Recruiting
Phase 1

V132

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07712575

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

V132 Formulation 1

V132 Formulation 2

V132 Formulation 3

PREVNAR 20™

CAPVAXIVE™

Study Details

Brief summary:

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

Conditions

Healthy

Study ID

NCT07712575

Start date

Aug 12, 2026

Status verified date

Aug, 2026

Completion date

Jun 21, 2028

Anticipated

Primary completion date

Jun 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

  • Is in good health
  • Has body mass index (BMI) within 18.0 to 35.0 kg/m\^2 (inclusive)

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination
  • Has received a pneumococcal polysaccharide vaccine in the previous 10 years, has received any pneumococcal conjugate vaccine at any time prior to this study

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

V132 Formulation 1

Experimental

V132 Formulation 2

Experimental

V132 Formulation 3

Experimental

PREVNAR 20™

Active Comparator

CAPVAXIVE™

Active Comparator

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 ]
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to approximately 7 days post vaccination ]
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to approximately 7 days post vaccination ]
  • Percentage of Participants With at Least 1 Unsolicited Adverse Event [ Time Frame: Up to approximately 28 days post vaccination ]
  • Percentage of Participants with a Serious Adverse Event [ Time Frame: Up to approximately 12 months post vaccination ]
  • Percentage of Participants With at Least 1 Medically Attended Adverse Event [ Time Frame: Up to approximately 12 months post vaccination ]
  • Percentage of Participants Who Experienced an Adverse Event of Clinical Interest [ Time Frame: Up to approximately 12 months post vaccination ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Anaheim Clinical Trials ( Site 0006)

Recruiting

Anaheim, California, United States, 92801

Contacts

Study Coordinator

714-774-7777

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Recruiting

Hallandale, Florida, United States, 33009

Contacts

Study Coordinator

954-455-5757

Research Centers of America ( Hollywood ) ( Site 0009)

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Study Coordinator

954-990-7649

QPS-MRA, LLC-Early Phase ( Site 0001)

Recruiting

South Miami, Florida, United States, 33143

Contacts

Study Coordinator

305-722-0970

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)

Recruiting

Springfield, Missouri, United States, 65802

Contacts

Study Coordinator

417-831-2048

Velocity Clinical Research Lincoln ( Site 0007)

Recruiting

Lincoln, Nebraska, United States, 68510

Contacts

Study Coordinator

531-530-2800

Velocity Clinical Research, Omaha ( Site 0008)

Recruiting

Omaha, Nebraska, United States, 68134

Contacts

Study Coordinator

402-933-6500

Remington-Davis, Inc. ( Site 0005)

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Study Coordinator

614-487-2560

University of Texas Medical Branch ( Site 0004)

Recruiting

League City, Texas, United States, 77573

Contacts

Study Coordinator

832-340-2313

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-02.