A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
← catalyst calendarNCT06720038 · readout ≤ 499 d
Sponsored by Vaxcyte, Inc. (industry) · PCVX — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
900actual
Sites
48
Countries
Puerto Rico, United States
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 | 2024-11-25 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-12-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Pneumococcal Vaccines
Interventions
- Biological: 0.5 mL of the low dose VAX-31
- Biological: 0.5 mL of the mid dose VAX-31
- Biological: 0.5 mL of the high dose VAX-31
- Biological: 0.5 mL dose of PCV20
- Biological: 0.5 mL of the High-PFS dose VAX-31
Primary outcomes
what the primary-completion date above is the date OFPercentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination
measured 7 days after each vaccination
Percentage of subjects with any solicited systemic AE within 7 days after each vaccination
measured 7 days after each vaccination
Percentage of subjects with any unsolicited AE within 1 month after each vaccination
measured 1 months after each vaccination
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
measured 6 months after last vaccination
Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination
measured 6 months after last vaccination
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
measured 6 months after last vaccination
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