A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorMerck Sharp & Dohme LLC
About this trial
The purpose of this study is to demonstrate that V181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is generally healthy based on medical history and physical examination.
Disqualifiers
Has a known or suspected impairment of immunological function.
Has a history of congenital or acquired immunodeficiency.
Has a documented human immunodeficiency virus (HIV) infection or is breastfeeding from a mother with documented HIV infection.
Has a documented history of hepatitis B or C infection.
Trial design
Design model
Parallel
Treatments tested in this trial
V181
Biological/VaccineParticipants will receive a single 0.5 mL SC dose of V181 on Day 1.
Placebo
Biological/VaccineParticipants will receive a single 0.5 mL SC dose of placebo on Day 1.
Treatment groups
12,000 Participants
are divided into 2 treatment groupsGroup A: V181Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE)
A MAAE is an adverse event (AE) in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an ER visit, office visit, or an urgent care visit with any medical personnel for any reason.
Time frame
Up to approximately 6 months postvaccination2
Percentage of Participants Experiencing a Serious Adverse Event (SAE)
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Time frame
Up to approximately 5 years postvaccination3
Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited injection-site AEs will include pain/tenderness, erythema/redness, and swelling.
Time frame
Up to approximately 5 days postvaccination4
Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited systemic AEs will include rash, headache, tiredness (fatigue), muscle aches all over body (myalgia), joint pain and fever (pyrexia).
Time frame
Up to approximately 28 days postvaccinationSecondary outcomes
1
Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Each of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Time frame
Up to approximately 3 years postvaccination2
Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Time frame
Up to approximately 3 years postvaccination3
Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Time frame
Up to approximately 5 years postvaccination4
Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA.
Time frame
Up to approximately 5 years postvaccinationSponsors and contacts
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Source ClinicalTrials.gov