Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
← catalyst calendarNCT06975878 · readout in 371 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
1,092actual
Sites
49
Countries
Belgium, Czechia, Estonia +5
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 | 2025-05-22 | actual | When the study began enrolling |
| Primary completion | 2027-08-25 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-08-25 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pneumococcal Immunization
- Healthy Volunteers
Interventions
- Biological: PCV21 vaccine — also filed as 515
- Biological: Vaxneuvance vaccine — also filed as Vaxneuvance ™
- Biological: Hexyon vaccine — also filed as Hexyon®
- Biological: M-M-RvaxPro vaccine — also filed as M-M-RVAX-PRO®
- Biological: Varivax vaccine — also filed as Varivax®
Primary outcomes
what the primary-completion date above is the date OFSeroresponse rate for PCV21 and 15vPCV serotypes
measured 30 days post-toddler dose
IgG concentration for PCV21 and 15vPCV serotypes
measured 30 days post-toddler dose
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