Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China

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NCT07710872 · readout in 572 d

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

Phase

Phase 3

Status

Not yet recruiting

Study type

Interventional

Design

Randomized · Quadruple · Prevention

Enrollment

4,568estimated

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

Date

Filed

Basis

What it is

Start

2026-08-20

estimated

When the study began enrolling

Primary completion

2028-03-13

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2029-07-26

estimated

The whole study's end, after follow-up

First posted

2026-07-17

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-17

actual

The 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: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA) — also filed as 395
Biological: Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)

Primary outcomes

what the primary-completion date above is the date OF

Participants 12 through 23 MoA (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

measured 30 days post 2nd vaccination (up to Day 121)

Participants 12 through 23 MoA (Cohort I): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W measured by rSBA

measured 30 days post 2nd vaccination (up to Day 121)

Participants 6 through 11 MoA (Cohort II): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

measured 30 days post 2nd vaccination (up to Day 121)

Participants 6 through 11 MoA (Cohort II): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

measured 30 days post 2nd vaccination (up to Day 121)

Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

measured Day 91

Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

measured Day 91

Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W

measured Day 151

Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA

measured Day 151

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