A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
← catalyst calendarNCT07616934 · readout ≤ 499 d
Sponsored by Vaxcyte, Inc. (industry) · PCVX — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
80estimated
Sites
1
Country
Australia
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 | 2026-06-01 | 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 | 2026-06-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Group A Streptococcal Infection
Interventions
- Biological: Placebo
- Biological: VAX-A1 Low
- Biological: VAX-A1 Mid
- Biological: VAX-A1 High
Primary outcomes
what the primary-completion date above is the date OFFrequency of solicited local reactions (redness, swelling, and pain at injection site)
measured up to 7 days after each vaccination
Frequency of solicited systemic adverse events (AE) (fever, headache, fatigue, muscle pain, rash, joint pain, nausea/vomiting, diarrhea)
measured up to 7 days after each vaccination
Frequency of laboratory abnormalities identified from protocol-scheduled safety laboratory assessments at 7 days after each vaccination and reported as AE
measured 7 days after each vaccination
Frequency of unsolicited AE
measured up to 30 days after each vaccination
Frequency of medically attended AE (MAAE)
measured Up to 8 months after first vaccination
Frequency of new onset chronic illness (NOCI)
measured up to 8 months after the first vaccination
Frequency of serious adverse events (SAE)
measured from screening through up to 8 months after first vaccination
Occurrence of AE of special interest (AESI) (acute rheumatic fever [ARF], acute carditis [AC], and acute glomerulonephritis [AGN])
measured up to 8 months after the first vaccination
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