COMPLETED

A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001)

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to learn whether a new vaccine, V330, is safe and learn how well the body's immune system responds by making antibodies after receiving V330.

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older Participants (60 to 79 Years Inclusive).

Quick Facts

Study Start:2024-03-01
Study Completion:2025-10-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06630117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is in good health prior to randomization
  2. * Is an individual from 18 to 49 years of age inclusive or from 60 to 79 years of age inclusive
  1. * Has a history of myocarditis, pericarditis, and/or myopericarditis
  2. * Has a history of cancer

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

California Clinical Trials Medical Group managed by PAREXEL ( Site 0002)
Glendale, California, 91206
United States
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida, 33009
United States
Research Centers of America ( Hollywood ) ( Site 0004)
Hollywood, Florida, 33024
United States
QPS-MRA, LLC-Early Phase ( Site 0006)
South Miami, Florida, 33143
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2025-10-17

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2025-10-17

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy