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A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine with 5- and/or 10-year Booster Doses in Children and Adolescents who had been Primed with MenACYW Conjugate Vaccine as Toddlers

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510145-25-00
Acronym
MEQ00073
Enrollment
209
Registered
2024-05-01
Start date
2022-08-23
Completion date
Unknown
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal infection

Brief summary

Vaccine seroresponse against meningococcal serogroups A, C, W, and Y

Detailed description

Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine (Group 1 and 2), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 (Group 2), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 (Group 1), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 1 and Visit 2 (Group 1), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 and Visit 3 (Group 2), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 and Visit 4 (Group 1), Antibody concentrations against tetanus toxoid at Visit 1 and Visit 2 (Group 1), Antibody concentrations against tetanus toxoid at Visit 3 and Visit 4 (Group 1), Antibody concentrations against tetanus toxoid at Visit 2 and Visit 3 (Group 2), Antibody titers against meningococcal serogroup C Visit 3 and Visit 4 (Group 1), Antibody titers against meningococcal serogroup C Visit 2 and Visit 3 (Group 2), Number of participants with immediate unsolicited systemic adverse events (AEs), Number of participants with solicited injection site reactions and systemic reactions, Number of participants with unsolicited AEs, Number of participants with serious adverse events (SAEs) and Adverse Event of Special Interest (AESI)

Interventions

Sponsors

Sanofi Pasteur, Sanofi Pasteur
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Vaccine seroresponse against meningococcal serogroups A, C, W, and Y

Secondary

MeasureTime frame
Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine (Group 1 and 2), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 (Group 2), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 (Group 1), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 1 and Visit 2 (Group 1), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 and Visit 3 (Group 2), Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 and Visit 4 (Group 1), Antibody concentrations against tetanus toxoid at Visit 1 and Visit 2 (Group 1), Antibody concentrations against tetanus toxoid at Visit 3 and Visit 4 (Group 1), Antibody concentrations against tetanus toxoid at Visit 2 and Visit 3 (Group 2), Antibody titers against meningococcal serogroup C Visit 3 and Visit 4 (Group 1), Antibody titers against meningococcal serogroup C Visit

Countries

Finland, Germany, Hungary, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026