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NCT06284915

PHASE3

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

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

This study was conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study was 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 also described additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

Official title: A Parallel-group, Prevention, Phase III, Modified Double-blind, 2-arm, Study to Investigate the Immunogenicity and Describe the Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared With Nimenrix® When Administered in a 1+1 Schedule in Healthy Infants and Toddlers at 6 and 12 Months of Age

Key Details

Gender

All

Age Range

6 Months - 14 Months

Study Type

INTERVENTIONAL

Enrollment

840

Start Date

2024-03-19

Completion Date

2025-11-14

Last Updated

2026-10-07

Healthy Volunteers

Yes

Conditions

Meningococcal Immunisation Healthy Volunteers

Interventions

BIOLOGICAL

MenACYW conjugate vaccine

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

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

Inclusion Criteria: * Aged 6 to 7 months on the day of inclusion * Participants who were healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply: * 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.

Locations (45)

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

Calarasi, Romania

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (45)