Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy

Study Overview
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Brief Summary
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This study will evaluate the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD). Participants will receive a single dose of MenQuadfi® at Visit 1. Participants will provide 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments. Study will include 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.

Detailed Description
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Study duration is approximately 30 days (+14 days) per participant

Official Title
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A Descriptive, Phase IV, Open-label, Single-arm Multi-center Study to Assess the Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Healthy Toddlers 12 to 23 Months of Age Who Had Been Primed With at Least 1 Dose of Another Quadrivalent Meningococcal Conjugate Vaccine, ie, Nimenrix® (MCV4-TT) or Menveo® (MCV4-CRM), in Infancy

Conditions
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Healthy Volunteers (Meningococcal Infection)

Intervention / Treatment
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* Biological: MenACYW conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 12 to 23 months on the day of inclusion Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose Exclusion Criteria: Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically At high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease) Personal history of Guillain-Barré syndrome Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. Prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine Receipt of immunoglobulins, blood or blood-derived products in the past 3 months Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw 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: 12 Months
Maximum Age: 23 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenACYW conjugate vaccine<br>participants will receive a single booster dose of the MenACYW conjugate vaccine with an interval of at least 2 months after the last vaccination with Nimenrix® or Menveo® received during infancy before 12 months of age | Biological: MenACYW conjugate vaccine<br>* Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection<br>* Other names: MenQuadfi®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W | % of participants achieving antibody titers measured by human complement (hSBA) ≥ predefined threshold of 1:8 | Day 31 (+14 days) after booster vaccination | 
| Number of participants with immediate adverse events (AEs) | Unsolicited systemic AEs that occur within 30 minutes after vaccination | Within 30 minutes after 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 booster vaccination | 
| Number of participants with unsolicited AEs | AEs other than solicited reactions | From Day 01 to Day 31 (+14 days) after booster vaccination | 
| Number of participants with serious adverse events (SAEs) | SAEs (including adverse events of special interest [AESIs]) reported throughout the study | From Day 01 to Day 31 (+14 days) after booster vaccination | 
| hSBA antibody titers against meningococcal serogroups A, C, Y, and W | Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs) | Day 01 and Day 31 (+14 days) after booster vaccination | 
| hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W | Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds | Day 01 and Day 31 (+14 days) after booster vaccination | 
| Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA |  | Day 01 and Day 31 (+14 days) after booster vaccination | 
| hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse | Vaccine seroresponse, defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:16 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer | Day 01 and Day 31 (+14 days) after booster vaccination | 
| Anti-tetanus antibody concentrations |  | Day 01 and Day 31 (+14 days) after booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W |  | Day 01 and Day 31 (+14 days) after booster vaccination | 
| rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W |  | Day 01 and Day 31 (+14 days) after booster vaccination | 
| Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA |  | Day 01 and Day 31 (+14 days) after booster vaccination | 
| rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse | Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:32 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer | Day 01 and Day 31 (+14 days) after booster vaccination |