Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years

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.