A Study of V132 in Healthy Older Participants (V132-001)

Part of paid clinical trials in Anaheim, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07712575
Phase
PHASE1
Status
Recruiting

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • V132 Formulation 1 — BIOLOGICAL
    Experimental
  • V132 Formulation 2 — BIOLOGICAL
    Experimental
  • V132 Formulation 3 — BIOLOGICAL
    Experimental
  • PREVNAR 20™ — BIOLOGICAL
    Active Comparator
  • CAPVAXIVE™ — BIOLOGICAL
    Active Comparator

Study Details

The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.

Key Dates

First listed
Jul 17, 2026
Start date
Aug 12, 2026
Status verified
Aug 2026
Primary completion
Jun 21, 2028
Completion
Jun 21, 2028

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1: Dose Escalation
    Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
  • Experimental: Part 2: Dose Expansion
    Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.

Primary Outcome Measure

Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination [ Time Frame: Up to approximately 30 minutes post vaccination ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials ( Site 0006)AnaheimCalifornia92801
Study Coordinator
714-774-7777
Velocity Clinical Research, Hallandale Beach ( Site 0003)HallandaleFlorida33009
Study Coordinator
954-455-5757
Research Centers of America ( Hollywood ) ( Site 0009)HollywoodFlorida33024
Study Coordinator
954-990-7649
QPS-MRA, LLC-Early Phase ( Site 0001)South MiamiFlorida33143
Study Coordinator
305-722-0970
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)SpringfieldMissouri65802
Study Coordinator
417-831-2048
Velocity Clinical Research Lincoln ( Site 0007)LincolnNebraska68510
Study Coordinator
531-530-2800
Velocity Clinical Research, Omaha ( Site 0008)OmahaNebraska68134
Study Coordinator
402-933-6500
Remington-Davis, Inc. ( Site 0005)ColumbusOhio43215
Study Coordinator
614-487-2560
University of Texas Medical Branch ( Site 0004)League CityTexas77573
Study Coordinator
832-340-2313

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