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

Phase 1

• Conditions: Dengue fever; MedDRA version: 20.1Level: LLTClassification code 10012312Term: Dengue fever virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-003339-24-Outside-EU/EEA
• Lead Sponsor: Takeda Vaccines, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-21
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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.
3. The participant is aged =9 to <15 years.
Are the trial subjects under 18? yes
Number of subjects for this age range: 618
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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:
-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).
-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).
-Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
-Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
-Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
-Human immunodeficiency virus (HIV) infection or HIV-related disease.
-Hepatitis B virus infection.
-Hepatitis C virus infection.
-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 e [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.
13. Pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non-inferiority of the immune response (in terms of geometric mean titers [GMTs]) to 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine administered alone.<br>;Secondary Objective: • To describe the immune response to HPV (in terms of seroresponse) in subjects administered 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with subjects administered 2 doses of 9vHPV vaccine alone.<br>• To describe the immune response to TDV at 1 month following a second dose of TDV given 3 months after the first dose of TDV administered concomitantly with 9vHPV vaccine.<br>• To describe the safety profile after administration of TDV concomitantly with 9vHPV vaccine.;Primary end point(s): Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58;Timepoint(s) of evaluation of this end point: [Time Frame: Day 210 (Month 7)]