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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1192-7827 | Other Identifier | World Health Organization | |
| RNEC-2017-DEN-315 | Registry Identifier | Mexico | |
| 2018-003980-77 | EudraCT Number |
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The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.
The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for dengue.
The study enrolled 400 healthy participants. Participants were randomized in 3:1 ratio to receive:
In each trial group, participants received 2-dose schedule of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3), but not all participants received both doses (8 subjects discontinued the trial before receiving the second dose).
This multi-center trial was conducted in Mexico. The overall time to participate in this study was 270 days. Participants had multiple visits to the clinic including a final visit at Day 270.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetravalent Dengue Vaccine (TDV) | Experimental | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) |
|
| Placebo | Placebo Comparator | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetravalent Dengue Vaccine (TDV) | Biological | TDV subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 | GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10. | One month post second dose (Day 120) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 | GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10. | Six months post second dose (Day 270) |
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Inclusion Criteria:
Exclusion Criteria:
Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
Known hypersensitivity or allergy to any of the vaccine components.
Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial.
Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barre syndrome).
History or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participant due to participation in the trial.
Has known or suspected impairment/alteration of immune function, including:
Has abnormalities of splenic or thymic function.
Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding.
Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in square meters]).
Individuals participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intent to participate in another clinical trial at any time during the conduct of this trial.
Has received any other vaccine 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.
Individuals involved in the trial conduct or their first degree relatives.
Has history of substance or alcohol abuse within the past 2 years.
Female participants who are pregnant or breastfeeding.
Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (M0).
Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks after the last dose of trial vaccine. In addition, they must be advised not to donate ova during this period.
Any positive or indeterminate pregnancy test.
Previous and planned vaccination (during the trial conduct), against any flaviviruses including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
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.
Participants with documented or suspected disease caused by a flavivirus such as dengue, Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Pediatria (INP) | Mexico City | 04530 | Mexico | |||
| Hospital Infantil de Mexico Federico Gomez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 34131423 | Derived | Biswal S, Mendez Galvan JF, Macias Parra M, Galan-Herrera JF, Carrascal Rodriguez MB, Rodriguez Bueno EP, Brose M, Rauscher M, LeFevre I, Wallace D, Borkowski A. Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naive adolescents in Mexico City. Rev Panam Salud Publica. 2021 Jun 11;45:e67. doi: 10.26633/RPSP.2021.67. eCollection 2021. |
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Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Healthy volunteers were enrolled in a 3:1 ratio into 2 parallel study groups: 1 study group received 2 doses of Tetravalent Dengue vaccine (TDV) and another group received 2 doses of TDV matching placebo subcutaneously (SC).
Participants took part in the study at 5 investigative sites in Mexico from 14-Dec-2017 to 26-Jan-2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
| FG001 | Tetravalent Dengue Vaccine (TDV) | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set included all participants who received at least 1 dose of trial vaccine.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
| BG001 | Tetravalent Dengue Vaccine (TDV) | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 | GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10. | Per Protocol Set (PPS): all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month post second dose (Day 120) |
|
Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2019 | Jul 23, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2019 | Jul 23, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D053059 | Dengue Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo | Biological | Normal Saline (0.9% NaCl) subcutaneous injection |
|
| Seropositivity Rates for Each of the 4 Dengue Serotypes | Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | One month and six months post second dose (Day 120 and Day 270) |
| Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes | Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. | One month and six months post second dose (Day 120 and Day 270) |
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm) and swelling (edema/induration) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm). | Within 7 days after each vaccination |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity | Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia). Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. | Within 14 days after each vaccination |
| Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Within 28 days after each vaccination |
| Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study | MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. | From first vaccination (Day 1) through end of study (Day 270) |
| Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study | An SAE was 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 due to other reasons than the above mentioned criteria. | From first vaccination (Day 1) through end of study (Day 270) |
| Mexico City |
| 06720 |
| Mexico |
| Biodextra, S.A. de C.V. | Mexico City | 09360 | Mexico |
| Mexico Centre for Clinical Research | Mexico City | ZC 03100 | Mexico |
| Centro de Atencion E Investigacion Medica (CAIMED) Mexico DF | Mexico City | Mexico |
| Reason not Specified |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | BMI=Weight/Height. | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Tetravalent Dengue Vaccine (TDV) | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
|
|
| Secondary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 | GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10. | PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point. | Posted | Geometric Mean | 95% Confidence Interval | titer | Six months post second dose (Day 270) |
|
|
|
| Secondary | Seropositivity Rates for Each of the 4 Dengue Serotypes | Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | One month and six months post second dose (Day 120 and Day 270) |
|
|
|
| Secondary | Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes | Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. | PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | One month and six months post second dose (Day 120 and Day 270) |
|
|
|
| Secondary | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm) and swelling (edema/induration) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm). | Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported. | Posted | Number | percentage of participants | Within 7 days after each vaccination |
|
|
|
| Secondary | Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity | Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia). Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. | Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported. | Posted | Number | percentage of participants | Within 14 days after each vaccination |
|
|
|
| Secondary | Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported. | Posted | Number | percentage of participants | Within 28 days after each vaccination |
|
|
|
| Secondary | Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study | MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. | Safety Set included of all participants who received at least 1 dose of trial vaccine. | Posted | Number | percentage of participants | From first vaccination (Day 1) through end of study (Day 270) |
|
|
|
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study | An SAE was 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 due to other reasons than the above mentioned criteria. | Safety Set included of all participants who received at least 1 dose of trial vaccine. | Posted | Number | percentage of participants | From first vaccination (Day 1) through end of study (Day 270) |
|
|
|
| 0 |
| 100 |
| 2 |
| 100 |
| 38 |
| 100 |
| EG001 | Tetravalent Dengue Vaccine (TDV) | TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). | 0 | 300 | 1 | 300 | 112 | 300 |
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngitis bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 21.0 | 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.
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| DENV-2 |
|
|
| DENV-3 |
|
|
| DENV-4 |
|
|
| Day 120 (Month 4): DENV-2 |
|
|
| Day 120 (Month 4): DENV-3 |
|
|
| Day 120 (Month 4): DENV-4 |
|
|
| Day 270 (Month 9): DENV-1 |
|
|
| Day 270 (Month 9): DENV-2 |
|
|
| Day 270 (Month 9): DENV-3 |
|
|
| Day 270 (Month 9): DENV-4 |
|
|
| Day 120 (Month 4): At Least Trivalent |
|
|
| Day 120 (Month 4): Tetravalent |
|
|
| Day 270 (Month 9): At Least Bivalent |
|
|
| Day 270 (Month 9): At Least Trivalent |
|
|
| Day 270 (Month 9): Tetravalent |
|
|
| After First Vaccination, Pain:Mild |
|
|
| After First Vaccination, Pain:Moderate |
|
|
| After First Vaccination, Pain:Severe |
|
|
| After First Vaccination, Erythema:Mild |
|
|
| After First Vaccination, Swelling:Mild |
|
|
| After Second Vaccination, Any Solicited Local AEs |
|
|
| After Second Vaccination, Pain:Mild |
|
|
| After Second Vaccination, Pain:Moderate |
|
|
| After Second Vaccination, Pain:Severe |
|
|
| After Second Vaccination, Erythema:Mild |
|
|
| After Second Vaccination, Swelling:Mild |
|
|
| After Second Vaccination, Swelling:Moderate |
|
|
| After First Vaccination: Headache-Mild |
|
|
| After First Vaccination: Headache-Moderate |
|
|
| After First Vaccination: Headache-Severe |
|
|
| After First Vaccination: Asthenia-Mild |
|
|
| After First Vaccination: Asthenia-Moderate |
|
|
| After First Vaccination: Asthenia-Severe |
|
|
| After First Vaccination: Malaise-Mild |
|
|
| After First Vaccination: Malaise-Moderate |
|
|
| After First Vaccination: Malaise-Severe |
|
|
| After First Vaccination: Myalgia-Mild |
|
|
| After First Vaccination: Myalgia-Moderate |
|
|
| After First Vaccination: Myalgia-Severe |
|
|
| After First Vaccination:Fever-Any |
|
|
| After First Vaccination:Fever (38.0°C-<38.5°C) |
|
|
| After First Vaccination:Fever (38.5°C-<39.0°C) |
|
|
| After First Vaccination:Fever (39.0°C-<39.5°C) |
|
|
| After First Vaccination:Fever (39.5°C-<40.0°C) |
|
|
| After Second Vaccine: Any Solicited Systemic AEs |
|
|
| After Second Vaccination: Headache-Mild |
|
|
| After Second Vaccination: Headache-Moderate |
|
|
| After Second Vaccination: Headache-Severe |
|
|
| After Second Vaccination: Asthenia-Mild |
|
|
| After Second Vaccination: Asthenia-Moderate |
|
|
| After Second Vaccination: Asthenia-Severe |
|
|
| After Second Vaccination: Malaise-Mild |
|
|
| After Second Vaccination: Malaise-Moderate |
|
|
| After Second Vaccination: Malaise-Severe |
|
|
| After Second Vaccination: Myalgia-Mild |
|
|
| After Second Vaccination: Myalgia-Moderate |
|
|
| After Second Vaccination: Myalgia-Severe |
|
|
| After Second Vaccination:Fever-Any |
|
|
| After Second Vaccination:Fever (38.0°C-<38.5°C) |
|
|
| After Second Vaccination:Fever (38.5°C-<39.0°C) |
|
|
| After Second Vaccination:Fever (39.0°C-<39.5°C) |
|
|
| After Second Vaccination:Fever (39.5°C-<40.0°C) |
|
|
| After Second Vaccination |
|
|