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Recruiting NCT07168915

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: V118E, PREVNAR 20™, Saline.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological V118E
    IM administration
  • Biological PREVNAR 20™
    IM administration
  • Biological Saline
    IM administration

Primary outcome measures

  • Number of Participants With Solicited Injection-Site Adverse Events (AEs) [Time frame: Up to approximately 7 days after each vaccination]
  • Number of Participants With Solicited Systemic AEs [Time frame: Up to approximately 7 days after each vaccination]
  • Number of Participants With Immediate AEs Following Vaccination [Time frame: Up to approximately 30 minutes after each vaccination]
  • Number of Participants With Unsolicited AEs [Time frame: Up to approximately 28 days after each vaccination]
  • Number of Participants With a Serious Adverse Event (SAE) [Time frame: Up to approximately 12 months after final vaccination]
  • Number of Participants With a Medically Attended Adverse Event (MAAE) [Time frame: Up to approximately 12 months after final vaccination]
  • Number of Participants With an Adverse Events of Special Interest (AESI) [Time frame: Up to approximately 12 months after final vaccination]
Secondary outcome measures (2)
  • Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) [Time frame: Day 28 Postvaccination 1]
  • Change From Baseline in Serotype-specific IgG GMCs [Time frame: Baseline and Day 28 Postvaccination 1]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 4 centers
  • Velocity Clinical Research, Hallandale Beach ( Site 0003) — Hallandale
  • QPS-MRA, LLC-Early Phase ( Site 0002) — South Miami
  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0004) — Springfield
  • University of Texas Medical Branch ( Site 0001) — Galveston

Identifiers

NCT: NCT07168915 · V118E-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗