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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers; Meningococcal Immunisation

Treatments: Biological: MenACYW conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05929651

MEQ00086

U1111-1277-6838 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 71 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

MenACYW conjugate vaccine

Experimental group

Description:

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

Treatment:

Biological: MenACYW conjugate vaccine