HealthyPhase 1NCT07712575
A Study of V132 in Healthy Older Participants (V132-001)
A Phase 1 study testing V132 Formulation 1, V132 Formulation 2 and V132 Formulation 3 in people with Healthy, run by Merck Sharp & Dohme LLC at 10 sites in United States.
Trial summary
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V132 Formulation 1, V132 Formulation 2 and V132 Formulation 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Aug 2026to 5 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Anaheim Clinical Trials ( Site 0006)
Anaheim, California, 92801
Study Coordinator, 714-774-7777
- Recruiting
Remington-Davis, Inc. ( Site 0005)
Columbus, Ohio, 43215
Study Coordinator, 614-487-2560
- Recruiting
Velocity Clinical Research, Providence ( Site 0010)
East Greenwich, Rhode Island, 02818
Study Coordinator, 401-739-9350
- Recruiting
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida, 33009
Study Coordinator, 954-455-5757
- Recruiting
Research Centers of America ( Hollywood ) ( Site 0009)
Hollywood, Florida, 33024
Study Coordinator, 954-990-7649
- Recruiting
University of Texas Medical Branch ( Site 0004)
League City, Texas, 77573
Study Coordinator, 832-340-2313
- Recruiting
Velocity Clinical Research Lincoln ( Site 0007)
Lincoln, Nebraska, 68510
Study Coordinator, 531-530-2800
- Recruiting
Velocity Clinical Research, Omaha ( Site 0008)
Omaha, Nebraska, 68134
Study Coordinator, 402-933-6500
- Recruiting
QPS-MRA, LLC-Early Phase ( Site 0001)
South Miami, Florida, 33143
Study Coordinator, 305-722-0970
- Recruiting
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
Springfield, Missouri, 65802
Study Coordinator, 417-831-2048
About this study
Official 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
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
- Conditions
- Healthy
- Being tested
- V132 Formulation 1, V132 Formulation 2, V132 Formulation 3, PREVNAR 20™, CAPVAXIVE™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V132 Formulation 1Biological
Experimental
V132 Formulation 2Biological
Experimental
V132 Formulation 3Biological
Experimental
PREVNAR 20™Biological
Active Comparator
CAPVAXIVE™Biological
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels. Receives: Biological: V132 Formulation 1; Biological: V132 Formulation 2; Biological: V132 Formulation 3; Biological: PREVNAR 20™; Biological: CAPVAXIVE™ |
| Part 2: Dose Expansion | Experimental | 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. Receives: Biological: V132 Formulation 1; Biological: V132 Formulation 2; Biological: V132 Formulation 3; Biological: PREVNAR 20™; Biological: CAPVAXIVE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months post vaccination
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (pre-vaccination) and 28 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start12 Aug 2026
- Primary completion5 May 2028 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712575
- Sponsor's protocol ID
- V132-001
- Other IDs
- V132-001
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07712575
- Acronym / sponsor ID
- V132-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 5 May 2028 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Biological: V132 Formulation 1, Biological: V132 Formulation 2, Biological: V132 Formulation 3, Biological: PREVNAR 20™, Biological: CAPVAXIVE™Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels. |
| Part 2: Dose Expansion | Experimental | Biological: V132 Formulation 1, Biological: V132 Formulation 2, Biological: V132 Formulation 3, Biological: PREVNAR 20™, Biological: CAPVAXIVE™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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is in good health
- Has body mass index (BMI) within 18.0 to 35.0 kg/m^2 (inclusive)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V132 Formulation 1Experimental | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
| V132 Formulation 2Experimental | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
| V132 Formulation 3Experimental | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
| PREVNAR 20™Active Comparator | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
| CAPVAXIVE™Active Comparator | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
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.
2 secondary outcomes
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)
Time frame: Up to approximately 28 days post vaccination
Geometric Mean Fold Rise from Baseline of Serotype-specific OPA
Time frame: Baseline (pre-vaccination) and 28 days post vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V132 Formulation 1, V132 Formulation 2 and V132 Formulation 3 in people with Healthy, run by Merck Sharp & Dohme LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.