Prevention of dengue disease in toddlers, children, and adults in endemic areas, as well as travelers to endemic areas MedDRA version: 20.0 Level: LLT Classification code 10012309 Term: Dengue System Organ Class: 100000004862
Conditions
Interventions
Product Code: V181
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: NA
Other descriptive name: rDEN1delta30
Concentration unit: PFU/dose plaque forming unit(s)/dose
Co
Sponsors
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is healthy based on review of medical history and physical examination, according to the clinical judgement of the investigator. 2. Is male or female, from 18 years to 50 years of age inclusive, at the time of signing the informed consent. 3. Male participants are eligible to participate if they agree to the following for at least 90 days after administration of study intervention: • Abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR • Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: - Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP OR • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 2. * Has an acute febrile illness (temperature =38.0°C [=100.4°F] oral or equivalent) occurring within 72 hours before receipt of study vaccine/placebo. 3. Has a serious or progressive disease according to the investigator, including but not limited to cancer; uncontrolled diabetes; severe cardiac, renal, or hepatic insufficiency; or systemic autoimmune or neurologic disorder. 4. Has known or suspected impairment of immunological function, including but not limited to congenital or acquired immunodeficiency, HIV infection, hematologic malignancy, or treatment for autoimmune diseases. 5. Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access. 6. Has a known hypersensitivity to any component of the study vaccine/placebo, or history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention. 7. Has received a dose of any dengue vaccine (investigational or approved) before study entry, or plans to receive any dengue vaccine (investigational or approved) for the duration of the trial. 8. * Has received other licensed non-live vaccines within 14 days before receipt of study vaccine/placebo or is scheduled to receive any licensed non-live vaccine within 28 days following receipt of study vaccine/placebo. Exception: Inactivated influenza vaccine may be vaccine/placebo or at least 28 days after receipt of study vaccine/placebo. 9. * Has received a licensed live vaccine within 28 days before receipt of study vaccine/placebo or is scheduled to receive any live vaccine within 28 days after receipt of study vaccine/placebo. 10. Has received systemic corticosteroids (equivalent of =2 mg/kg/day of prednisone or =20 mg/d for persons weighing >10 kg) for =14 consecutive days and has not completed treatment at least 30 days before study entry or is expected to receive systemic corticosteroids at aforementioned dose and duration within 28 days after receipt of study vaccine/placebo. 11. Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. 12. Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, within 6 months before receipt of study vaccine/placebo or plans to receive immunosuppressive therapies within 28 days after receipt of study vaccine/placebo. 13. Has received a blood transfusion or blood products (including immunoglobulins) within 6 months before receipt of a study vaccine/placebo or plans to receive a blood transfusion or blood products (including immunoglobulins) within 28 days after receipt of study vaccine/placebo. 14. Has participated in another clinical study of an investigational product within 6 months before signing the informed consent, or plans to participate in another interventional clinical study at any time during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a casebycase basis for approval by the Sponsor. 15. Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes at Day 28 postvaccination for participants administered the V181 Low Potency Level versus V181 Mid Potency Level 2. To evaluate the safety and tolerability of 3 different V181 potency levels with respect to the proportion of participants experiencing serious adverse events (SAEs);Secondary Objective: 1. To evaluate the safety and tolerability of 3 different V181 potency levels with respect to the proportion of participants experiencing solicited adverse events (AEs);Primary end point(s): 1. Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) 2. Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) ;Timepoint(s) of evaluation of this end point: 1. Day 28 postvaccination 2. Up to 28 days postvaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) 2. Percentage of Participants With Solicited Systemic AEs ;Timepoint(s) of evaluation of this end point: 1. Up to 5 days postvaccination 2. Up to 28 days postvaccination | — |
Countries
Australia, Belgium, Canada, Finland, Germany, Israel, Korea, Republic of, Taiwan, United States
Contacts
Public ContactGCTO
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
Outcome results
None listed