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

Condition(s) studied

Investigational drug(s) / intervention(s)

Fluzone® High-Dose (HD) influenza vaccine: Fluzone® HD injectable suspension administered by intramuscular (IM) injection

MK-1406 Injection: MK-1406 liquid for injection administered subcutaneously

Placebo: MK-1406 matched liquid for SC injection

Study 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®

Eligibility

Primary outcome measure(s)

• Geometric Mean of Hemagglutinin Inhibition (HAI) Titers Against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® High-Dose (HD) and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo — Predose (Day 1), Day 15 and Day 29
  Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers (GMTs) will be summarized by treatment group and influenza strain.
• Percentage of Participants with Seroconversion Rates against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® HD and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo — Predose (Day 1), Day 15 and Day 29
  Seroconversion is defined as a 4-fold increase in influenza titer as measured by HAI assay at each visit compared to baseline. Seroconversion rates at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. Seroconversion rates will be summarized by treatment group and influenza strain.

Trial sites (2)

More Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials in the USA

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