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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1222-2812 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.
The vaccine being tested in this study is tetravalent dengue vaccine (TDV). The primary objective of this study is to evaluate the immune response and safety of a naturally aged (>12 months stored at 2°C to 8°C) lot of TDV in a healthy adult population in country(ies) non-endemic for dengue. The assessment of a naturally aged lot of TDV in this clinical trial will provide an important contribution to data on TDV stability throughout the shelf life of the product.
The study will enroll approximately 200 participants. Participants will be enrolled to the one treatment group:
Tetravalent Dengue Vaccine (TDV)
All participants will receive subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3).
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 9 months. Participants will make multiple visits to the clinic including a final visit at Day 270 (Month 9).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetravalent Dengue Vaccine (TDV) | Experimental | TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetravalent Dengue Vaccine (TDV) | Biological | TDV SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 | GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4. | One month post second dose (Day 120) |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. |
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Inclusion Criteria:
Exclusion Criteria:
Participants with a clinically significant active infection (as assessed by the investigator) or body temperature ≥38°C (≥100.4°F) within 3 days of the intended date of vaccine administration
Known or suspected impairment/alteration of immune function, including:
With Body Mass Index (BMI) greater than or equal to 35 kg/m^2(=weight in kg/height in meters^2).
Participants who have known hypersensitivity or allergy to any of the vaccine components.
Previous and planned vaccination (during the trial conduct), against any flavivirus 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 (e.g., West Nile [WN] virus) candidate vaccine, except for participants who received placebo in those trials.
With a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
Participants with history of substance or alcohol abuse within the past 2 years.
Participants who have any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92805 | United States | ||
| Hutchinson Clinic |
| 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. | |
| 37846724 | Derived | Patel SS, Winkle P, Faccin A, Nordio F, LeFevre I, Tsoukas CG. An open-label, Phase 3 trial of TAK-003, a live attenuated dengue tetravalent vaccine, in healthy US adults: immunogenicity and safety when administered during the second half of a 24-month shelf-life. Hum Vaccin Immunother. 2023 Aug;19(2):2254964. doi: 10.1080/21645515.2023.2254964. Epub 2023 Oct 17. |
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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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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 were enrolled in this study to receive Tetravalent Dengue Vaccine (TDV) on Days 1 and 90.
Participants took part in the study at 2 investigative sites in the United States from 28 March 2019 to 13 March 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetravalent Dengue Vaccine (TDV) | TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (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 TDV trial vaccine.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetravalent Dengue Vaccine (TDV) | TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (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 (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 | GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4. | Per-protocol Set (PPS) excludes all participants seropositive for dengue virus at Baseline and includes all participants in the Full Analysis Set (FAS- who received at least 1 dose of trial vaccine with valid pre-dose and post-dose measurement for immunogenicity assessment) who have no major protocol violations, with data available for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month post second dose (Day 120) |
|
All-cause mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 270). Other (Non-serious) adverse events: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days).
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 | Tetravalent Dengue Vaccine (TDV) | TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study 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 | Jun 21, 2018 | May 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2019 | May 11, 2021 | 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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Not provided
| ID | Term |
|---|---|
| D053059 | Dengue Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| One month and six months post second dose (Days 120 and 270) |
| Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity for multiple dengue serotypes was summarized in the following categories: tetravalent and at least trivalent. | One month and six months post second dose (Days 120 and 270) |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 | GMTs of neutralizing antibodies were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50. | Six months post second dose (Day 270) |
| Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity | Solicited local adverse events (AEs) [at injection site] were collected by participants using diary cards within 7 days after each vaccination and included injection site 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)], injection site erythema [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)] and injection site swelling [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)]. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported. | Up to 7 days (Day of vaccination + 6 subsequent days) after each of the vaccination |
| Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity | Solicited systemic AEs were collected by participants using diary cards within 14 days after each 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°F). Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported. | Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination |
| Percentage of Participants With Any Unsolicited Adverse Events Following Each 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. | Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days) |
| Percentage of Participants With Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, leads to a congenital anomaly / birth defect in the offspring of a participant, or is an important medical event which may require intervention to prevent the items listed above or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | From first vaccination (Day 1) through end of study (Day 270) |
| Percentage of Participants With Medically Attended Adverse Events (MAAEs) | MAAEs are defined as AEs leading to an unscheduled 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) |
| Hutchinson |
| Kansas |
| 67502 |
| United States |
| 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 | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | BMI= weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. | The PPS excludes all participants seropositive for dengue virus at Baseline and includes all participants in the FAS who have no major protocol violations. Number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | One month and six months post second dose (Days 120 and 270) |
|
|
|
| Secondary | Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity for multiple dengue serotypes was summarized in the following categories: tetravalent and at least trivalent. | The PPS excludes all participants seropositive for dengue virus at Baseline and includes all participants in the FAS who have no major protocol violations. Number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | One month and six months post second dose (Days 120 and 270) |
|
|
|
| Secondary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 | GMTs of neutralizing antibodies were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50. | PPS excludes all participants seropositive for dengue virus at Baseline and includes all participants in the FAS who have no major protocol violations, with data available for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | Six months post second dose (Day 270) |
|
|
|
| Secondary | Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity | Solicited local adverse events (AEs) [at injection site] were collected by participants using diary cards within 7 days after each vaccination and included injection site 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)], injection site erythema [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)] and injection site swelling [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)]. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported. | Safety Set included all participants who received at least 1 dose of TDV trial vaccine. Number analyzed is the number of participants with data available for the specific category. | Posted | Number | percentage of participants | Up to 7 days (Day of vaccination + 6 subsequent days) after each of the vaccination |
|
|
|
| Secondary | Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity | Solicited systemic AEs were collected by participants using diary cards within 14 days after each 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°F). Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported. | Safety Set included all participants who received at least 1 dose of TDV trial vaccine. Number analyzed is the number of participants with data available for the specific category. | 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 Adverse Events Following Each 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. | Safety Set included all participants who received at least 1 dose of TDV trial vaccine. Number analyzed is the number of participants with data available for the specific category. | Posted | Number | percentage of participants | Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days) |
|
|
|
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, leads to a congenital anomaly / birth defect in the offspring of a participant, or is an important medical event which may require intervention to prevent the items listed above or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | Safety Set included all participants who received at least 1 dose of TDV trial vaccine. | Posted | Number | percentage of participants | From first vaccination (Day 1) through end of study (Day 270) |
|
|
|
| Secondary | Percentage of Participants With Medically Attended Adverse Events (MAAEs) | MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria. | Safety Set included all participants who received at least 1 dose of TDV trial vaccine. | Posted | Number | percentage of participants | From first vaccination (Day 1) through end of study (Day 270) |
|
|
|
| 0 |
| 200 |
| 5 |
| 200 |
| 0 |
| 200 |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | 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 |
|
| Day 120: DENV-3 |
|
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| Day 120: DENV-4 |
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| Day 270: DENV-1 |
|
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| Day 270: DENV-2 |
|
|
| Day 270: DENV-3 |
|
|
| Day 270: DENV-4 |
|
|
|
| Day 270: At Least Trivalent |
|
|
| Day 270: Tetravalent |
|
|
| Title | Measurements |
|---|---|
|
| DENV-4 |
|
|
| After First Vaccination, Pain: Mild |
|
|
| After First Vaccination, Pain: Moderate |
|
|
| After First Vaccination, Pain: Severe |
|
|
| After First Vaccination, Erythema: Any Severity |
|
|
| After First Vaccination, Erythema: Mild |
|
|
| After First Vaccination, Erythema: Moderate |
|
|
| After First Vaccination, Swelling: Any Severity |
|
|
| After First Vaccination, Swelling: Mild |
|
|
| After Second Vaccination, Any Solicited Local AEs |
|
|
| After Second Vaccination, Pain: Any Severity |
|
|
| After Second Vaccination, Pain: Mild |
|
|
| After Second Vaccination, Pain: Moderate |
|
|
| After Second Vaccination, Pain: Severe |
|
|
| After Second Vaccination, Erythema: Any Severity |
|
|
| After Second Vaccination, Erythema: Mild |
|
|
| After Second Vaccination, Swelling: Any Severity |
|
|
| After Second Vaccination, Swelling: Mild |
|
|
|
| After First Vaccination, Headache: Mild |
|
|
| After First Vaccination, Headache: Moderate |
|
|
| After First Vaccination, Headache: Severe |
|
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| After First Vaccination, Myalgia: Any Severity |
|
|
| After First Vaccination, Myalgia: Mild |
|
|
| After First Vaccination, Myalgia: Moderate |
|
|
| After First Vaccination, Myalgia: Severe |
|
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| After First Vaccination, Asthenia: Any Severity |
|
|
| After First Vaccination, Asthenia: Mild |
|
|
| After First Vaccination, Asthenia: Moderate |
|
|
| After First Vaccination, Asthenia: Severe |
|
|
| After First Vaccination, Malaise: Any Severity |
|
|
| After First Vaccination, Malaise: Mild |
|
|
| After First Vaccination, Malaise: Moderate |
|
|
| After First Vaccination, Malaise: Severe |
|
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| After First Vaccination, Fever: Any |
|
|
| After First Vaccination, Fever: 38.0-<38.5 |
|
|
| After First Vaccination, Fever: 38.5-<39.0 |
|
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| After Second Vaccination, Any Solicited Systemic Local AEs |
|
|
| After Second Vaccination, Headache: Any Severity |
|
|
| After Second Vaccination, Headache: Mild |
|
|
| After Second Vaccination, Headache: Moderate |
|
|
| After Second Vaccination, Headache: Severe |
|
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| After Second Vaccination, Myalgia: Any Severity |
|
|
| After Second Vaccination, Myalgia: Mild |
|
|
| After Second Vaccination, Myalgia: Moderate |
|
|
| After Second Vaccination, Myalgia: Severe |
|
|
| After Second Vaccination, Asthenia: Any Severity |
|
|
| After Second Vaccination, Asthenia: Mild |
|
|
| After Second Vaccination, Asthenia: Moderate |
|
|
| After Second Vaccination, Asthenia: Severe |
|
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| After Second Vaccination, Malaise: Any Severity |
|
|
| After Second Vaccination, Malaise: Mild |
|
|
| After Second Vaccination, Malaise: Moderate |
|
|
| After Second Vaccination, Malaise: Severe |
|
|
| After Second Vaccination, Fever: Any |
|
|
| After Second Vaccination, Fever: 38.0-<38.5 |
|
|
| After Second Vaccination, Fever: 38.5-<39.0 |
|
|
|