A Study of V132 in Healthy Older Participants (V132-001)

Condition(s) studied

Investigational drug(s) / intervention(s)

V132 Formulation 1: Experimental

V132 Formulation 2: Experimental

V132 Formulation 3: Experimental

PREVNAR 20™: Active Comparator

CAPVAXIVE™: Active Comparator

Study summary

The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (9)

More Merck Sharp & Dohme LLC trials in the USA

Other trials for the same condition