NCT04313244

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 614 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 9 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	9vHPV Vaccine	9vHPV intramuscular injection
BIOLOGICAL	Dengue Tetravalent Vaccine (TDV)	TDV subcutaneous injection

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-02-21
• Completion: 2022-07-19
• First posted: 2020-03-18
• Last updated: 2024-02-07
• Results posted: 2024-02-07

Locations

4 sites across 1 country: Thailand

Regulatory

• FDA-regulated drug study