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

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
V118E 		Participants receive intramuscular (IM) injection of V118E in a 2-dose regimen administered on Day 1 and Day 29.
  • Biological: V118E
    IM administration
    Other names:
    • V118/VA-017
Active Comparator
PREVNAR 20™ + Saline 		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.
  • Biological: PREVNAR 20™
    IM administration
  • Biological: Saline
    IM administration

Recruiting Locations

University of Texas Medical Branch ( Site 0001)
Galveston 4692883, Texas 4736286 77555-1115
Contact:
Study Coordinator
409-772-5278

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com