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

NCT ID: NCT06284915

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 840 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2025-11-14

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.

Detailed Description

The study duration will be approximately 7 to 8.5 months (at least 7 months per participant).

Conditions

Meningococcal Immunisation; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group 1: MenACYW conjugate vaccine

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®)

Group Type: EXPERIMENTAL

MenACYW conjugate vaccine

Intervention Type: BIOLOGICAL

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

Group 2: Nimenrix®

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

Group Type: ACTIVE_COMPARATOR

MenACYW conjugate vaccine

Intervention Type: BIOLOGICAL

Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection

Interventions

MenACYW conjugate vaccine

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

Intervention Type: BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection

Intervention Type: BIOLOGICAL

Other Intervention Names

MenQuadfi®; Nimenrix®

Eligibility Criteria

Inclusion Criteria

• Aged 6 to 7 months on the day of inclusion
• Participants who are healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator

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(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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational Site Number : 2030002

České Budějovice, , Czechia

Investigational Site Number: 2030001

České Budějovice, , Czechia

Investigational Site Number: 2030005

Prague, , Czechia

Investigational Site Number: 2080007

Aalborg, , Denmark

Investigational Site Number: 2080004

Aarhus, , Denmark

Investigational Site Number: 2080006

Herlev, , Denmark

Investigational Site Number : 2080005

Hjørring, , Denmark

Investigational Site Number: 2080002

Odense, , Denmark

Investigational Site Number: 2080001

Zeeland, , Denmark

Investigational Site Number: 2460005

Espoo, , Finland

Investigational Site Number: 2460002

Helsinki, , Finland

Investigational Site Number: 2460011

Helsinki, , Finland

Investigational Site Number: 2460006

Jaarvenpa, , Finland

Investigational Site Number : 2460003

Kokkola, , Finland

Investigational Site Number: 2460007

Oulu, , Finland

Investigational Site Number: 2460004

Tampere, , Finland

Investigational Site Number: 2460012

Turku, , Finland

Investigational Site Number: 2760007

Erfurt, , Germany

Investigational Site Number: 2760004

Herxheim, , Germany

Investigational Site Number: 2760003

Hürth, , Germany

Investigational Site Number: 2760001

Mönchengladbach, , Germany

Investigational Site Number: 2760011

Mönchengladbach, , Germany

Investigational Site Number: 2760005

Schönau am Königssee, , Germany

Investigational Site Number: 2760008

Schweigen-Rechtenbach, , Germany

Investigational Site Number: 2760010

Wolfsburg, , Germany

Investigational Site Number : 2760009

Worms, , Germany

Investigational Site Number : 6160001

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number: 6160003

Bydgoszcz, , Poland

Investigational Site Number: 6160008

Bydgoszcz, , Poland

Investigational Site Number: 6160017

Bydgoszcz, , Poland

Investigational Site Number: 6160015

Krakow, , Poland

Investigational Site Number: 6160021

Krakow, , Poland

Investigational Site Number: 6160012

Luboń, , Poland

Investigational Site Number: 6160011

Siemianowice Śląskie, , Poland

Investigational Site Number: 6160007

Torun, , Poland

Investigational Site Number: 6160014

Trzebnica, , Poland

Investigational Site Number: 6160022

Warsaw, , Poland

Investigational Site Number: 6160010

Wroclav, , Poland

Investigational Site Number: 6160002

Wroclaw, , Poland

Investigational Site Number: 6160016

Łęczna, , Poland

Investigational Site Number: 6160004

Łomianki, , Poland

Investigational Site Number : 6420001

Bucharest, , Romania

Investigational Site Number : 6420003

Bucharest, , Romania

Investigational Site Number: 6420002

Bucharest, , Romania

Investigational Site Number: 6420005

Călăraşi, , Romania

Countries

Czechia; Denmark; Finland; Germany; Poland; Romania

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25619&tenant=MT_SNY_9011

MEQ00089 Plain Language Results Summary

Other Identifiers

2023-508177-85

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1280-6981

Identifier Type: REGISTRY

Identifier Source: secondary_id

MEQ00089

Identifier Type: -

Identifier Source: org_study_id