Clinical Trials Logo
  1. Home
  2. Dengue Fever
  3. NCT04313244

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

Dengue Fever Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04313244
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date May 15, 2021
Completion date July 19, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04514107 - A Cluster-randomized Trial to EValuate the Efficacy of Wolbachia-InfecTed Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil (EVITA Dengue) Phase 2
Completed NCT00788151 - Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years Phase 2
Completed NCT02510638 - The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia N/A
Completed NCT01666652 - A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults Phase 1
Completed NCT01477671 - Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children N/A
Completed NCT01443247 - Role of Andi-d in Dengue Fever: a Pilot Study N/A
Completed NCT00831012 - Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31‐7164) in Healthy Adults Phase 1
Completed NCT00089908 - Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults Phase 1
Completed NCT01983553 - Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Completed NCT01134263 - Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia Phase 3
Completed NCT02741128 - Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults Phase 2
Completed NCT03620487 - Detection of Dengue Virus in Plasma of Patients in Nepal
Recruiting NCT02608047 - Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou N/A
Completed NCT02510690 - Factors Associated With Poor Dengue Outcomes in Malaysia N/A
Completed NCT01550016 - International Research Consortium on Dengue Risk Assessment, Management, and Surveillance N/A
Completed NCT01421732 - Laboratory Diagnosis and Prognosis of Severe Dengue N/A
Completed NCT00993447 - Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America Phase 2
Completed NCT01224639 - Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever Phase 1
Completed NCT01943825 - Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine Phase 2
Active, not recruiting NCT03465254 - Dengue Serostatus Study in the Philippines