A Study of V132 in Healthy Older Participants (V132-001)
- Summary
- The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
- Short title
- A Study of V132 in Healthy Older Participants (V132-001)
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2028-06-21
- First posted
- 2026-07-17
- Registry last updated
- 2026-07-17
- Primary completion date
- 2028-06-21
- Start date
- 2026-08-17
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07712575
- ClinicalTrials.gov ID
- NCT07712575
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Basic science
- Masking
- Double masking
- Masked roles
- Participants, Investigators
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.
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.
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.
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.
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.
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.
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.
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.
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 50 Years
- Maximum age
- 75 Years
- Healthy volunteers
- Yes
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)
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
- Related resource (www.merckclinicaltrials.com)
Other registry identifiers
- V132-001