A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Prior Pneumococcal Vaccination
Vaxcyte, Inc.
Summary
The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Male or female ≥50 years of age (inclusive) at the time of randomization into the study. * Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed). * Able and willing to complete the informed consent process. * Available for clinical follow-up through the last study visit. * In good general health or with stable underlying chronic condition(s), as determined by medical history, oral…
Interventions
- Biological31-valent pneumococcal conjugate vaccine
0.5 mL of VAX-31 will be administered into the deltoid muscle
- BiologicalPCV20
0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Locations (30)
- Chinle Center for Indigenous HealthChinle, Arizona
- Avacare (CCT Research)Phoenix, Arizona
- Whiteriver Center for Indigenous HealthWhiteriver, Arizona
- Chase Medical ResearchWaterbury, Connecticut
- CenExel (RCA)Hollywood, Florida
- Eximia (Health Awareness)Jupiter, Florida