A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Biological: PREVNAR 20™; Biological: V118; Biological: Saline; Biological: V118C

Study type: Interventional

Funder types: Industry

Identifiers

NCT06611033

V118C-001

Details and patient eligibility

About

The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion criteria include but are not limited to the following:

• Is in good health before randomization

Exclusion Criteria:

• 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 a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 3 patient groups

V118C

Experimental group

Description:

Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29.

Treatment:

Biological: V118C

V118

Experimental group

Description:

Participants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29.

Treatment:

Biological: Saline

Biological: V118

PREVNAR 20™ + Saline

Active Comparator group

Description:

Participants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29.

Treatment:

Biological: Saline

Biological: PREVNAR 20™