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

Healthy Volunteers Clinical Trial

Official title:

A Parallel-group, Prevention, Phase 3, 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284915
• Other study ID #: MEQ00089
• Secondary ID: MEQ000892023-508
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Meningococcal Immunisation

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