A Clinical Trial of V175 and V175A in Healthy Adults
ConditionLower Respiratory Tract Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-84
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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/m², inclusive
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
V175
Biological/VaccineIntramuscular administration
V175A
Biological/VaccineIntramuscular administration
Control Vaccine
Biological/VaccineIntramuscular administration
Placebo
Other interventionIntramuscular administration
Treatment groups
564 Participants
are divided into 4 treatment groupsGroup A: V175Experimental treatment 1 intervention
Group B: V175AExperimental treatment 1 intervention
Group C: Control VaccineActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With Immediate Reactions After Vaccination
The percentage of participants with immediate reactions after vaccination will be reported.
Time frame
Up to approximately 30 minutes after vaccination2
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.
Time frame
Up to approximately 7 days after vaccination3
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.
Time frame
Up to approximately 7 days after vaccination4
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.
Time frame
Up to approximately 28 days after vaccinationSecondary 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.
Time frame
Up to approximately 28 days after vaccinationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: