Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years
Condition: Dengue Fever
MeSH terms: Dengue
Intervention: 9vHPV Vaccine; Dengue Tetravalent Vaccine (TDV)
Intervention description: 9vHPV intramuscular injection; TDV subcutaneous injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 614.0
Sex: All
Minimum age: 9 Years
Maximum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to
      2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine
      administered alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Participants who can comply with trial procedures and are available for the duration
             of follow-up.

        Exclusion Criteria:

          1. Has an elevated oral temperature ≥38°C (≥100.4°F) within 3 days of the intended date
             of vaccination.

          2. Participants with contraindications, warnings and/or precautions to vaccination with
             Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) vaccine as specified within
             the prescribing information.

          3. Has any history of progressive or severe neurologic disorder, seizure disorder or
             neuro-inflammatory disease.

          4. 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 B virus infection.

               8. Hepatitis C virus infection.

               9. Genetic immunodeficiency.

          5. Abnormalities of splenic or thymic function.

          6. Has a known bleeding diathesis, or any condition that may be associated with a
             prolonged bleeding time.

          7. Who received any other vaccines 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.

          8. Who have used antipyretics and/or analgesic medications within 24 hours prior to
             vaccination. The reason for their use (prophylaxis versus treatment) must be
             documented. Trial entry should be delayed to allow for a full 24 hours to have passed
             since last use of antipyretics and/or analgesic medications.

          9. Previous and planned vaccination (during the trial conduct), against any flavivirus
             (except Japanese encephalitis [JE]) including dengue, yellow fever (YF) viruses or
             tick-borne encephalitis.

         10. Previous and planned vaccination (during the trial conduct) against HPV.

         11. 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.

         12. Has a current or previous infection with a flavivirus such as Zika, YF, JE, WN fever,
             tick-borne encephalitis or Murray Valley encephalitis.