Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Intervention: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Placebo: NaCl 0.9%
Intervention description: 0.5 ml, Subcutaneous (SC); 0.5 ml, SC; 0.5 ml, SC; 0.5 ml, Subcutaneous (SC); 0.5 ml, SC
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: An observer-blind procedure was followed for the three injections with CYD dengue vaccine or placebo. Neither the observer, Investigator, Sponsor, nor the participant knew which product was administered.
Enrollment: 715.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine; Lot Consistency

Summary:

      The purpose of this study was to demonstrate that different CYD dengue vaccine lots
      manufactured using the same method and in the same location but at different times produce an
      equivalent immunological response after 3 doses.

      Primary Objective

        -  To demonstrate that three different Phase III lots of CYD dengue vaccine induce an
           equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against
           the four parental serotypes.

      Secondary Objectives:

        -  To demonstrate that data from one Phase II lot and pooled data from Phase III lots of
           CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs
           against the four parental serotypes.

        -  To describe the safety of the CYD dengue vaccine in all participants after each dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 to 60 years on the day of inclusion.

          -  Informed consent form was signed and dated.

          -  Able to attend all scheduled visits and to comply with all trial procedures.

          -  For a woman of childbearing potential, use of 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 (i.e., for 14 months).

        Exclusion Criteria:

          -  Known pregnancy, or a positive urine pregnancy test.

          -  History of flavivirus infection or vaccination or prolonged habitation in a dengue
             endemic area.

          -  Currently breastfeeding a child.

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the first trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except
             for pandemic influenza vaccination.

          -  Receipt of 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; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months).

          -  Self-reported seropositivity for human immunodeficiency virus (HIV).

          -  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.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction that might interfere with the ability to
             comply with trial procedures.

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion.

          -  Identified as a site employee of the Investigator or study center, with direct
             involvement in the proposed study or other studies under the direction of that
             Investigator or study center, as well as family members (i.e., immediate, husband,
             wife and their children, adopted or natural) of the site employees or the
             Investigator.