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

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NCT07135986

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
1,602actual
Sites
4
Country
China

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-09-26actualWhen the study began enrolling
Primary completion2026-05-01actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-09-23estimatedThe whole study's end, after follow-up
First posted2025-08-22actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-12actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Meningococcal Infection
  • Healthy Volunteers

Interventions

  • Biological: MenACYW conjugate vaccine — also filed as MenQuadfi
  • Biological: MenACYW135 polysaccharide vaccine
  • Biological: MenAC conjugate vaccine

Primary outcomes

what the primary-completion date above is the date OF
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
measured 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
measured 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
measured 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
measured 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
measured 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
measured Day 01 (pre-vaccination) and Day 31 (post- vaccination)

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