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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06284915
Other study ID # MEQ00089
Secondary ID MEQ000892023-508
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 19, 2024
Est. completion date March 11, 2025

Study information

Verified date April 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email Contact-US@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 840
Est. completion date March 11, 2025
Est. primary completion date March 10, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 14 Months
Eligibility 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: Participants are 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Czechia Investigational Site Number: 2030001 Ceske Budejovice
Czechia Investigational Site Number: 2030005 Prague
Denmark Investigational Site Number: 2080004 Aarhus
Finland Investigational Site Number: 2460006 Jaarvenpa
Finland Investigational Site Number: 2460007 Oulu
Finland Investigational Site Number: 2460004 Tampere
Finland Investigational Site Number: 2460012 Turku
Germany Investigational Site Number: 2760007 Erfurt
Germany Investigational Site Number: 2760001 Moenchengladbach
Germany Investigational Site Number: 2760005 Schoenau Am Koenigssee
Poland Investigational Site Number: 6160017 Bydgoszcz
Poland Investigational Site Number: 6160015 Krakow
Poland Investigational Site Number: 6160021 Krakow
Poland Investigational Site Number: 6160016 Leczna
Poland Investigational Site Number: 6160012 Lubon
Poland Investigational Site Number: 6160007 Torun
Poland Investigational Site Number: 6160014 Trzebnica
Poland Investigational Site Number: 6160010 Wroclav
Romania Investigational Site Number: 6420005 Calarasi

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Czechia,  Denmark,  Finland,  Germany,  Poland,  Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, Y and W 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)
Secondary hSBA antibody titers = 1:8 against meningococcal serogroups A, C, Y, and W % of participants achieving antibody titers measured by hSBA = predefined threshold of 1:8 30 days after dose 1 (priming dose) (+14 days)
Secondary hSBA antibody titers against meningococcal serogroups A, C, W, and Y Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs) 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)
Secondary hSBA antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers = predefined thresholds 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
Secondary 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 toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Secondary hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer = 1:16 and for a participant with a pre-vaccination titer = 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer 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
Secondary Rabbit complement (rSBA) 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
Secondary rSBA antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W 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
Secondary Percentage of Participants who achieved =4-fold rise in antibody titers over baseline measured by rSBA 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
Secondary rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer = 1:32 and for a participant with a pre-vaccination titer = 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer 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
Secondary Number of participants with immediate adverse events (AEs) Unsolicited systemic AEs that occur within 30 minutes after vaccination Within 30 minutes after each vaccination
Secondary Number of participants with solicited injection site reactions or systemic reactions Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF Within 7 days after each vaccination
Secondary Number of participants with unsolicited AEs AEs other than solicited reactions Up to 30 days after each vaccination
Secondary Number of participants with serious adverse events (SAEs) SAEs (including adverse events of special interest [AESIs]) reported throughout the study From baseline to up to 7 months
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