Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07712575

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Healthy

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V132 Formulation 1

Biological

Experimental

V132 Formulation 2

Biological

Experimental

V132 Formulation 3

Biological

Experimental

PREVNAR 20™

Biological

Active Comparator

CAPVAXIVE™

Biological

Active Comparator

Primary outcomes

  1. Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination

    Time frame: Up to approximately 30 minutes post 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.

  2. Percentage of Participants with a Solicited Injection-site Adverse Event

    Time frame: Up to approximately 7 days post vaccination

    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.

  3. Percentage of Participants with a Solicited Systemic Adverse Event

    Time frame: Up to approximately 7 days post vaccination

    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.

  4. Percentage of Participants With at Least 1 Unsolicited Adverse Event

    Time frame: Up to approximately 28 days post vaccination

    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.

  5. Percentage of Participants with a Serious Adverse Event

    Time frame: Up to approximately 12 months post vaccination

    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.

  6. Percentage of Participants With at Least 1 Medically Attended Adverse Event

    Time frame: Up to approximately 12 months post vaccination

    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.

  7. Percentage of Participants Who Experienced an Adverse Event of Clinical Interest

    Time frame: Up to approximately 12 months post vaccination

    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.

Secondary outcomes

  1. Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)

    Time frame: Up to approximately 28 days post vaccination

    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.

  2. Geometric Mean Fold Rise from Baseline of Serotype-specific OPA

    Time frame: Baseline (pre-vaccination) and 28 days post vaccination

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.