Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

Study Overview
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Brief Summary
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This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months

Official Title
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A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

Conditions
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Meningococcal Vaccine

Intervention / Treatment
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* Biological: Nimenrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1). Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation. Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent. Exclusion Criteria: Previous anaphylactic reaction to any vaccine or vaccine-related component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae. Significant neurological disorder or history of seizure (including simple febrile seizure). Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). Family history of congenital or hereditary immunodeficiency. Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Major known congenital malformation or serious chronic disorder. Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.

Ages Eligible for Study
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Minimum Age: 76 Days
Maximum Age: 104 Days

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimenrix<br>Nimenrix | Biological: Nimenrix<br>* MenACWY-TT vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants reporting local reactions within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. | 7 days | 
| The percentage of participants reporting systemic events within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. | 7 days | 
| The percentage of participants reporting the use of antipyretic medication within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. | 7 days | 
| The percentage of participants reporting at least 1 adverse event within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. | 30 days | 
| The percentage of participants reporting at least 1 immediate adverse event after Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. | 30 minutes | 
| The percentage of participants reporting at least 1 serious adverse event within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. | 30 days | 
| The percentage of participants reporting at least 1 newly diagnosed chronic medical condition within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. | 30 days | 
| Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Baseline | 
| Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 1 | 
| Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 9 | 
| Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age ) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 10 | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age) of Nimenrix | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Baseline | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 1 | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 9 | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants reporting local reactions within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 7 days | 
| The percentage of participants reporting systemic events within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 7 days | 
| The percentage of participants reporting the use of antipyretic medication within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 7 days | 
| The percentage of participants reporting at least 1 adverse event within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 30 days | 
| The percentage of participants reporting at least 1 immediate adverse event within 30 minutes after Dose 1 (Visit 1, 3 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 30 minutes | 
| The percentage of participants reporting at least 1 serious adverse event within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 30 days | 
| The percentage of participants reporting at least 1 serious adverse event from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 8 months | 
| The percentage of participants reporting at least 1 serious adverse event from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 9 months | 
| The percentage of participants reporting at least 1 newly diagnosed chronic medical condition within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 30 days | 
| The percentage of participants reporting at least 1 newly diagnosed chronic medical condition event from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 8 months | 
| The percentage of participants reporting at least 1 newly diagnosed chronic medical condition from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. | Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age | 9 months | 
| Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age | Baseline | 
| Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age | Month 1 | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age). | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Baseline | 
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Month 1 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:4 for each serogroup at baseline (Visit 1, 3 months of age). | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Baseline | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:4 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Month 1 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Baseline | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Month 1 | 
| hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age). | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Baseline | 
| hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Month 1 | 
| Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at baseline (Visit 1, 3 months of age). | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Baseline | 
| Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. | Month 1 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 for each serogroup at baseline (Visit 1, 3 months of age). | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Baseline | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 1 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 at Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 9 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 10 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Baseline | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 1 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 9 | 
| Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 10 | 
| hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 9 | 
| hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 10 | 
| Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 9 | 
| Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. | Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age. | Month 10 |