Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

NCT06284915 | Completed Phase 3 FDA Drug

• 3 other identifiers: MEQ000892023-508177-85U1111-1280-6981
• Study Type: interventional
• Target: 840
• Locations: 6 countries
• Sites: 45

Brief Summary

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

Conditions

Meningococcal Immunisation; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y

  Geometric mean titers after a 2-dose serie measured by serum bactericidal assays using human complement (hSBA)

  30 days after dose 2 (booster dose) (+14 days)

• Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA

  Vaccine seroresponse after a 2-dose serie measured by hSBA

  30 days after dose 2 (booster dose) (+14 days)

Secondary Outcomes (13)

• hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W and Y

  30 days after dose 1 (priming dose) (+14 days)

• hSBA antibody titers against meningococcal serogroups A, C, W and Y

  For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days)

• hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y

  For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days

• Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA

  For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days

• hSBA meningococcal serogroups A, C, W and Y vaccine seroresponse

  For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days

Study Arms (2)

Group 1: MenACYW conjugate vaccine

EXPERIMENTAL

Participants will receive MenACYW Conjugate Vaccine (MenQuadfi®): 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age (MenQuadfi®)

Biological: MenACYW conjugate vaccine

Group 2: Nimenrix®

ACTIVE COMPARATOR

Participants will receive Nimenrix®: 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age

Biological: MenACYW conjugate vaccine

Interventions

MenACYW conjugate vaccine BIOLOGICAL

Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection

Also known as: MenQuadfi®

Group 1: MenACYW conjugate vaccine

Eligibility Criteria

• Age: 6 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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(s) 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. A 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) and Meningococcal B vaccines) in the 4 weeks preceding the first and second study intervention administration or planned receipt of any vaccine (including COVID-19 and Meningococcal B vaccines) in the 4 weeks following any study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study interventions. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal A, C, W, or Y disease with either the trial vaccine or another vaccine (i.e., mono- or quadrivalent meningococcal conjugate vaccine) containing serogroups A, C, Y, or W.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (45)

Investigational Site Number : 2030002

České Budějovice, 370 06, Czechia

Location

Investigational Site Number: 2030001

České Budějovice, Czechia

Location

Investigational Site Number: 2030005

Prague, Czechia

Location

Investigational Site Number: 2080007

Aalborg, Denmark

Location

Investigational Site Number: 2080004

Aarhus, Denmark

Location

Investigational Site Number: 2080006

Herlev, Denmark

Location

Investigational Site Number : 2080005

Hjørring, 9800, Denmark

Location

Investigational Site Number: 2080002

Odense, Denmark

Location

Investigational Site Number: 2080001

Zeeland, Denmark

Location

Investigational Site Number: 2460005

Espoo, Finland

Location

Investigational Site Number: 2460002

Helsinki, Finland

Location

Investigational Site Number: 2460011

Helsinki, Finland

Location

Investigational Site Number: 2460006

Jaarvenpa, Finland

Location

Investigational Site Number : 2460003

Kokkola, 67100, Finland

Location

Investigational Site Number: 2460007

Oulu, Finland

Location

Investigational Site Number: 2460004

Tampere, Finland

Location

Investigational Site Number: 2460012

Turku, Finland

Location

Investigational Site Number: 2760007

Erfurt, Germany

Location

Investigational Site Number: 2760004

Herxheim, Germany

Location

Investigational Site Number: 2760003

Hürth, Germany

Location

Investigational Site Number: 2760001

Mönchengladbach, Germany

Location

Investigational Site Number: 2760011

Mönchengladbach, Germany

Location

Investigational Site Number: 2760005

Schönau am Königssee, Germany

Location

Investigational Site Number: 2760008

Schweigen-Rechtenbach, Germany

Location

Investigational Site Number: 2760010

Wolfsburg, Germany

Location

Investigational Site Number : 2760009

Worms, 67550, Germany

Location

Investigational Site Number : 6160001

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

Location

Investigational Site Number: 6160003

Bydgoszcz, Poland

Location

Investigational Site Number: 6160008

Bydgoszcz, Poland

Location

Investigational Site Number: 6160017

Bydgoszcz, Poland

Location

Investigational Site Number: 6160015

Krakow, Poland

Location

Investigational Site Number: 6160021

Krakow, Poland

Location

Investigational Site Number: 6160012

Luboń, Poland

Location

Investigational Site Number: 6160011

Siemianowice Śląskie, Poland

Location

Investigational Site Number: 6160007

Torun, Poland

Location

Investigational Site Number: 6160014

Trzebnica, Poland

Location

Investigational Site Number: 6160022

Warsaw, Poland

Location

Investigational Site Number: 6160010

Wroclav, Poland

Location

Investigational Site Number: 6160002

Wroclaw, Poland

Location

Investigational Site Number: 6160016

Łęczna, Poland

Location

Investigational Site Number: 6160004

Łomianki, Poland

Location

Investigational Site Number : 6420001

Bucharest, 011025, Romania

Location

Investigational Site Number : 6420003

Bucharest, 021105, Romania

Location

Investigational Site Number: 6420002

Bucharest, Romania

Location

Investigational Site Number: 6420005

Călăraşi, Romania

Location

Related Links

• MEQ00089 Plain Language Results Summary

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be performed in a modified double-blind fashion: * Investigators and study staff who conduct the safety assessment, and the participants parent/ legally acceptable representative will not know which study intervention is administered * Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: March 19, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CZ (3); FI (8); DE (9); DK (6); PL (15); RO (4)