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

NCT04313244 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: DEN-3082022-003339-24
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Dengue Fever

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58

  GMTs for HPV were measured by immunoglobulin G binding assay (IgGBA) assay. HPV-6, HPV-11, HPV-16, HPV-18, HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58 were the types of HPV analyzed.

  Day 210 (Month 7)

Secondary Outcomes (8)

• Percentage of Participants With Seropositivity for HPV Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 as Measured by Immunoglobulin G Binding Assay (IgGBA)

  Day 210 (Month 7)

• GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes

  Day 120 (Month 4)

• Percentage of Participants With Seropositivity for Each of the 4 Dengue Serotypes

  Day 120 (Month 4)

• Percentage of Participants With Seropositivity for Multiple (2, 3 or 4) Dengue Serotypes

  Day 120 (Month 4)

• Percentage of Participants With Solicited Local Adverse Events for 7 Days Following Vaccination by Severity

  Up to 7 days (Day of vaccination + 6 subsequent days) after each vaccination

Study Arms (2)

9vHPV+TDV

EXPERIMENTAL

Participants will receive 0.5 mL 9vHPV intramuscularly (IM) with 0.5 mL TDV subcutaneously (SC) once on Day 1 (Month 0) followed by 0.5 mL TDV SC once on Day 90 (Month 3) and 0.5 mL 9vHPV IM once on Day 180 (Month 6).

Biological: 9vHPV Vaccine; Biological: Dengue Tetravalent Vaccine (TDV)

9vHPV

EXPERIMENTAL

Participants will receive 0.5 mL 9vHPV vaccine IM once on Day 1 (Month 0) followed by 0.5 mL 9vHPV vaccine IM once on Day 180 (Month 6).

Biological: 9vHPV Vaccine

Interventions

9vHPV Vaccine BIOLOGICAL

9vHPV intramuscular injection

9vHPV; 9vHPV+TDV

Dengue Tetravalent Vaccine (TDV) BIOLOGICAL

TDV subcutaneous injection

Also known as: TAK-003

9vHPV+TDV

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Participants who can comply with trial procedures and are available for the duration of follow-up.

You may not qualify if:

• Has an elevated oral temperature ≥38°C (≥100.4°F) within 3 days of the intended date of vaccination.
• Participants with contraindications, warnings and/or precautions to vaccination with Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) vaccine as specified within the prescribing information.
• Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease.
• 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.
• Abnormalities of splenic or thymic function.
• Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Siriraj Hospital

Bangkoknoi, Khet Bangkok Noi, 10700, Thailand

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

The Hospital for Tropical Diseases

Bangkok, 10400, Thailand

Location

Thammasat University Hospital

Pathum Thani, 12121, Thailand

Location

Related Publications (3)

• El Hindi T, Anugulruengkitt S, Lapphra K, Limkittikul K, Tangsathapornpong A, Galindo CM, Hellwig M, Roubinis N, Schuring R, Biswal S, Folschweiller N. Immunogenicity and safety of the live-attenuated tetravalent dengue vaccine (TAK-003) co-administered with recombinant 9-valent human papillomavirus vaccine. Vaccine. 2025 Oct 24;65:127786. doi: 10.1016/j.vaccine.2025.127786. Epub 2025 Oct 6.

  PMID: 41058426 DERIVED

• El Hindi T, Anugulruengkitt S, Lapphra K, Limkittikul K, Tangsathapornpong A, Galindo-Tsoukas C, Hellwig M, Roubinis N, Schuring R, Biswal S, Folschweiller N. Immunogenicity and safety of the live-attenuated tetravalent dengue vaccine (TAK-003) co-administered with recombinant 9-valent human papillomavirus vaccine. Vaccine. 2025 Aug 30;62:127558. doi: 10.1016/j.vaccine.2025.127558. Epub 2025 Jul 31.

  PMID: 40749348 DERIVED

• Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.

  PMID: 40099800 DERIVED

Related Links

• To obtain more information about this study, click this link.

MeSH Terms

Conditions

Dengue

Interventions

Dengue Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: May 15, 2021
• Primary Completion: February 21, 2022
• Study Completion: July 19, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

TH (4)