Phase 4 N=71 Prevention

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

Meningococcal Immunisation · Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT05929651 ↗

Enrolled (actual)

Serious AEs

1.5%

Results posted

Sep 2025

Primary outcome: Primary: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W — 72.1; 100; 60.3; 100 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: MenACYW conjugate vaccine (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Sanofi Pasteur, a Sanofi Company
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W	72.1; 100; 60.3; 100; 67.7; 100	—
PRIMARY Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement	14.0; 244; 12.3; 1072; 14.0; 945	—
PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W	96.7; 100; 76.2; 100; 85.5; 100	—
PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination	91.1; 100; 96.1; 100	—
PRIMARY Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement	91.1; 100; 96.1; 100	—
PRIMARY Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA)	82.3; 4715; 11.6; 3676; 30.9; 5198	—
PRIMARY Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W	56.4; 54.5; 100; 100; 39.3; 24.6	—
PRIMARY Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination	83.3; 98.3; 98.3; 100	—
PRIMARY Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement	83.3; 98.3; 98.3; 100	—
PRIMARY Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid	0.642; 8.56	—
PRIMARY Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)	—	—
PRIMARY Number of Participants With Solicited Injection Site Reactions and Systemic Reactions	24; 35	—
PRIMARY Number of Participants With Unsolicited Adverse Events	23	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	1; 1	—

Summary

This study evaluated 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 received a single dose of MenQuadfi® at Visit 1. Participants provided 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments. Study included 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 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 was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05929651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.