Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Meningococcal Infection; Healthy Volunteers

Treatments: Biological: MenACYW135 polysaccharide vaccine; Biological: MenACYW conjugate vaccine; Biological: MenAC conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07135986

U1111-1256-8979 (Registry Identifier)

MEQ00076

Details and patient eligibility

About

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.

Study details include:

• The study duration will be approximately 180 days.
• The vaccination visit will be Visit 1.
• The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.

Full description

The duration of each participant's participation will be approximately 180 days.

Enrollment: 1,602 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.)
• Participants who are healthy as determined by medical evaluation including medical history and physical examination.
• A female participant is eligible to participate if she is not pregnant or breastfeeding

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; or long-term systemic corticosteroid therapy
• History of meningococcal infection
• History of any neurologic disorders
• History of Guillain-Barré syndrome
• History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
• At high risk for meningococcal infection during the trial
• Known systemic hypersensitivity to any of the vaccine components
• Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
• Moderate or severe acute illness/infection
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination.
• The time since last vaccination of meningococcal vaccine was 2 years or less.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,602 participants in 4 patient groups

Group 1 MenACYW1-dose schedule

Experimental group

Description:

1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age

Treatment:

Biological: MenACYW conjugate vaccine

Group 2 MenACYW135 Ps 1-dose schedule

Active Comparator group

Description:

1 dose of MenACYW135 polysaccharide vaccine to participants aged 7 through 17 years of age

Treatment:

Biological: MenACYW135 polysaccharide vaccine

Group 3 MenACYW1-dose schedule

Experimental group

Description:

1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age

Treatment:

Biological: MenACYW conjugate vaccine

Group 4 Royal MenAC1-dose schedule

Active Comparator group

Description:

1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age

Treatment:

Biological: MenAC conjugate vaccine