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

COMPLETEDPHASE3

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

A Phase 3, Open-Label, Randomized Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and an Intramuscular Recombinant 9-Valent Human Papillomavirus (9vHPV) Vaccine in Subjects Aged ≥9 to <15 Years in an Endemic Country for Dengue

NCT04313244•Takeda

View on ClinicalTrials.gov

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.

Detailed Description

The vaccine being tested in this study is called Tetravalent Dengue Vaccine (TDV). The study will assess the immunogenicity and safety on the co-administration of 9vHPV vaccine with TDV in healthy participants aged ≥9 to \<15 years. The study will enroll approximately 614 healthy volunteers. Participants will be randomly assigned to one of the two treatment groups- * Group 1 * Group 2 All participants will receive recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) intramuscular (IM) in combination with Dengue Tetravalent Vaccine (TDV) subcutaneous (SC) injection on Day 1 (Month 0 ) followed by 9vHPV on Day 90 (Month 3) and TDV on Day 180 (Month 6) in Group 1. Participants will receive 9vHPV on Day 1 (Month 0) and Day 180 (Month 6) IM in Group 2. This multi-center trial will be conducted in Thailand. The overall time to participate in this study is 12 months. Participants will make multiple visits to the clinic, after last dose of study drug for a follow-up assessment.

Eligibility

Age

9 - 14 years

Sex

ALL

Healthy Volunteers

Yes

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.
+11 more criteria

Locations (4)

Siriraj Hospital

Bangkoknoi, Khet Bangkok Noi, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

The Hospital for Tropical Diseases

Bangkok, Thailand

Thammasat University Hospital

Pathum Thani, Thailand

Key Dates

Start Date

May 15, 2021

Primary Completion Date

February 21, 2022

Completion Date

July 19, 2022

Last Updated

February 7, 2024

Enrollment

614

ACTUAL participants

Conditions

Dengue Fever

Interventions

9vHPV Vaccine

BIOLOGICAL

Dengue Tetravalent Vaccine (TDV)

BIOLOGICAL

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

NCT07007585

DengueDengue Fever+1 more

View study

RECRUITINGPHASE3

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers

NCT06665035

Dengue Fever

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection

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