Dengue FeverPhase 3NCT04313244
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 study testing 9vHPV Vaccine and Dengue Tetravalent Vaccine (TDV) in people with Dengue Fever, run by Takeda at 4 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- What is being tested?
- 9vHPV Vaccine and Dengue Tetravalent Vaccine (TDV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 4 sitesThailand
- Study dates
- 15 May 2021to 19 Jul 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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.
- 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.
- 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.
- 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.
- Previous and planned vaccination (during the trial conduct) against HPV.
- Previous participation in any clinical trial of a dengue or other flavivirus (eg, West Nile [WN] virus) candidate vaccine, except for participants who received placebo in those trials.
- Has a current or previous infection with a flavivirus such as Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis.
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
The Hospital for Tropical Diseases
Bangkok, 10400
Siriraj Hospital
Bangkoknoi, Khet Bangkok Noi, 10700
Thammasat University Hospital
Pathum Thani, 12121
About this study
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
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.
Read the 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
- Being tested
- 9vHPV Vaccine, Dengue Tetravalent Vaccine (TDV)
- Keywords
- Drug therapy
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9vHPV VaccineBiological
9vHPV intramuscular injection
Dengue Tetravalent Vaccine (TDV)Biological
Also called TAK-003
TDV subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: 9vHPV Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Seropositive for HPV is defined as anti-HPV titers greater or equal to the prespecified cutoffs for any of the 9 HPV serotypes: HPV-6, HPV-11, HPV-16, HPV-18, HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58, measured by IgGBA. The serostatus cut-off is the antibody titer level above the assay's lower limit of quantification that reliably distinguishes sera samples classified by clinical likelihood of HPV infection and positive or negative status by previous versions of IgGBA or equivalent assay. The serostatus cut-offs for the 9 HPV serotypes: HPV-6= 9, HPV-11= 6, HPV-16= 5, HPV-18= 5, HPV-31= 3, HPV-33= 4, HPV-45= 3, HPV-52= 5 and HPV-58= 5. Percentages are rounded off to the nearest decimal point.
Measured: Day 210 (Month 7)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes
GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% (MNT50). The four dengue serotypes: DENV-1, DENV-2, DENV-3 and DENV-4. As prespecified in the protocol, the data for this outcome measure was collected and analyzed for participants in the 9vHPV+TDV arm group only.
Measured: Day 120 (Month 4)
Percentage of Participants With Seropositivity for Each of the 4 Dengue Serotypes
Seropositivity is defined as a reciprocal neutralizing antibody titer ≥10 for any of the 4 dengue serotypes. The four dengue serotypes: DENV-1, DENV-2, DENV-3 and DENV-4. As prespecified in the protocol, the data for this outcome measure was collected and analyzed for participants in the 9vHPV+TDV arm group only. Percentages are rounded off to the nearest decimal point.
Measured: Day 120 (Month 4)
Percentage of Participants With Seropositivity for Multiple (2, 3 or 4) Dengue Serotypes
Seropositivity is defined as a reciprocal neutralizing antibody titer ≥10 for any of the 4 dengue serotypes. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositive for multiple dengue serotypes were summarized for categories with at least one participant with event: trivalent (seropositive for 3 dengue serotypes), and tetravalent (seropositive for all 4 dengue serotypes). As prespecified in the protocol, the data for this outcome measure was collected and analyzed for participants in the 9vHPV+TDV arm group only. Percentages are rounded off to the nearest decimal point.
Measured: Day 120 (Month 4)
Percentage of Participants With Solicited Local Adverse Events for 7 Days Following Vaccination by Severity
Solicited local adverse events (AEs) (at injection site) were collected by participants using diary cards within 7 days after vaccination and included: Pain [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)]; erythema and swelling [Grade 0 (<25 millimeters [mm]), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)]. Percentages are rounded off to the nearest decimal point. The data for solicited local adverse events after any vaccination are presented. Only those categories with at least 1 participant with event are reported.
Measured: Up to 7 days (Day of vaccination + 6 subsequent days) after each vaccination
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 14 Days Following Vaccination by Severity
Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, asthenia, malaise, and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). Fever is defined as body temperature greater than or equal to 38°C (100.4 degrees Fahrenheit [°F]). Only categories with at least one participant with event following any vaccination are reported. Percentages are rounded off to the nearest decimal point. The data for solicited systemic adverse events after any vaccination are presented.
Measured: Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination
Percentage of Participants With Any Unsolicited AEs for 28 Days Following Vaccination
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration. Percentages are rounded off to the nearest decimal point. The data for unsolicited adverse events after any vaccination are presented.
Measured: Up to 28 days (Day of vaccination + 27 subsequent days) after each vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important which may require intervention to prevent the items listed above or may expose the participant to danger.
Measured: From first vaccination (Day 1 [Month 0]) through end of study (Day 360 [Month 12])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start15 May 2021
- Primary completion21 Feb 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313244
- Sponsor's protocol ID
- DEN-308
- Other IDs
- 2022-003339-24
- Status last verified
- Jan 2024
- First submitted
- 16 Mar 2020
- Last updated
- 7 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
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.
PubMed 41058426El 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.
PubMed 40749348Rauscher 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.
PubMed 40099800
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04313244
- Acronym / sponsor ID
- DEN-308
- Conditions
- Dengue Fever
- Keywords
- Drug therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Posted 7 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9vHPV+TDV | Experimental | Biological: 9vHPV Vaccine, Biological: Dengue Tetravalent Vaccine (TDV)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). |
| 9vHPV | Experimental | Biological: 9vHPV VaccineParticipants 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). |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
- Abnormalities of splenic or thymic function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9vHPV Vaccine9vHPV intramuscular injection | Biological | 9vHPV, 9vHPV+TDV |
| Dengue Tetravalent Vaccine (TDV)Also: TAK-003TDV subcutaneous injection | Biological | 9vHPV+TDV |
Primary outcome
Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58
Time frame: Day 210 (Month 7)
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.
8 secondary outcomes
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)
Time frame: Day 210 (Month 7)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes
Time frame: Day 120 (Month 4)
Percentage of Participants With Seropositivity for Each of the 4 Dengue Serotypes
Time frame: Day 120 (Month 4)
Percentage of Participants With Seropositivity for Multiple (2, 3 or 4) Dengue Serotypes
Time frame: Day 120 (Month 4)
Percentage of Participants With Solicited Local Adverse Events for 7 Days Following Vaccination by Severity
Time frame: Up to 7 days (Day of vaccination + 6 subsequent days) after each vaccination
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 14 Days Following Vaccination by Severity
Time frame: Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination
Percentage of Participants With Any Unsolicited AEs for 28 Days Following Vaccination
Time frame: Up to 28 days (Day of vaccination + 27 subsequent days) after each vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From first vaccination (Day 1 [Month 0]) through end of study (Day 360 [Month 12])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41058426El 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.
- Derived from this study: PubMed 40749348El 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.
- Derived from this study: PubMed 40099800Rauscher 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.
- To obtain more information about this study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 9vHPV Vaccine and Dengue Tetravalent Vaccine (TDV) in people with Dengue Fever, run by Takeda at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58 (time frame: Day 210 (Month 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313244, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.