Lower Respiratory Tract InfectionPhase 1NCT07855510
A Clinical Trial of V175 and V175A in Healthy Adults
A Phase 1 study testing V175 and V175A in people with Lower Respiratory Tract Infection, run by Merck Sharp & Dohme LLC at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Respiratory Tract Infection
- What is being tested?
- V175 and V175A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 564 participants
- Where
- 2 sitesAustralia
- Study dates
- 21 Oct 2026to 8 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- 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
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Nucleus Network ( Site 0002)
Brisbane, Queensland, 4006
Study Coordinator, 610737072720
- Recruiting
Nucleus Network ( Site 0001)
Melbourne, Victoria, 3004
Study Coordinator, 610385939801
About this study
Official title: A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V175 and V175A in Healthy Adults
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
- Being tested
- V175, V175A, Control Vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V175Biological
Intramuscular administration
V175ABiological
Intramuscular administration
Control VaccineBiological
Intramuscular administration
PlaceboOther
Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| V175 | Experimental | Participants will receive a single intramuscular (IM) vaccination of V175 on Day 1. Receives: Biological: V175 |
| V175A | Experimental | Participants will receive a single IM vaccination of V175A on Day 1. Receives: Biological: V175A |
| Control Vaccine | Active comparator | Participants will receive a single IM vaccination of control vaccine on Day 1. Receives: Biological: Control Vaccine |
| Placebo | Placebo comparator | Participants will receive a single IM vaccination of placebo on Day 1. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Immediate Reactions After Vaccination
The percentage of participants with immediate reactions after vaccination will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Titers of Anti-RSV-A Neutralizing Antibody will be measured via the virus reduction neutralization test. GMR of Anti-Respiratory Syncytial Virus-A (RSV-A) Neutralizing Antibodies Elicited by V175/V175A relative to control vaccine will be reported.
Measured: Up to approximately 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start21 Oct 2026
- Primary completion8 Aug 2028 (estimated)
- Study completion8 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855510
- Sponsor's protocol ID
- V175-001
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V175 and V175A in Healthy Adults
- ClinicalTrials.gov ID
- NCT07855510
- Acronym / sponsor ID
- V175-001
- Conditions
- Lower Respiratory Tract Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- 8 Aug 2028 (estimated)
- Study completion
- 8 Aug 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| V175 | Experimental | Biological: V175Participants will receive a single intramuscular (IM) vaccination of V175 on Day 1. |
| V175A | Experimental | Biological: V175AParticipants will receive a single IM vaccination of V175A on Day 1. |
| Control Vaccine | Active comparator | Biological: Control VaccineParticipants will receive a single IM vaccination of control vaccine on Day 1. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single IM vaccination of placebo on Day 1. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V175Intramuscular administration | Biological | V175 |
| V175AIntramuscular administration | Biological | V175A |
| Control VaccineIntramuscular administration | Biological | Control Vaccine |
| PlaceboIntramuscular administration | Other | Placebo |
Primary outcome
Percentage of Participants With Immediate Reactions After Vaccination
Time frame: Up to approximately 30 minutes after vaccination
The percentage of participants with immediate reactions after vaccination will be reported.
Percentage of Participants With a Solicited Injection-Site Adverse Event
Time frame: Up to approximately 7 days after vaccination
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.
Percentage of Participants With a Solicited Systemic Adverse Event
Time frame: Up to approximately 7 days after vaccination
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.
Percentage of Participants With an Unsolicited Adverse Event
Time frame: Up to approximately 28 days after vaccination
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.
Percentage of Participants With a Serious Adverse Event (SAE)
Time frame: Up to approximately 12 months after vaccination
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.
Percentage of Participants With a Medically Attended Adverse Event (MAAE)
Time frame: Up to approximately 12 months after vaccination
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.
Percentage of Participants With an Adverse Event of Special Interest (AESI) Including Potential Immune-Mediated Diseases (pIMDs)
Time frame: Up to approximately 12 months after vaccination
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.
1 secondary outcome
Geometric Mean Ratio (GMR) of Anti-Respiratory Syncytial Virus-A (RSV-A) Neutralizing Antibodies Elicited by V175/V175A Relative to Control Vaccine
Time frame: Up to approximately 28 days after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V175 and V175A in people with Lower Respiratory Tract Infection, run by Merck Sharp & Dohme LLC at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Immediate Reactions After Vaccination (time frame: Up to approximately 30 minutes after vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.