NCT06720038Phase 2Active not recruiting

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-12Estimated

Enrollment · participants900Actual

Source updated2026-05-15Last update listed in the registry record

Version history

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Posted 2026-05-15 · 1 field changed

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Posted 2026-01-26 · 3 fields changed

Participant count type

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Recruitment status

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Study details

Conditions studied

Pneumococcal Vaccines

Treatments or interventions studied

0.5 mL of the low dose VAX-31Biological
0.5 mL of the mid dose VAX-31Biological
0.5 mL of the high dose VAX-31Biological
0.5 mL dose of PCV20Biological
0.5 mL of the High-PFS dose VAX-31Biological

Primary outcomes · main study measures

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measure: Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination; description: Solicited local reactions include erythema, edema, and tenderness at the injection site; timeFrame: 7 days after each vaccination; measure: Percentage of subjects with any solicited systemic AE within 7 days after each vaccination; description: Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep; timeFrame: 7 days after each vaccination; measure: Percentage of subjects with any unsolicited AE within 1 month after each vaccination; description: Percentage of subjects with unsolicited AE; timeFrame: 1 months after each vaccination; measure: Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination; description: Percentage of subjects with MAAE; timeFrame: 6 months after last vaccination; measure: Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination; description: Percentage of subjects with SAE; timeFrame: 6 months after last vaccination; measure: Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination; description: Percentage of subjects with NOCI; timeFrame: 6 months after last vaccination

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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