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ACTIVE NOT RECRUITING
NCT07300085
PHASE1

A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)

Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

Summary

Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025). Yearly administration of an influenza vaccine for the prevention of influenza is currently recommended. However, the real-world vaccine effectiveness varied from 10% to 60% in the general population across the years of 2004 to 2024, with effectiveness in most years below 50% (CDC 2025) and decreasing to as low as 5% in immunocompromised individuals (Hughes 2021). Researchers are looking for other ways to prevent severe illness from the influenza virus. The goals of this study are to learn if: * MK-1406 (formerly CD388) is safe to take with Fluzone® * MK-1406 affects the immune response to Fluzone®

Official title: A Phase 1, Double-blind, Randomized Trial to Evaluate Safety and Immunogenicity of Fluzone® High-Dose Influenza Vaccine When Concomitantly Administered With CD388, a Novel Long-Acting Antiviral Conjugate for the Prevention of Influenza

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

710

Start Date

2025-11-08

Completion Date

2026-12-31

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Fluzone® High-Dose (HD) influenza vaccine

Fluzone® HD injectable suspension administered by intramuscular (IM) injection

COMBINATION_PRODUCT

MK-1406 Injection

MK-1406 liquid for injection administered subcutaneously

COMBINATION_PRODUCT

Placebo

MK-1406 matched liquid for SC injection

Locations (4)

California Clinical Trials Medical Group (CCTMG) managed by Parexel

Glendale, California, United States

Parexel ( Site 0001)

Glendale, California, United States

Parexel ( Site 0002)

Baltimore, Maryland, United States

Parexel International - EPCU Baltimore

Baltimore, Maryland, United States