Safety and Antibody Response of Three V181 Dengue Vaccine Strengths in Adults
- Conditions
- Prevention of dengue disease in toddlers, children, and adults in endemic areas, as well as travelers to endemic areasMedDRA version: 20.0Level: LLTClassification code 10012309Term: DengueSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-004501-30-DE
- Lead Sponsor
- Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1265
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 <1% per year), or be abstinent from heterosexual
intercourse as their preferred and usual lifestyle (abstinent on a long
term and persistent basis), for at least 90 days after administration of
study intervention. The investigator should evaluate the potential for
contraceptive method failure (ie, noncompliance, recently initiated) in
relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
5. The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide consent for Future Biomedical Research. However, the participant may participate in the main study without participating in Future Biomedical Research
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1265
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method