Study

Overview

Official Title: A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation E in Healthy Adults

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.

Study Type:

Interventional

Study Phase:

Phase 1

Estimated Enrollment:

126

Study Start Date:

October 2025

Estimated Study Completion Date:

April 2027

Estimated Primary Completion Date:

April 2027

Eligibility

Ages Eligible for Study:

18 years to 49 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

CRITERIA

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

Locations

United States Toll Free Number 1-800-770-4674

Hallandale, Florida, 33009
South Miami, Florida, 33143
Galveston, Texas, 77555-1115

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results