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

NCT07135986 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: MEQ00076U1111-1256-8979
• Study Type: interventional
• Target: 1,602
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Meningococcal Infection; Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

  30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8

  Day 01 (pre-vaccination) and Day 31 (post- vaccination)

• Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W

  Antibodies titers are expressed as geometric mean titers

  Day 31 (post- vaccination)

• Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine

  30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8

  Day 01 (pre-vaccination) and Day 31 (post- vaccination)

• Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C

  30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8

  Day 01 (pre-vaccination) and Day 31 (post- vaccination)

• Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C

  Antibody titers are expressed as geometric mean titers

  Day 01 (pre-vaccination) and Day 31 (post- vaccination)

• Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine

  30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8

  Day 01 (pre-vaccination) and Day 31 (post- vaccination)

Secondary Outcomes (9)

• Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1)

  Day 01 (pre-vaccination) and Day 31 (post- vaccination)

• Number of participants with immediate adverse events (AEs)

  Within 30 minutes post-vaccination

• Presence of solicited injection site reactions

  Within 7 days post-vaccination

• Presence of solicited systemic reactions

  Within 7 days post-vaccination

• Presence of unsolicited AEs

  Within 30 days post-vaccination

Study Arms (4)

Group 1 MenACYW1-dose schedule

EXPERIMENTAL

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

Biological: MenACYW conjugate vaccine

Group 2 MenACYW135 Ps 1-dose schedule

ACTIVE COMPARATOR

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

Biological: MenACYW135 polysaccharide vaccine

Group 3 MenACYW1-dose schedule

EXPERIMENTAL

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

Biological: MenACYW conjugate vaccine

Group 4 Royal MenAC1-dose schedule

ACTIVE COMPARATOR

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

Biological: MenAC conjugate vaccine

Interventions

MenACYW conjugate vaccine BIOLOGICAL

Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection

Also known as: MenQuadfi

Group 1 MenACYW1-dose schedule; Group 3 MenACYW1-dose schedule

MenACYW135 polysaccharide vaccine BIOLOGICAL

Pharmaceutical form: Lyophilized powder-Route of administration:IM injection

Group 2 MenACYW135 Ps 1-dose schedule

MenAC conjugate vaccine BIOLOGICAL

Pharmaceutical form:Lyophilized powder-Route of administration:IM injection

Group 4 Royal MenAC1-dose schedule

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

Investigational Site Number : 1561000

Nanning, Guangxi, 530028, China

Location

Investigational Site Number : 1561001

Jingxi, 533899, China

Location

Investigational Site Number : 1561003

Liuchow, 545100, China

Location

Investigational Site Number : 1561002

Tengzhou, 543399, China

Location

Related Links

• MEQ00076 Plain Language Results Summary

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and study staff as well as Sponsor study staff who conduct the safety assessment and the participant/parent/LAR will not know which study intervention is administered. Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: September 26, 2025
• Primary Completion: April 27, 2026
• Study Completion (Estimated): September 23, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (4)