Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects
Dengue Fever, Dengue Hemorrhagic Fever
About this trial
This is an interventional prevention trial for Dengue Fever focused on measuring Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Dengavaxia®
Eligibility Criteria
Inclusion Criteria:
- Participant aged 9 to 60 years (i.e., from the day of the 9th birthday to the day prior to the 61th birthday) on the day of inclusion.
- Participant in good health, based on medical history and physical examination.
- Informed consent form (ICF) or assent form was signed and dated by the participant (based on local regulations), and/or ICF was signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
- For participant aged 9 to 11 years: known (documented) receipt of at least 4 previous doses of diphtheria toxoid, tetanus toxoid and acellular pertussis-containing (DTaP) vaccines, with the last dose not within the last 5 years prior to enrolment.
OR For participant aged at least 12 years: known (documented or self-reported) receipt of at least 3 previous doses of diphtheria toxoid, tetanus toxoid, and whole cell pertussis-containing (DTwP) vaccines, with the last dose not within the last 5 years prior to enrolment.
- Participant (or participant and parent[s]/legally acceptable representatives) was able to attend all scheduled visits and complied with all trial procedures.
Exclusion Criteria:
- Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination).
- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
- Previous vaccination against dengue disease with the trial CYD dengue vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
- Known or suspected congenital or acquired immunodeficiency (including human immunodeficiency virus (HIV) infection with impaired immune function); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
- Thrombocytopenia, contraindicating IM vaccination.
- Bleeding disorder or receipt of anticoagulants within 3 weeks preceding inclusion, which might be a contraindication for IM vaccination, at the discretion of the Investigator.
- Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug addiction that, based on Investigator's judgment, may interfere with the participant's ability to comply with trial procedures.
- Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
- Identified as an Investigator or employee of the Investigator with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- Self-reported HIV, Hepatitis B, or Hepatitis C infection.
- Personal history of Guillain-Barré syndrome.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Concomitant Administration Group
Sequential Administration Group
Participants will be administered the first dose of CYD dengue vaccine concomitantly with a dose of Tdap vaccine.
Participants will be administered the first dose of CYD dengue vaccine 28 days after a dose of Tdap vaccine.