A Study of V118E in Healthy Participants (V118E-003)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: Saline; Biological: PREVNAR 20™; Biological: V118E

Study type: Interventional

Funder types: Industry

Identifiers

NCT07168915

V118E-003

Details and patient eligibility

About

Researchers are looking for new vaccines to prevent illnesses caused by a type of bacteria called Streptococcus pneumoniae. There are many different types of Streptococcus pneumoniae bacteria, called serotypes. Vaccines contain small parts of certain serotypes. These parts will not cause an infection but help the body create antibodies (proteins) to fight the bacteria.

PREVNAR 20™ is a vaccine given to help to prevent disease from Streptococcus pneumoniae bacteria. Researchers designed a new vaccine, V118E, to help prevent disease from Streptococcus pneumoniae bacteria.

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

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

- Is in good health before randomization

Exclusion criteria

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

• 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, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

126 participants in 2 patient groups

V118E

Experimental group

Description:

Participants receive intramuscular (IM) injection of V118E in a 2-dose regimen administered on Day 1 and Day 29.

Treatment:

Biological: V118E

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: PREVNAR 20™

Biological: Saline