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

A Phase 1, Randomized, Double-Blind, Comparator-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V132 in Healthy Older Participants

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Biological: V132 Formulation 1; Biological: V132 Formulation 2; Biological: V132 Formulation 3; Biological: PREVNAR 20™; Biological: CAPVAXIVE™

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose Escalation; Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.	Biological: V132 Formulation 1; Experimental; Biological: V132 Formulation 2; Experimental; Biological: V132 Formulation 3; Experimental; Biological: PREVNAR 20™; Active Comparator; Biological: CAPVAXIVE™; Active Comparator
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.	Biological: V132 Formulation 1; Experimental; Biological: V132 Formulation 2; Experimental; Biological: V132 Formulation 3; Experimental; Biological: PREVNAR 20™; Active Comparator; Biological: CAPVAXIVE™; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with immediate reactions occurring within 30 minutes after any vaccination will be reported.	Up to approximately 30 minutes post vaccination
Percentage of Participants with a Solicited Injection-site Adverse Event	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. The percentage of participants with a solicited injection-site adverse event will be reported.	Up to approximately 7 days post vaccination
Percentage of Participants with a Solicited Systemic Adverse Event	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with a solicited systemic adverse event will be reported.	Up to approximately 7 days post vaccination
Percentage of Participants With at Least 1 Unsolicited Adverse Event	An unsolicited AE is an AE that was not solicited using a vaccination report card (VRC) and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs. The percentage of participants with at least 1 unsolicited adverse event will be reported.	Up to approximately 28 days post vaccination
Percentage of Participants with a Serious Adverse Event	A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs will be reported.	Up to approximately 12 months post vaccination
Percentage of Participants With at Least 1 Medically Attended Adverse Event	A medically attended adverse event (MAAE) is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The percentage of participants with at least 1 MAAE will be reported.	Up to approximately 12 months post vaccination
Percentage of Participants Who Experienced an Adverse Event of Clinical Interest	Events of clinical interest (ECIs) are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs). The percentage of participants who experienced an adverse event of clinical interest will be reported.	Up to approximately 12 months post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)	Opsonophagocytic activity (OPA) for serotypes in V132 formulations will be determined using a multiplexed opsonophagocytic assay (MOPA). Geometric Mean Titer (GMT) of serotype-specific OPA will be reported.	Up to approximately 28 days post vaccination
Geometric Mean Fold Rise from Baseline of Serotype-specific OPA	The Geometric Mean Fold Rise (GMFR) from baseline in serotype-specific OPA GMTs for serotypes in V132 formulations will be determined using a multiplexed opsonophagocytic assay (MOPA). GMFR is defined as the geometric mean of the ratio of concentration at Day 28 post vaccination divided by concentration at baseline.	Baseline (pre-vaccination) and 28 days post vaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): June 21, 2028
• Study Completion (Estimated): June 21, 2028

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: V132-001 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No