> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-v132-in-healthy-older-participants-v132-001-5b90c787-052e-49a2-968a-a19837fed2ab > Record changed: 2026-10-13 # A Study of V132 in Healthy Older Participants (V132-001) NCT07712575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) Participants 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) Start date 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Title and summary **Summary** The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Short title** A Study of V132 in Healthy Older Participants (V132-001) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Dates **Completion date** 2028-06-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **First posted** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Registry last updated** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Primary completion date** 2028-06-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Start date** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Size and sites **Participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Planned participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Identifiers **Registry ID** NCT07712575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **ClinicalTrials.gov ID** NCT07712575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Basic science **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Outcomes ### Primary outcomes 1. Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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) Timeframe: 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 Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Maximum age** 75 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers - V132-001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712575) ## Related records ### Drugs (3) - [Clofarabine](https://trialight.com/data/asset/clofarabine-df6136eb-4ce5-4462-8034-d6d6374f0221.md) - [Insulin efsitora alfa](https://trialight.com/data/asset/insulin-efsitora-alfa-9de5c01f-5ba8-4897-93f1-75044083ba25.md) - [Rotigaptide](https://trialight.com/data/asset/rotigaptide-bb594923-f30b-49ff-a57b-b85c7e052627.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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