A, B, C W, and Y vaccine<br>Drug: Therapeutic Liquid Paracetamol (TLP)<br>* TLP administration after primary vaccinations 1 and 2<br>|
| Experimental: Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age<br>Group 13 - Participants 2 months of age vaccinated with MenABCWY and placebo on a 2+1 schedule, with a determined ratio of participants given SLP or TLP during primary vaccinations. | Biological: MenABCWY<br>* Neisseria meningitis groups A, B, C W, and Y vaccine<br>Other: Placebo<br>* Normal Saline<br>Drug: Scheduled Liquid Paracetamol (SLP)<br>* SLP administration after primary vaccinations 1 and 2.<br>Drug: Therapeutic Liquid Paracetamol (TLP)<br>* TLP administration after primary vaccinations 1 and 2<br>|
| Experimental: Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age<br>Group 14 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule with a determined ratio of participants given PLP or TLP during primary vaccinations. | Biological: Bexsero<br>* Bexsero - Meningococcal Group B vaccine<br>Drug: Prophylactic Liquid Paracetamol (PLP)<br>* PLP administration during primary vaccinations 1 and 2<br>Biological: Nimenrix<br>* Nimenrix - Meningococcal Group A, C, W and Y vaccine<br>Drug: Therapeutic Liquid Paracetamol (TLP)<br>* TLP administration after primary vaccinations 1 and 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants achieving an hSBA titer ≥ LLOQ (Lower Limit of Quantitation) for each MenA, MenC, MenW, and MenY test strain - Groups 7 and 11 combined versus Groups 8 and 10 combined | To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ for each MenA, MenC, MenW, and MenY test strain - Groups 7 and 11 combined versus Groups 8 and 10 combined | To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after a booster dose. | 1 month after the booster vaccination | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 7 and 11 combined versus Groups 8 and 10 combined | To describe the immune response for MenB induced by MenABCWY compared to the immune response induced by Bexsero after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 7 and 11 combined versus Groups 8 and 10 combined | To describe the immune response for MenB induced by MenABCWY compared to the immune response induced by Bexsero after a booster dose. | 1 month after the booster vaccination | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 3 and 4 combined versus Group 5 | To describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Groups 3 and 4 combined versus Group 5 | To describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after a booster dose. | 1 month after the booster vaccination | 
| The percentage of participants reporting local reactions after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen, and after the booster vaccination - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt, and after a booster dose. | With 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting systemic events after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen, and after the booster vaccination - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt, and after a booster dose. | With 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting antipyretics use after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen, and after the booster vaccination - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt, and after a booster dose. | With 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE (Serious Adverse Event) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 SAE (Serious Adverse Event) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 SAE by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 SAE by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 SAE by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE (Medically Attended Adverse Event) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 MAE (Medically Attended Adverse Event) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 MAE by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC (Newly Diagnosed Chronic Medical Condition) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 NDCMC by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 NDCMC by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 Adverse Event (AE) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 Adverse Event (AE) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 Adverse Event (AE) by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 immediate AE, by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after primary vaccinations with and without protocol-assigned paracetamol receipt. | Within 30 minutes after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt after primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE throughout the booster stage, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE throughout the booster stage, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC throughout the booster stage, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 AE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt during primary vaccinations - Groups 7 and 11 versus Groups 8 and 10 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ (Lower Limit of Quantitation) for each MenA, MenC, MenW, and MenY test strain - Group 13 versus Group 14 | To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ (Lower Limit of Quantitation) for each MenA, MenC, MenW, and MenY test strain - Group 13 versus Group 14 | To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after a booster dose. | 1 month after the booster vaccination | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Group 13 versus Group 14 | To describe the immune response for MenB induced by MenABCWY compared to the immune response induced by Bexsero after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the MenB test strains - Group 13 versus Group 14 | To describe the immune response for MenB induced by MenABCWY compared to the immune response induced by Bexsero after a booster dose. | 1 month after the booster vaccination | 
| hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains - Group 13 versus Group 14 | To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| hSBA GMTs for each of the MenB test strains - Group 13 versus Group 14 | To describe the immune response for each of MenB strains induced by MenABCWY compared to the immune response induced by Bexsero after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains - Group 13 versus Group 14 | To describe the immune response for MenA, MenC, MenW, and MenY induced by MenABCWY compared to the immune response induced by Nimenrix after the booster vaccination. | 1 month after the booster vaccination | 
| hSBA GMTs for each of the MenB test strains - Group 13 versus Group 14 | To describe the immune response for MenB induced by MenABCWY compared to the immune response induced by Bexsero after the booster vaccination. | 1 month after the booster vaccination | 
| The percentage of participants reporting local reactions after each primary vaccination, by protocol-assigned paracetamol regimen, and after the booster vaccination - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations, by protocol-assigned paracetamol receipt, and after a booster dose. | With 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting systemic events after each primary vaccination, by protocol-assigned paracetamol regimen, and after the booster vaccination - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations, by protocol-assigned paracetamol receipt, and after a booster dose. | With 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting use of antipyretic medication after each primary vaccination, by protocol-assigned paracetamol regimen, and after the booster vaccination - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations, by protocol-assigned paracetamol regimen receipt, and after a booster dose. | With 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen- Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol regimen receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 SAE within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 SAE from study entry through 1 month after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 SAE from 1 month through 8 months after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 SAE from study entry through 8 months after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 MAE within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 MAE from study entry through 1 month after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE from 1 month through 8 months after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE from study entry through 8 months after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 NDCMC within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 NDCMC from study entry through 1 month after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC from 1 month through 8 months after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC from study entry through 8 months after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 AE within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 AE within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 AE from study entry through 1 month after primary vaccination 2, by protocol-assigned paracetamol regimen - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 immediate AE within 30 minutes after each primary vaccination, by protocol-assigned paracetamol regimen, and after the booster vaccination - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after primary vaccinations by protocol-assigned paracetamol receipt. | Within 30 minutes after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol regimen receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE throughout the booster stage, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE throughout the booster stage, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC throughout the booster stage, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 AE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 13 versus Group 14 | To describe the safety profile of MenABCWY after a booster dose, regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hSBA GMTs (Geometric Mean Titer) for each of the MenB test strains - Groups 3 and 4 combined versus Group 5 | To further describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after 2 primary vaccinations. | 1 month after primary vaccination 2 | 
| hSBA GMTs for each of the MenB test strains - Groups 3 and 4 combined versus Group 5 | To further describe the immune response for MenB induced by 60 µg and 120 µg of bivalent rLP2086 after the booster vaccination. | 1 month after the booster vaccination | 
| The percentage of participants reporting local reactions after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt, and after the booster vaccination - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt, and after a booster dose. | Within 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting systemic events after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt, and after the booster vaccination - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt, and after a booster dose. | Within 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting antipyretics use after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen, and after the booster vaccination - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt, and after a booster dose. | Within 7 days after each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 SAE within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 SAE during the primary series vaccination phase, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 SAE during the primary series follow-up phase, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 SAE throughout the primary series stage, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 MAE within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 MAE during the primary series vaccination phase, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE during the primary series follow-up phase, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 MAE throughout the primary series stage, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 NDCMC within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 NDCMC during the primary series vaccination phase, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC during the primary series vaccination phase, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From 1 month through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 NDCMC throughout the primary series stage, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From study entry through 8 months after primary vaccination 2 | 
| The percentage of participants reporting at least 1 AE within 30 days after each primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after each primary vaccination | 
| The percentage of participants reporting at least 1 AE within 30 days after any primary vaccination, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | Within 30 days after any primary vaccination | 
| The percentage of participants reporting at least 1 AE during the primary series vaccination phase, by protocol-assigned paracetamol regimen and irrespective of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt. | From study entry through 1 month after primary vaccination 2 | 
| The percentage of participants reporting at least 1 immediate AE, by protocol-assigned paracetamol regimen and irrespective of paracetamol regimen, and after the booster vaccination - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary vaccinations, with and without protocol-assigned paracetamol receipt during primary vaccinations, and after a booster dose. | Within 30 minutes of each primary vaccination and after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 SAE throughout the booster stage, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 MAE throughout the booster stage, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC during the booster follow-up phase, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From 1 month through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 NDCMC throughout the booster stage, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 6 months after the booster vaccination | 
| The percentage of participants reporting at least 1 AE during the booster vaccination phase, regardless of protocol-assigned paracetamol receipt - Group 3, Group 4 and Group 5 | To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after a booster dose regardless of protocol-assigned paracetamol receipt during primary vaccinations. | From the booster vaccination through 1 month after the booster vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Meningococcal Vaccine, Invasive Meningococcal Disease, Meningococcal Serogroups A, B, C W and Y, MenABCWY Vaccine