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A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)

Study acronym: ANCHOR
StatusActive, Not Recruiting
PhasePhase 3
Started2025-09-25
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Merck (MSD)

Amendment history

2026-09-18
Primary endpoint(s) modified1 entry, revised
WasPercentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
NowNumber of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Trial sites expanded: 181 → 362 locations
Interventions modified
2026-06-17
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment increased: 7500 → 10000 participants
Primary completion pushed: 2027-01 → 2027-06
Completion pushed: 2027-01 → 2027-06
Eligibility criteria+185 characters
[...] ≥ 18 kg/m^2 at screening. In the opinion of the Investigator or designee, must be able to comply with the requirements of the protoc [...] should not be enrolled. Must be assessed by the Investigator or designee as medically stable and not requiring significant change in [...] nificant medical event during the 2 months before screening MustFemale participants must agree to the following contraception requirements: a. Femal [...] ans to be contacted, and is able to contact the Investigator or designee/study site and communicate reliably during participation in [...] , and is otherwise healthy as determined by the Investig [...]
Secondary endpoints5 to 9 entries
Percentage of Stratum B Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug All-cause Hospitalization within 30 Days after the Onset of Symptomatic Influenza All-cause Mortality within 30 Days after the [...] Detection of Treatment-emergent Anti-Drug Antibodies (ADAs) in Participants Administered CD388 Detection of Treatment-boosted Anti-Drug Antibodies (ADAs) in Participants Administered CD388
Study sitesdetails revised at 181 of 181 sites
2026-05-29
Study Status, Contacts/Locations v11
Trial sites expanded: 176 → 181 locations
2026-05-22
Study Status, Contacts/Locations v10
Trial sites expanded: 157 → 176 locations
2026-05-18
Study Status, Contacts/Locations v9
Trial status changed: Active, Not Recruiting → Recruiting
Trial sites expanded: 150 → 157 locations
2026-04-19
Sponsor changed: Cidara Therapeutics Inc. → Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)+60 characters
WasCidara Therapeutics Inc.
NowCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2026-02-20
Study Status, Study Design v8
Enrollment target6000→7500
2025-12-20
Study Status, Eligibility v7
Eligibility criteria+353 characters
[...] ing Must agree to the following contraception requirements: a. Females of childbearing potential must use a highly effectiv [...] hs of amenorrhea, a single FSH measurement is insufficient. Male participants must agree to wear a condom when engaging in any activity that allows for passage of ejaculate to another person from Day 1 until 32 weeks after study intervention administration. Note: Contraceptive (birth control) use by participants shou [...] lobal Initiative for Asthma (GINA) Treatment Steps 3-5. Has a history ofexisting cardiac disease; specifically: Congenital heart disease Con [...] /or follow-up for i [...]
2025-12-10
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 150 of 150 sites
2025-11-20
Study Status, Contacts/Locations v5
Study sites149→150
2025-11-14
Study Status, Contacts/Locations v4
Study sites147→149
2025-11-07
Study Status, Contacts/Locations v3
Study sites145→147
2025-10-31
Study Status, Conditions, Contacts/Locations v2
Study sites114→145
2025-10-23
Not Yet Recruiting→Recruiting Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-09-25
Enrollment target5500→6000
Study sites15→114
Eligibility criteria+1,547 characters
[...] hs of amenorrhea, a single FSH measurement is insufficient. Female participants must agree not to donate or freeze eggs (ova, oocytes) for future use for the purposes of assisted reproduction from Day 1 until 32 weeks after study intervention administration. Male participants must agree to wear a condom when engaging [...] y 1 until 32 weeks after study intervention administration. Male participants who are partners of females of childbearing potential should also be advised of the benefit for female partners who are of childbearing potential to additionally use a highly effective method of contrace [...] [...]
2025-08-29
Original filing
Merck (MSD)
401 trials monitored
See 24 trials at risk
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). The goal of this study is to learn whether MK-1406 (CD388) can help prevent the flu in people who are at higher risk of becoming seriously ill from influenza. Researchers want to find out if MK-1406 dosed at a single study visit can provide protection against influenza compared with placebo. The study will include adolescents and adults who may be more vulnerable to complications from influenza because of their age, health conditions, or weakened immune systems. Researchers will also evaluate the safety of MK-1406 and how well participants tolerate the study medicine.
Trial Details
NCT Number NCT07159763
Lead Sponsor Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions Influenza
Enrollment 10,000 participants
Start Date 2025-09-25
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-17