Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination

Part of paid clinical trials in Chinle, Arizona.

Sponsor
Vaxcyte, Inc.
Study ID
NCT07425392
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Pneumococcal Vaccines

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 31-valent pneumococcal conjugate vaccine — BIOLOGICAL
    0.5 mL of VAX-31 will be administered into the deltoid muscle
  • PCV20 — BIOLOGICAL
    0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle

Study Details

The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.

Key Dates

Start date
Feb 9, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
752 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cohort 1 (VAX-31): Prior PPSV23
    Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1
  • Active Comparator: Cohort 1 (PCV20): Prior PPSV23
    Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1
  • Experimental: Cohort 2 (VAX-31): Prior PCV20
    Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1
  • Active Comparator: Cohort 2 (PCV20): Prior PCV20
    Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1
  • Experimental: Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combination
    Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1
  • Active Comparator: Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combination
    Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1

Primary Outcome Measure

Serotype-specific OPA geometric mean titers (GMT) [ Time Frame: 1 month after VAX-31 vaccination ]

Locations (30)

FacilityCityStateZIPSite coordinators
Chinle Center for Indigenous HealthChinleArizona86503-
Avacare (CCT Research)PhoenixArizona85044-
Whiteriver Center for Indigenous HealthWhiteriverArizona85941-
Chase Medical ResearchWaterburyConnecticut06708-
CenExel (RCA)HollywoodFlorida33024-
Eximia (Health Awareness)JupiterFlorida33458-
Eximia (Health Awareness)Port Saint LucieFlorida34952-
Precision Clinical ResearchSunriseFlorida33351-
The VillagesThe VillagesFlorida32162-
DelRicht Clinical ResearchStockbridgeGeorgia30281-
Velocity Clinical ValparaisoValparaisoIndiana46383-
Johnson County Clin-Trials, LLCLenexaKansas66219-
DelRicht Clinical ResearchNew OrleansLouisiana70115-
Velocity (Meridian Clinical Research)RockvilleMaryland20854-
DM Clinical Research-DetroitSouthfieldMichigan48076-
AMRKansas CityMissouri64114-
DelRicht Research (Command Family Medicine)SpringfieldMissouri65807-
Quality Clinical ResearchOmahaNebraska68114-
Center of American Indian HealthGallupNew Mexico87301-
Shiprock Center for Indigenous HealthShiprockNew Mexico87420-
Rochester Clinical Research, Inc.RochesterNew York14609-
Headlands (Trial Management Associates)WilmingtonNorth Carolina28403-
Tekton ResearchEdmondOklahoma73013-
DelRicht ResearchHendersonvilleTennessee37075-
Tekton ResearchAustinTexas78745-
REX Clinical TrialsBeaumontTexas77701-
Flourish ResearchSan AntonioTexas78229-
DM Clinical ResearchSugar LandTexas77478-
Alcanza (Charlottesville Medical Research)CharlottesvilleVirginia22911-
Health Research of Hampton Roads, Inc.Newport NewsVirginia23606-

Find similar trials in Chinle, AZ

By research site
Chinle Center for Indigenous Health· Chinle, AZAvacare (CCT Research)· Phoenix, AZWhiteriver Center for Indigenous Health· Whiteriver, AZChase Medical Research· Waterbury, CTCenExel (RCA)· Hollywood, FLEximia (Health Awareness)· Jupiter, FL