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

Last updated: September 24, 2024
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Completed

Phase

4

Condition

Healthy Volunteers

Meningococcal Infection

Treatment

MenACYW conjugate vaccine

Clinical Study ID

NCT05929651
MEQ00086
U1111-1277-6838
  • Ages 12-23
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 12 to 23 months on the day of inclusion

  • Participants who are healthy as determined by medical evaluation including medicalhistory, physical examination, and judgement of the Investigator

  • Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine duringinfancy before 12 months of age with an interval of at least 2 months between thelast vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose

Exclusion

Exclusion Criteria:

  • Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive 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 3months)

  • History of meningococcal infection, confirmed either clinically, serologically, ormicrobiologically

  • At high risk for meningococcal infection during the study (specifically but notlimited to participants with persistent complement deficiency, with anatomic orfunctional asplenia, or participants traveling to countries with high endemic orepidemic disease)

  • Personal history of Guillain-Barré syndrome

  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoidcontaining vaccine

  • Known systemic hypersensitivity to any of the study intervention components, orhistory of a life-threatening reaction to the study intervention used in the studyor to a product containing any of the same substances

  • Moderate or severe acute illness/infection (according to investigator judgment) orfebrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study interventionadministration. Prospective participant should not be included in the study untilthe condition has resolved or the febrile event has subsided

  • Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding thestudy intervention administration or planned receipt of any vaccine (includingCOVID-19 vaccines) in the 4 weeks following the study intervention administrationexcept for influenza vaccination, which may be received at least 2 weeks before or 2weeks after the study intervention. This exception includes monovalent pandemicinfluenza 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 firstblood draw

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Total Participants: 71
Treatment Group(s): 1
Primary Treatment: MenACYW conjugate vaccine
Phase: 4
Study Start date:
September 07, 2023
Estimated Completion Date:
September 09, 2024

Study Description

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

Connect with a study center

  • Investigational Site Number : 0320002

    Buenos Aires, Ciudad De Buenos Aires 1430
    Argentina

    Site Not Available

  • Investigational Site Number :0320002

    Buenos Aires, Ciudad De Buenos Aires 1430
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    Ciudad Autonoma Buenos Aires, C1425EFD
    Argentina

    Site Not Available

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