A Clinical Trial of V175 and V175A in Healthy Adults

NCT07855510 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: V175-001
• Study Type: interventional
• Target: 564
• Locations: 0 countries
• Sites: N/A

Brief Summary

Researchers are looking for new vaccines to prevent lower respiratory tract infections. A lower respiratory tract infection is an infection in the lower part of the airways and/or the lungs. Respiratory syncytial virus (RSV), amongst other respiratory viruses, can cause these infections. This trial will look at the RSV multivalent vaccines V175 and V175A in healthy participants. The goal of the trial is to learn about the safety of V175 and V175A and if participants tolerate them.

Conditions

Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With Immediate Reactions After Vaccination

  The percentage of participants with immediate reactions after vaccination will be reported.

  Up to approximately 30 minutes after vaccination

• Percentage of Participants With a Solicited Injection-Site Adverse Event

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with a solicited injection-site AE (ie, pre-listed in the participant's diary) will be reported.

  Up to approximately 7 days after vaccination

• Percentage of Participants With a Solicited Systemic Adverse Event

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants with a solicited systemic AE (ie, pre-listed in the participant's diary) will be reported.

  Up to approximately 7 days after vaccination

• Percentage of Participants With an Unsolicited Adverse Event

  An unsolicited AE is an AE that was not solicited using a vaccination report card and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs. The percentage of participants with an unsolicited adverse event will be reported.

  Up to approximately 28 days after vaccination

• Percentage of Participants With a Serious Adverse Event (SAE)

  An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The percentage of participants with a SAE will be reported.

  Up to approximately 12 months after vaccination

• Percentage of Participants With a Medically Attended Adverse Event (MAAE)

  MAAEs are defined as adverse events in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. The percentage of participants with a MAAE will be reported.

  Up to approximately 12 months after vaccination

• Percentage of Participants With an Adverse Event of Special Interest (AESI) Including Potential Immune-Mediated Diseases (pIMDs)

  AESIs are selected serious and nonserious AEs which include but are not limited to pIMDs defined as a subset of AEs that includes both: established autoimmune disease(s) and inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The percentage of participants with an AESI will be reported.

  Up to approximately 12 months after vaccination

Secondary Outcomes (1)

• Geometric Mean Ratio (GMR) of Anti-Respiratory Syncytial Virus-A (RSV-A) Neutralizing Antibodies Elicited by V175/V175A Relative to Control Vaccine

  Up to approximately 28 days after vaccination

Study Arms (4)

V175

EXPERIMENTAL

Participants will receive a single intramuscular (IM) vaccination of V175 on Day 1.

Biological: V175

V175A

EXPERIMENTAL

Participants will receive a single IM vaccination of V175A on Day 1.

Biological: V175A

Control Vaccine

ACTIVE COMPARATOR

Participants will receive a single IM vaccination of control vaccine on Day 1.

Biological: Control Vaccine

Placebo

PLACEBO COMPARATOR

Participants will receive a single IM vaccination of placebo on Day 1.

Other: Placebo

Interventions

V175 BIOLOGICAL

Intramuscular administration

V175

V175A BIOLOGICAL

Intramuscular administration

V175A

Control Vaccine BIOLOGICAL

Intramuscular administration

Control Vaccine

Placebo OTHER

Intramuscular administration

Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is in good health
• Is an individual of any sex/gender, from 18 years to 49 years of age inclusive, or 60 years to 84 years of age inclusive
• Has a body mass index between 18 and 35 kg/m\^2, inclusive

You may not qualify if:

• Has a history of cancer (malignancy)
• Has any known or suspected autoimmune disease or immunosuppressive condition, acquired or congenital
• Has a history of Guillain-Barré Syndrome

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 27, 2026
• Primary Completion (Estimated): August 8, 2028
• Study Completion (Estimated): August 8, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share