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| ID | Type | Description | Link |
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| V132-001 | Other Identifier | MSD |
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The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V132 Formulation 1 | Biological | Experimental |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to approximately 28 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 28 days post vaccination |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
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| Merck Clinical Trials Information | View source |
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| V132 Formulation 2 | Biological | Experimental |
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| V132 Formulation 3 | Biological | Experimental |
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| PREVNAR 20™ | Biological | Active Comparator |
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| CAPVAXIVE™ | Biological | Active Comparator |
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| 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. | 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. | 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. | Up to approximately 12 months 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. |
| Baseline (pre-vaccination) and 28 days post vaccination |