Healthy
Conditions
Brief summary
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
Interventions
BIOLOGICALV132 Formulation 1
Experimental
BIOLOGICALV132 Formulation 2
Experimental
BIOLOGICALV132 Formulation 3
Experimental
BIOLOGICALPREVNAR 20™
Active Comparator
BIOLOGICALCAPVAXIVE™
Active Comparator
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination | 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 | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) | 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 | 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. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed