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V181 Vaccine for Dengue Fever
Study Summary
This trial is testing a low and mid potency vaccine for Dengue virus. The primary hypothesis is that the low potency vaccine is non-inferior to the mid potency vaccine.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not taken immunosuppressive drugs recently.I have had dengue or zika in the past.I have not had a fever or flu-like symptoms in the last 3 days.I haven't taken high doses of steroids recently.I do not have uncontrolled diabetes, severe heart, kidney, or liver problems, autoimmune or neurological disorders.I have a condition that makes blood draws or injections risky.I have not received a blood transfusion or blood products recently.I have not received a dengue vaccine before and won't get one during the trial.I haven't had a live vaccine within 28 days before or after receiving the study vaccine.I am a male and will not have heterosexual intercourse or will use contraception for 90 days after treatment, unless I am sterile.I haven't had non-live vaccines 14 days before or plan to within 28 days after the study vaccine.I am not pregnant or breastfeeding and will follow the study's birth control requirements.
- Group 1: V181 Mid-Potency Level Group
- Group 2: V181 Low-Potency Level Group
- Group 3: V181 High-Potency Level Group
- Group 4: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any criteria that disqualify me from participating in this investigation?
"This clinical trial is targeting 1265 individuals between the ages of 18-50 that have been infected with dengue virus. Notably, males must either agree to abstain from heterosexual intercourse for 90 days or use contraception unless they are azoospermic. Females can only participate if not pregnant/breastfeeding and adhere to one of the following criteria: be non-childbearing potential (WOCBP); use highly effective contraception; or remain abstinent from sexual activity for 3 months post study intervention in accordance with local regulations."
Does administering V181 Low-Potency Level pose any risks to patient safety?
"With Phase 2 trials backing its safety record, V181 Low-Potency Level was assessed as a ‘2’ on our organization’s 1 to 3 scale. Though evidence of efficacy is lacking at this stage, the drug's security has been established."
Are there any vacancies left in this clinical investigation?
"Affirmative. Information furnished by clinicaltrials.gov confirms that the medical trial, which began on September 7th 2022, is actively seeking candidates. A total of 1265 participants need to be recruited from 10 different sites."
What is the participant size of this clinical trial?
"To complete this clinical trial, 1265 patients conforming to the eligibility requirements must partake. The research is conducted at multiple locations including Diex Recherche Quebec Inc. ( Site 0022) in Quebec and Diex Recherche Joliette (Site 0023) in Saint-Charles-Borromée, California."
Are there numerous locations in Canada conducting this research?
"Participants have the opportunity to join this trial at Diex Recherche Quebec Inc. ( Site 0022) in Quebec, Diex Recherche Joliette ( Site 0023) in Saint-Charles-Borromée, and Diex Recherche Victoriavile Inc. ( Site 0021) in Victoriaville as well as an additional 10 medical sites."
Is the patient pool for this trial limited to individuals aged 25 or younger?
"This research is open to individuals between 18 and 50 years of age."
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