Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
← catalyst calendarNCT06824194 · readout in 429 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
2,360actual
Sites
132
Countries
Honduras, Mexico, Puerto Rico +3
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 | 2025-02-18 | actual | When the study began enrolling |
| Primary completion | 2027-10-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-10-22 | estimated | The whole study's end, after follow-up |
| First posted | 2025-02-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Pneumococcal Immunization
Interventions
- Biological: PCV21 vaccine — also filed as 515
- Biological: Prevnar 20 vaccine — also filed as Prevnar20™
- Biological: M-M-R II vaccine — also filed as M-M-R™ II
- Biological: Rotarix — also filed as Rotarix™
- Biological: RotaTeq — also filed as RotaTeq™
- Biological: Vaxelis vaccine — also filed as Vaxelis™
- Biological: Varivax — also filed as Varivax™
- Biological: Priorix — also filed as Priorix™
- Biological: VAQTA — also filed as VAQTA™
- Biological: Havrix — also filed as Havrix™
Primary outcomes
what the primary-completion date above is the date OFPresence of any immediate adverse events (AEs)
measured Within 30 minutes after each vaccination
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
measured Through 7 days after each vaccine injection
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
measured Through 30 days after each vaccine injection
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
measured Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)
measured Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
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