Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

280

participants targeted

Target at P75+ for phase_1 healthy

Timeline

22mo left

Started Aug 2026

Longer than P75 for phase_1 healthy

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

July 14, 2026

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed

1 month until next milestone

Study Start

First participant enrolled

August 17, 2026

Expected

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2028

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

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
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

Secondary Outcomes (2)

Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)
Up to approximately 28 days post vaccination
Geometric Mean Fold Rise from Baseline of Serotype-specific OPA
Baseline (pre-vaccination) and 28 days post vaccination

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.

Biological: V132 Formulation 1Biological: V132 Formulation 2Biological: V132 Formulation 3Biological: PREVNAR 20™Biological: CAPVAXIVE™

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.

Biological: V132 Formulation 1Biological: V132 Formulation 2Biological: V132 Formulation 3Biological: PREVNAR 20™Biological: CAPVAXIVE™