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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1201-5778 | Registry Identifier | WHO |
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The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram [mcg]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post dose 2. In addition, the selected dose group and control group will be followed till 24 months post dose 2 for safety and persistence of immunity.
The vaccine being tested in this study is called PIZV or TAK-426 adjuvanted with aluminum hydroxide. The Zika virus vaccine is being tested to provide safety and immunogenicity data to enable the vaccine to be further developed clinically.
The study will enroll approximately 240 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four groups-which will remain undisclosed to the study observer:
All participants will be administered either placebo or PIZV by intramuscular (IM) injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4).
This multi-center trial will be conducted in the United States and Puerto Rico. The overall time to participate in this study is up to 25 months. Participants will make multiple visits to the clinic on Days 1, 8, 29, 36, 57, 211, 393 and will be contacted by telephone on Day 133 (Visit 7) and Day 575 (Visit 9) and also visit the clinic on Day 757 (Visit 11) depending on the study arm, for a final follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flavivirus-naïve Cohort: Placebo | Placebo Comparator | Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose). |
|
| Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | Experimental | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
| Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | Experimental | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
| Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | Experimental | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
| Flavivirus-primed Cohort: Placebo | Placebo Comparator | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
|
| Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo (normal saline (0.9% NaCl) IM injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first 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), erythema (<25 mm, mild: >=25 to- <=50 mm, moderate: >50 to <=100 mm, severe: >100 mm), and swelling and induration (<25 mm, mild: >=25 to <=-50 mm, moderate: >50 to <=100 mm, severe: >100 mm). Only categories for which there was at least 1 participant are reported. | Within 7 days after Dose 1 (Day 8) |
| Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first 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), erythema (<25 mm, mild: >=25 to <=50 mm, moderate: >50 to <=100 mm, severe: >100 mm), and swelling and induration (<25 mm, mild: >=25 to <=50 mm, moderate: >50 to <=100 mm, severe: >100 mm). Only categories for which there was at least 1 participant are reported. | Within 7 days after Dose 2 (Day 36) |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo | Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:>40°C. Only categories for which there was at least 1 participant are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced at Least One SAE During the Study | A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. |
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Inclusion Criteria:
Exclusion Criteria:
Participants and participants' partners with confirmed Zika virus (ZIKV) infection by self-report.
Traveling to flavivirus endemic countries or flavivirus endemic regions of the United States (US) or US territories*, within 4 weeks prior to screening or planned travel through to Visit 6 (applicable only to participants to be enrolled into the flavivirus naïve cohort).
a. Centers for Disease Control and Prevention (CDC) website define the information about the flavivirus endemic countries and US regions and territories.
Known hypersensitivity or allergy to any of the vaccine candidate components (including excipients of the investigational vaccine or placebo).
Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
Known or suspected impairment/alteration of immune function, including:
Has known current or chronic hepatitis B and/or hepatitis C infections.
Has abnormalities of spleen or thymic function.
Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Individuals participating in any clinical trial with another investigational product, including ZIKV vaccine clinical trial within 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
Individuals 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 investigational vaccine/placebo administration.
Female participants who are pregnant or breastfeeding, or are planning to become pregnant.
Any positive or indeterminate pregnancy test.
If female participant of childbearing potential, sexually active, and who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry:
"Of childbearing potential" is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years without any other alternative medical cause (as confirmed by a healthcare professional), status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
Acceptable birth control methods are defined as one or more of the following:
If female participant of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" from trial entry through 2 months after the last dose of investigational vaccine/placebo. In addition female participants of childbearing potential must be advised not to donate ova during this period.
To avoid sexual transmission of ZIKV from natural exposure: Refusal to use latex condoms correctly and consistently by sexually active participants even if other contraceptive measures are used from signing the informed consent form (ICF) through the end of the trial. Male participants must be advised not to donate sperm during this period.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States | ||
| Miami Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36484441 | Derived | Acosta CJ, Diaz C, Nordio F, Han HH, Moss KJ, Bohning K, Kumar P, Liu M, Patel H, Pacciarini F, Mwangi V, Walter E, Powell TD, El Sahly HM, Baldwin WR, Santangelo J, Anderson EJ, Dubin G. Persistence of Immunogenicity of a Purified Inactivated Zika Virus Vaccine Candidate in Healthy Adults: 2 Years of Follow-up Compared With Natural Infection. J Infect Dis. 2023 May 29;227(11):1303-1312. doi: 10.1093/infdis/jiac482. | |
| 34019802 |
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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.
Flavivirus (FV) status was determined using a Luminex assay targeting 13 FV. FV-naïve participants with median fluorescent intensity (MFI) below that assigned for negative cut-off were first enrolled in FV-naïve Cohort in ratio 1:1:1:1 to receive either placebo or purified inactivated Zika virus vaccine (PIZV). After positive recommendation from data monitoring committee, FV-primed participants, with MFI>500 were enrolled in FV-primed Cohort in ratio 1:1:1:1 to receive either placebo or PIZV.
Study participants, aged >=18 to <=49 years, were enrolled in this Phase 1 study in 9 sites in the United States and Puerto Rico from 13 November 2017 to 24 November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flavivirus-naïve Cohort: Placebo | Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose). |
| FG001 | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 12, 2018 | Nov 23, 2021 |
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| Experimental |
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
| Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | Experimental | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
| Flavivirus-primed Cohort: PIZV 10 mcg (High dose) | Experimental | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
| PIZV | Biological | Purified inactivated Zika virus vaccine with aluminum hydroxide adjuvant IM injection. |
|
|
| Within 7 days after Dose 1 (Day 8) |
| Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo | Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:>40°C. Only categories for which there was at least 1 participant are reported. | Within 7 days after Dose 2 (Day 36) |
| Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 1 of PIZV or Placebo | An AE was defined as any untoward medical occurrence in participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. | Within 28 days after Dose 1 (Day 29) |
| Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 2 of PIZV or Placebo | An AE was defined as any untoward medical occurrence in a clinical investigation participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. | Within 28 days after Dose 2 (Day 57) |
| Percentage of Participants Who Experienced at Least One Serious Adverse Event (SAE) Within 28 Days After Dose 1 of PIZV or Placebo | A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | Within 28 days after Dose 1 (Day 29) |
| Percentage of Participants Who Experienced at Least One SAE Within 28 Days After Dose 2 of PIZV or Placebo | A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | Within 28 days after Dose 2 (Day 57) |
| Geometric Mean Titers (GMTs) of Neutralizing Antibody for Zika Virus (ZIKV) 28 Days After Dose 2 of PIZV or Placebo | GMTs of neutralizing antibodies for ZIKV were measured by the Zika plaque reduction neutralization test (PRNT) test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation). | 28 days after Dose 2 (Day 57) |
| From day of first vaccination (Day 1) up to end of the study (Day 757) |
| GMTs of Neutralizing Antibody for ZIKV 28 Days After Dose 1 and 6 Months After Dose 2 | GMTs of neutralizing antibodies for ZIKV were measured by Zika PRNT test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation). | 28 days after Dose 1 (Day 29); 6 months after Dose 2 (Day 211) |
| GMTs of Neutralizing Antibody for ZIKV 12 Months and 24 Months After Dose 2 in Applicable Groups | GMTs of neutralizing antibodies for ZIKV were measured by Zika PRNT test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation). As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort. | 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757) |
| Percentage of Participants Seropositive for Neutralizing Antibodies Against PIZV 28 Days After Dose 1, 28 Days After Dose 2, and 6 Months After Dose 2 | Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. | 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57); 6 months after Dose 2 (Day 211) |
| Percentage of Participants Seropositive for PIZV 12 Months and 24 Months After Dose 2 in Applicable Groups | Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort. | 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757) |
| Percentage of Participants Seroconverted for PIZV 28 Days Post Dose 1 and 28 Days Post Dose 2 | Seroconverted participants were defined as participants at Baseline with detectable post-vaccination serum antibodies (test results are at or above LOD) and seropositive participants at Baseline with a four-fold increase in post-vaccination antibodies from Baseline, as measured by the neutralization assay. | 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57) |
| Miami |
| Florida |
| 33143 |
| United States |
| AppleMed Research | Miami | Florida | 33155 | United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| Regional Clinical Research Inc. | Endwell | New York | 13760 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Puerto Rico Clinical and Translational Research Consortium | San Juan | PR | 00936 | Puerto Rico |
| Ponce Medical School Foundation | Santurce | PR | 00909 | Puerto Rico |
| Derived |
| Han HH, Diaz C, Acosta CJ, Liu M, Borkowski A. Safety and immunogenicity of a purified inactivated Zika virus vaccine candidate in healthy adults: an observer-blind, randomised, phase 1 trial. Lancet Infect Dis. 2021 Sep;21(9):1282-1292. doi: 10.1016/S1473-3099(20)30733-7. Epub 2021 May 18. |
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
| FG002 | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| FG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| FG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| FG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| FG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| FG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| Safety Analysis Set | Safety Analysis Set included all participants who received at least one (1) dose of PIZV or placebo. |
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| Full Analysis Set | Full Analysis Set (FAS) included all randomized participants who had received at least one dose of the investigational vaccine/placebo and had provided valid Baseline and at least one post-vaccination serology result. |
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| Per Protocol Set | Per-Protocol Set (PPS) included participants in the FAS who had no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included all participants who received at least one (1) dose of PIZV or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Flavivirus-naïve Cohort: Placebo | Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose). |
| BG001 | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| BG002 | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| BG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| BG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| BG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| BG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| BG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | BMI is calculated as weight (kg) divided by square of height (m^2). | Mean | Standard Deviation | kg/m^2 |
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| 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 | |||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first 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), erythema (<25 mm, mild: >=25 to- <=50 mm, moderate: >50 to <=100 mm, severe: >100 mm), and swelling and induration (<25 mm, mild: >=25 to <=-50 mm, moderate: >50 to <=100 mm, severe: >100 mm). Only categories for which there was at least 1 participant are reported. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Overall number of participants are the number of participants with data available for analyses. | Posted | Number | percentage of participants | Within 7 days after Dose 1 (Day 8) |
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| Primary | Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first 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), erythema (<25 mm, mild: >=25 to <=50 mm, moderate: >50 to <=100 mm, severe: >100 mm), and swelling and induration (<25 mm, mild: >=25 to <=50 mm, moderate: >50 to <=100 mm, severe: >100 mm). Only categories for which there was at least 1 participant are reported. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Overall number of participants are the number of participants with data available for analyses. | Posted | Number | percentage of participants | Within 7 days after Dose 2 (Day 36) |
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| Primary | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo | Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:>40°C. Only categories for which there was at least 1 participant are reported. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Number analyzed is the number of participants with data available for analyses in the specific category. | Posted | Number | percentage of participants | Within 7 days after Dose 1 (Day 8) |
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| Primary | Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo | Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:>40°C. Only categories for which there was at least 1 participant are reported. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Number analyzed is the number of participants with data available for analyses in the specific category. | Posted | Number | percentage of participants | Within 7 days after Dose 2 (Day 36) |
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| Primary | Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 1 of PIZV or Placebo | An AE was defined as any untoward medical occurrence in participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. | Posted | Number | percentage of participants | Within 28 days after Dose 1 (Day 29) |
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| Primary | Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 2 of PIZV or Placebo | An AE was defined as any untoward medical occurrence in a clinical investigation participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. | Posted | Number | percentage of participants | Within 28 days after Dose 2 (Day 57) |
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| Primary | Percentage of Participants Who Experienced at Least One Serious Adverse Event (SAE) Within 28 Days After Dose 1 of PIZV or Placebo | A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. | Posted | Number | percentage of participants | Within 28 days after Dose 1 (Day 29) |
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| Primary | Percentage of Participants Who Experienced at Least One SAE Within 28 Days After Dose 2 of PIZV or Placebo | A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. | Posted | Number | percentage of participants | Within 28 days after Dose 2 (Day 57) |
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| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibody for Zika Virus (ZIKV) 28 Days After Dose 2 of PIZV or Placebo | GMTs of neutralizing antibodies for ZIKV were measured by the Zika plaque reduction neutralization test (PRNT) test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation). | Per-Protocol Set (PPS) included participants in the Full Analysis Set (FAS) who have no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Overall number of participants analyzed are the number of participants with data available for analyses. | Posted | Geometric Mean | 95% Confidence Interval | titer | 28 days after Dose 2 (Day 57) |
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| Secondary | Percentage of Participants Who Experienced at Least One SAE During the Study | A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. | Posted | Number | percentage of participants | From day of first vaccination (Day 1) up to end of the study (Day 757) |
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| Secondary | GMTs of Neutralizing Antibody for ZIKV 28 Days After Dose 1 and 6 Months After Dose 2 | GMTs of neutralizing antibodies for ZIKV were measured by Zika PRNT test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation). | PPS included participants in the FAS who have no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Number analyzed is the number of participants with data available for analysis at the given tlmepoint. | Posted | Geometric Mean | 95% Confidence Interval | titer | 28 days after Dose 1 (Day 29); 6 months after Dose 2 (Day 211) |
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| Secondary | GMTs of Neutralizing Antibody for ZIKV 12 Months and 24 Months After Dose 2 in Applicable Groups | GMTs of neutralizing antibodies for ZIKV were measured by Zika PRNT test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation). As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort. | PPS included participants in the FAS who had no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Geometric Mean | 95% Confidence Interval | titer | 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757) |
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| Secondary | Percentage of Participants Seropositive for Neutralizing Antibodies Against PIZV 28 Days After Dose 1, 28 Days After Dose 2, and 6 Months After Dose 2 | Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. | PPS included participants in the FAS who had no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57); 6 months after Dose 2 (Day 211) |
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| Secondary | Percentage of Participants Seropositive for PIZV 12 Months and 24 Months After Dose 2 in Applicable Groups | Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort. | PPS included participants in the FAS who had no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757) |
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| Secondary | Percentage of Participants Seroconverted for PIZV 28 Days Post Dose 1 and 28 Days Post Dose 2 | Seroconverted participants were defined as participants at Baseline with detectable post-vaccination serum antibodies (test results are at or above LOD) and seropositive participants at Baseline with a four-fold increase in post-vaccination antibodies from Baseline, as measured by the neutralization assay. | Per-Protocol Set (PPS) included participants in the Full Analysis Set (FAS) who have no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Number analyzed is the number of participants with data available for analysis at the given tlmepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57) |
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All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
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.
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 | Flavivirus-naïve Cohort: Placebo | Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose). | 0 | 31 | 1 | 31 | 4 | 31 |
| EG001 | Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). | 0 | 31 | 1 | 31 | 3 | 31 |
| EG002 | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). | 0 | 31 | 0 | 31 | 3 | 31 |
| EG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). | 0 | 32 | 2 | 32 | 4 | 32 |
| EG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). | 0 | 36 | 1 | 36 | 5 | 36 |
| EG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). | 0 | 37 | 2 | 37 | 5 | 37 |
| EG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). | 0 | 37 | 0 | 37 | 7 | 37 |
| EG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). | 0 | 36 | 4 | 36 | 8 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2019 | Nov 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| D018177 | Flavivirus Infections |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Puerto Rico |
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| Pain, Moderate |
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| Pain, Severe |
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| Erythema, <25 mm |
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| Induration, <25 mm |
|
| Swelling, <25 mm |
|
| Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) |
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
| OG002 | Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
| OG002 |
| Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose) |
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
| OG002 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
| Flavivirus-primed Cohort: Placebo |
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG003 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
|
|
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
| OG003 | Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG004 | Flavivirus-primed Cohort: Placebo | Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose). |
| OG005 | Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose) | PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG006 | Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose) | PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
| OG007 | Flavivirus-primed Cohort: PIZV 10 mcg (High Dose) | PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose). |
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