Clinical trial NCT06630117: A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001)
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

* Is in good health prior to randomization
* Is an individual from 18 to 49 years of age inclusive or from 60 to 79 years of age inclusive

Exclusion Criteria:

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

* Has a history of myocarditis, pericarditis, and/or myopericarditis
* Has a history of cancer

Primary outcomes:
measure: Number of Participants with Solicited Injection Site Adverse Events (AEs)
timeFrame: Up to approximately 7 days after each vaccination
measure: Number of Participants with Solicited Systemic AEs
timeFrame: Up to approximately 7 days after each vaccination
measure: Number of Participants with Solicited Local AEs of Axillary Lymphadenopathy
timeFrame: Up to approximately 28 days after each vaccination
measure: Number of Participants with Immediate AEs Following Vaccinations
timeFrame: Up to approximately 30 minutes after each vaccination
measure: Number of Participants with Unsolicited AEs
timeFrame: Up to approximately 28 days after each vaccination
measure: Number of Participants with Serious AEs
timeFrame: Up to approximately 6 months after final vaccination
measure: Number of Participants with Medically Attended Adverse Events (MAAEs)
timeFrame: Up to approximately 6 months after final vaccination
measure: Number of Participants with Events of Clinical Interest (ECIs)
timeFrame: Up to approximately 6 months after final vaccination
Secondary outcomes:
measure: Geometric Mean Titers (GMT) of Histo-Blood Group Antigen (HBGA) Blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
timeFrame: Up to 28 days post vaccination
measure: GMT of IgG Antibodies Response Against Vaccine-matched NoV Genotypes
timeFrame: Up to 28 days post vaccination
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group managed by PAREXEL ( Site 0002)
state: California
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0003)
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood ) ( Site 0004)
state: Florida
city: South Miami
country: United States
facility: QPS-MRA, LLC-Early Phase ( Site 0006)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: