NCT07712575 · Merck Sharp & Dohme LLC
A Study of V132 in Healthy Older Participants (V132-001)
What this study is about
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
View original scientific description
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
Interventions
BIOLOGICAL
V132 Formulation 1
Experimental
BIOLOGICAL
V132 Formulation 2
Experimental
BIOLOGICAL
V132 Formulation 3
Experimental
BIOLOGICAL
PREVNAR 20™
Active Comparator
BIOLOGICAL
CAPVAXIVE™
Active Comparator
Primary outcome measures
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.
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.
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.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Anaheim, California
- Hallandale, Florida
- Hollywood, Florida
- South Miami, Florida
- Springfield, Missouri
- Lincoln, Nebraska
- Omaha, Nebraska
- Columbus, Ohio
- League City, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2026 · Source of record for eligibility and locations