Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine
Condition: Healthy Volunteers
MeSH terms: Dengue; Hepatitis A
Intervention: TDV; HAV Vaccine; TDV Placebo; HAV Vaccine Placebo
Intervention description: TDV SC injection; HAV Vaccine IM injection.; Placebo-matching (normal saline (0.9% NaCl) SC injection.; Placebo-matching (normal saline (0.9% NaCl) IM injection.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 900.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine

Summary:

      The purpose of this study is to investigate the immunogenicity and safety of the concomitant
      administration of TDV (subcutaneous [SC] injection) and of hepatitis A virus (HAV) vaccine
      (intramuscular [IM] injection) in healthy participants aged 18 to 60 years living in
      country(ies) non-endemic for both dengue and hepatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant is aged 18 to 60 years, inclusive.

          2. Participants who are in good health at the time of entry into the trial as determined
             by medical history, physical examination (including vital signs) and the clinical
             judgment of the Investigator.

          3. The participant signs and dates a written informed consent form and any required
             privacy authorization prior to the initiation of any trial procedures, after the
             nature of the trial has been explained according to local regulatory requirements.

          4. Participants who can comply with trial procedures and are available for the duration
             of follow-up.

        Exclusion Criteria:

          1. Participants with an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the
             intended date of vaccination.

          2. Known hypersensitivity or allergy to any of the vaccine components (including
             excipients of the investigational vaccines or placebo).

          3. Participants with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the Investigator, may interfere with the participant's ability to
             participate in the trial.

          4. Participants with any history of progressive or severe neurologic disorder, seizure
             disorder orneuro-inflammatory disease (eg, Guillain-Barré syndrome).

          5. Participants with history or any illness that, in the opinion of the Investigator,
             might interfere with the results of the trial or pose additional risk to the
             participant due to participation in the trial.

          6. Known or suspected impairment/alteration of immune function, including:

               1. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2
                  mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month
                  0) (use of inhaled, intranasal, or topical corticosteroids is allowed).

               2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2
                  mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month
                  0).

               3. Administration of immunoglobulins and/or any blood products within the 3 months
                  prior to Day 1 (Month 0) or planned administration during the trial.

               4. Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).

               5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
                  within 6 months prior to Day 1 (Month 0).

               6. Human immunodeficiency virus (HIV) infection or HIV-related disease.

               7. Hepatitis A virus (HAV) infection.

               8. Hepatitis C virus infection.

               9. Genetic immunodeficiency.

          7. Abnormalities of splenic or thymic function.

          8. Participants with a known bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.

          9. Participants with any serious chronic or progressive disease according to judgment of
             the Investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic
             disease).

         10. Participants with body mass index (BMI) greater than or equal to 35 kg/m^2 (=weight in
             kg/[height in meters^2]).

         11. Participants participating in any clinical trial with another investigational product
             30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at
             any time during the conduct of this trial.

         12. Participants who received any other vaccine within 14 days (for inactivated vaccines)
             or 28 days (for live vaccines) prior to enrollment in this trial or who are planning
             to receive any vaccine within 28 days of trial vaccine administration.

         13. Previous HAV vaccination (in a clinical trial or with an approved product).

         14. Participants involved in the trial conduct or their first degree relatives.

         15. Participants with history of substance or alcohol abuse within the past 2 years.

         16. Female participants who are pregnant or breastfeeding.

         17. Females of childbearing potential who are sexually active, and who have not used any
             of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month
             0).

               1. Of childbearing potential is defined as status post onset of menarche and not
                  meeting any of the following conditions: bilateral tubal ligation (at least 1
                  year previously), bilateral oophorectomy (at least 1 year previously) or
                  hysterectomy

               2. Acceptable birth control methods are defined as one or more of the following:

             i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant,
             cervical ring).

             ii. Barrier method (condom with spermicide or diaphragm with spermicide) each and
             every time during intercourse.

             iii. Intrauterine device (IUD). iv. Monogamous relationship with vasectomized partner
             (partner must have been vasectomized for at least 6 months prior to Day 1 [Month 0]).

             Other contraceptive methods may be considered in agreement with the Sponsor and
             implemented only after approval of a substantial amendment by the regulatory
             authorities and by the appropriate ethics committee.

         18. Females of childbearing potential who are sexually active, and who refuse to use an
             acceptable contraceptive method up to 6 weeks after the last dose of trial vaccine
             (Day 90 [M3]). In addition, they must be advised not to donate ova during this period.

         19. Any positive or indeterminate pregnancy test.

         20. Previous and planned vaccination (during the trial conduct) against any flaviviruses
             including dengue, yellow fever (YF), Japanese Encephalitis (JE) viruses or tick-borne
             encephalitis.

         21. Previous participation in any clinical trial of a dengue or other flavivirus (eg, West
             Nile [WN] virus) candidate vaccine, except for participants who received placebo in
             those trials.

         22. Participants with a current or previous infection with a flavivirus such as dengue,
             Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis and
             participants with a history of prolonged (≥1 year) habitation in a dengue endemic
             area.

         23. Participants with contraindications, warnings and/or precautions to vaccination with
             the HAV vaccine as specified within the product information.