Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003339-24 | EudraCT Number |
Not provided
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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.
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-
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9vHPV Vaccine | Biological | 9vHPV intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkoknoi | Khet Bangkok Noi | 10700 | Thailand | ||
| King Chulalongkorn Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41058426 | Derived | 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. | |
| 40749348 |
| Label | URL |
|---|---|
| To obtain more information about this study, click this link. | View source |
Not provided
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.
Not provided
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.
Healthy participants aged ≥9 to <15 years in endemic areas for dengue were enrolled in this study to receive recombinant 9-valent human papillomavirus vaccine (9vHPV) alone or with tetravalent dengue vaccine (TDV).
Participants took part in the study at 4 investigative sites in Thailand from 15 May 2021 to 19 July 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 9vHPV+TDV | Participants received 0.5 mL 9vHPV intramuscularly (IM) and 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). |
| FG001 | 9vHPV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2021 | Jan 16, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dengue Tetravalent Vaccine (TDV) |
| Biological |
TDV subcutaneous injection |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | From first vaccination (Day 1 [Month 0]) through end of study (Day 360 [Month 12]) |
| Bangkok |
| 10330 |
| Thailand |
| The Hospital for Tropical Diseases | Bangkok | 10400 | Thailand |
| Thammasat University Hospital | Pathum Thani | 12121 | Thailand |
| 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. |
| 40099800 | 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. |
Participants received 0.5 mL 9vHPV IM once on Day 1 (Month 0) followed by 0.5 mL 9vHPV IM once on Day 180 (Month 6). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized Set included all randomized participants, regardless of whether any dose of the investigational products (IPs) was received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 9vHPV+TDV | Participants received 0.5 mL 9vHPV IM and 0.5 mL TDV 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). |
| BG001 | 9vHPV | Participants received 0.5 mL 9vHPV IM once on Day 1 (Month 0) followed by 0.5 mL 9vHPV IM once on Day 180 (Month 6). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Number of participants analyzed is the number of participants with data available for height at the Baseline. | Mean | Standard Deviation | centimeters (cm) |
| ||||||||||||||
| Weight | Number of participants analyzed is the number of participants with data available for weight at the Baseline. | Mean | Standard Deviation | kilograms (kg) |
| ||||||||||||||
| Body Mass Index (BMI) | BMI=weight (kg) / [height (m)]^2 | Number of participants analyzed is the number of participants with data available for BMI at the Baseline. | Mean | Standard Deviation | kilograms per meter square (kg/m^2) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Per-protocol Set (PPS) excluded all participants seropositive to any HPV type at Baseline and included all participants from the Full Analysis Set (FAS) who had no major protocol violations. Overall number of participants analyzed is the number of participants available for analyses. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 210 (Month 7) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PPS excluded all participants seropositive to any HPV type at Baseline and included all participants from the FAS who had no major protocol violations. Overall number of participants analyzed is the number of participants available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 210 (Month 7) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PPS excluded all participants seropositive to any HPV type at Baseline and included all participants from the FAS who had no major protocol violations. Overall number of participants analyzed is the number of participants available for analyses. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 120 (Month 4) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PPS excluded all participants seropositive to any HPV type at Baseline and included all participants from the FAS who had no major protocol violations. Overall number of participants analyzed is the number of participants available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 120 (Month 4) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PPS excluded all participants seropositive to any HPV type at Baseline and included all participants from the FAS who had no major protocol violations. Overall number of participants analyzed is the number of participants available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 120 (Month 4) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Set included all randomized participants who received at least 1 dose of IPs. | Posted | Number | percentage of participants | Up to 7 days (Day of vaccination + 6 subsequent days) after each vaccination |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Set included all randomized participants who received at least 1 dose of IPs. | Posted | Number | percentage of participants | Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Set included all randomized participants who received at least 1 dose of IPs. | Posted | Number | percentage of participants | Up to 28 days (Day of vaccination + 27 subsequent days) after each vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Set included all randomized participants who received at least 1 dose of IPs. | Posted | Number | percentage of participants | From first vaccination (Day 1 [Month 0]) through end of study (Day 360 [Month 12]) |
|
|
All-cause mortality and serious adverse events: From first vaccination (Day 1 [Month 0]) through end of study (Day 360 [Month 12]); Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) after each vaccination
Safety Set included all randomized participants who received at least 1 dose of IPs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 9vHPV+TDV | Participants received 0.5 mL 9vHPV IM and 0.5 mL TDV 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). | 0 | 307 | 31 | 307 | 253 | 307 |
| EG001 | 9vHPV | Participants received 0.5 mL 9vHPV IM once on Day 1 (Month 0) followed by 0.5 mL 9vHPV IM once on Day 180 (Month 6). | 0 | 307 | 22 | 307 | 223 | 307 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2020 | Jan 16, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D053059 | Dengue Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
|
|
|
|
|
|
|
| HPV-16 |
|
| HPV-18 |
|
| HPV-31 |
|
| HPV-33 |
|
| HPV-45 |
|
| HPV-52 |
|
| HPV-58 |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
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