A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)

Condition(s) studied

Investigational drug(s) / intervention(s)

V181: Participants will receive a single 0.5 mL SC dose of V181 on Day 1.

Placebo: Participants will receive a single 0.5 mL SC dose of placebo on Day 1.

Study summary

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

Primary outcome measure(s)

• Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE) — Up to approximately 6 months postvaccination
  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.
• Percentage of Participants Experiencing a Serious Adverse Event (SAE) — Up to approximately 5 years postvaccination
  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.
• Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs — Up to approximately 5 days postvaccination
  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.
• Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs — Up to approximately 28 days postvaccination
  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).
• Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Any of the 4 Dengue Serotypes, Regardless of 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 wild type (WT) reverse transcription polymerase chain reaction (RT-PCR) or non-structural protein 1 (NS1) enzyme-linked immunosorbent assay (ELISA).

Trial sites (41)

+ 1 more sites — see the full list on the official registry below.

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