Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2 |
Seropositive participants are defined as participants with quantifiable (tested positive at or above the limit of quantitation [LOQ]) serum neutralizing anti-Zika virus (ZIKV) antibodies. Data will be reported for the overall study population (regardless of pre-vaccination flavivirus (FV) serostatus) and in FV naïve participants only. |
Within 28 days after Dose 2 (Day 57) |
|
Primary |
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2 |
Seroconversion is defined as the percentage of participants with either pre-vaccination titer
| Within 28 days after Dose 2 (Day 57) |
|
Primary |
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus at 28 Days Post Dose 2 |
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for the overall study population (regardless of pre-vaccination FV serostatus) and in FV naïve participants only. |
Within 28 days after Dose 2 (Day 57) |
|
Primary |
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After First Dose of Vaccination |
Solicited local AEs (at injection site) included pain/tenderness (mild: mild discomfort to touch, moderate: discomfort with movement, severe: significant discomfort at rest, potentially life-threatening: emergency room [ER] visit or hospitalization), erythema/redness (mild: 2.5 - 5 cm, moderate: 5.1 - 10 cm, severe: > 10 cm, potentially life-threatening: necrosis or exfoliative dermatitis), and swelling/induration (mild: 2.5 - 5 cm and does not interfere with activity, moderate: 5.1 - 10 cm or interferes with activity, severe: > 10 cm or prevents daily activity, potentially life-threatening: Necrosis). Data will be reported for the overall study population and in FV naïve participants only. |
Within 7 days after Dose 1 (Up to Day 7) |
|
Primary |
Percentage of Participants With Solicited Local Injection Site Reactions for 7 Days After Second Dose of Vaccination |
Solicited local AEs (at injection site) included pain/tenderness (mild: mild discomfort to touch, moderate: discomfort with movement, severe: significant discomfort at rest, potentially life-threatening: ER visit or hospitalization), erythema/redness (mild: 2.5 - 5 cm, moderate: 5.1 - 10 cm, severe: > 10 cm, potentially life-threatening: necrosis or exfoliative dermatitis), and swelling/induration (mild: 2.5 - 5 cm and does not interfere with activity, moderate: 5.1 - 10 cm or interferes with activity, severe: > 10 cm or prevents daily activity, potentially life-threatening: Necrosis). Data will be reported for the overall study population and in FV naïve participants only. |
Within 7 days After Dose 2 (Days 29 to 35) |
|
Primary |
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After First Dose of Vaccination |
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs will be graded from 1(mild) to 4(potentially life threatening) by severity. Fever: Grade 1(mild)= 38.0-38.4 degrees Celsius(°C)/100.4-101.1 degrees Fahrenheit (°F), Grade 2(moderate)=38.5-38.9°C/101.2-102.0°F, Grade 3(severe)=39.0-40°C/102.1-104°F, Grade 4 (potentially life threatening)=>40°C/>104°F. Headache, fatigue, malaise, arthralgia, and myalgia: Grade 1=no interference with activity, Grade 2=some interference with activity(Headache: repeated use of non-narcotic pain reliever>24 hours or some interference with activity), Grade 3 =significant; prevents daily activity(Headache: significant; any use of narcotic pain reliever or prevents daily activity), and Grade 4=ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only. |
Within 7 days after Dose 1 (Up to Day 7) |
|
Primary |
Percentage of Participants With Solicited Systemic AEs for 7 Days After Second Dose of Vaccination |
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs will be graded from 1(mild) to 4(potentially life threatening) by severity. Fever: Grade 1(mild)= 38.0-38.4°C/100.4-101.1°F, Grade 2(moderate)=38.5-38.9°C/101.2-102.0°F, Grade 3(severe)=39.0-40°C/102.1-104°F, Grade 4 (potentially life threatening)=>40°C/>104°F. Headache, fatigue, malaise, arthralgia, and myalgia: Grade 1=no interference with activity, Grade 2=some interference with activity(Headache: repeated use of non-narcotic pain reliever>24 hours or some interference with activity), Grade 3 =significant; prevents daily activity(Headache: significant; any use of narcotic pain reliever or prevents daily activity), and Grade 4=ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only. |
Within 7 days After Dose 2 (Days 29 to 35) |
|
Primary |
Percentage of Participants With at Least One Unsolicited AE for 28 Days After First Dose of Vaccination |
An unsolicited AE is any AE reported by the participant that is either not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting solicited AE (ie, 7 days in total including the day of PIZV or placebo administration). Unsolicited AEs will be graded from 1 to 4 by severity, where Grade 1 (mild)= no interference with activity, Grade 2 (moderate)= some interference with activity, Grade 3 (severe)= significant; prevents daily activity, and Grade 4 (potentially life threatening)= ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only. |
Within 28 days after dose 1 (Up to Day 29) |
|
Primary |
Percentage of Participants With at Least One Unsolicited AE for 28 Days After Second Dose of Vaccination |
An unsolicited AE is any AE reported by the participant that is either not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting solicited AE (ie, 7 days in total including the day of PIZV or placebo administration). Unsolicited AEs will be graded from 1 to 4 by severity, where Grade 1 (mild)= no interference with activity, Grade 2 (moderate)= some interference with activity, Grade 3 (severe)= significant; prevents daily activity, and Grade 4 (potentially life threatening)= ER visit or hospitalization. Data will be reported for the overall study population and in FV naïve participants only. |
Within 28 days after dose 2 (Days 29 to 57) |
|
Primary |
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Entire Study Period |
An SAE will be 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 important medical 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. Data will be reported for the overall study population and in FV naïve participants only. |
From day of first vaccination (Day 1) up to end of the study (Day 211) |
|
Primary |
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) Throughout the Entire Study Period |
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an PIZV or placebo; it does not necessarily have to have a causal relationship with PIZV or placebo administration. AESI is defined as an AE collected through the study period and entered in the eCRF by the investigator or designee within 24 hours of becoming aware of the event which includes new onset of or worsening of the following neurologic diseases: Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions, and anaphylaxis. Data will be reported for the overall study population and in FV naïve participants only. |
From day of first vaccination (Day 1) up to end of the study (Day 211) |
|
Primary |
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) Throughout the Entire Study Period |
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is 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. Data will be reported for the overall study population and in FV naïve participants only. |
From day of first vaccination (Day 1) up to end of the study (Day 211) |
|
Secondary |
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus |
Seropositive participants are defined as participants with quantifiable (tested positive at or above the LOQ) serum neutralizing anti-ZIKV antibodies. Data will be reported for the overall study population and in FV naïve participants only. |
Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211) |
|
Secondary |
Percentage of Participants With Seropositivity for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants |
Seropositive participants are defined as participants with quantifiable (tested positive at or above the LOQ) serum neutralizing anti-ZIKV antibodies. Data will be reported for FV exposed participants only. |
Baseline (Day 1), within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211) |
|
Secondary |
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus |
Seroconversion is defined as the percentage of participants with either pre-vaccination titer
| Within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211) |
|
Secondary |
Percentage of Participants With Seroconversion for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants |
Seroconversion is defined as the percentage of participants with either pre-vaccination titer
| Within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211) |
|
Secondary |
Geometric Mean Titers (GMTs) for Neutralizing Antibodies Against Zika Virus |
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for the overall study population and in FV naïve participants only. |
Baseline (Day 1), within 28 days after Dose 1 (Day 29) and 6 months after Dose 2 (Day 211) |
|
Secondary |
GMTs for Neutralizing Antibodies Against Zika Virus in FV Exposed Participants |
GMTs for neutralizing antibodies against ZIKV will be measured by assessing the quantity of neutralizing antibodies that bind ZIKV. Data will be reported for FV exposed participants only. |
Baseline (Day 1), within 28 days after Dose 1 (Day 29), 28 days after Dose 2 (Day 57) and 6 months after Dose 2 (Day 211) |
|
Secondary |
Percentage of Participants With at Least One Serious Adverse Event (SAE) From 28 Days up to 6 Months Post Dose 2 |
An SAE will be 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 important medical 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. Data will be reported for the overall study population and in FV naïve participants only. |
From 28 days up to 6 months post Dose 2 (Up to Day 211) |
|
Secondary |
Percentage of Participants With at Least One SAE in FV Exposed Participants |
An SAE will be 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 important medical 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. Data will be reported for FV exposed participants only. |
Within 28 days post Dose 1 (Day 29), 28 days post Dose 2 (Day 57) and 6 months post Dose 2 (Up to Day 211) |
|
Secondary |
Percentage of Participants With at Least One Adverse Events of Special Interest (AESI) From 28 Days up to 6 Months Post Dose 2 |
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. An AE will be considered AESI if any participant experiences a new onset of or worsening of the following neurologic diseases: GBS, acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions and/or anaphylaxis. Data will be reported for the overall study population and in FV naïve participants only. |
From 28 days up to 6 months post Dose 2 (Up to Day 211) |
|
Secondary |
Percentage of Participants With at Least One AESI in FV Exposed Participants |
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. An AE will be considered AESI if any participant experiences a new onset of or worsening of the following neurologic diseases: GBS, acute disseminated encephalomyelitis, idiopathic peripheral facial nerve palsy (Bell's palsy), seizures including but not limited to febrile seizures and/or generalized seizures/convulsions and/or anaphylaxis. Data will be reported for FV exposed participants only. |
Within 28 days post Dose 1 (Day 29), 28 days post Dose 2 (Day 57) and 6 months post Dose 2 (Up to Day 211) |
|
Secondary |
Percentage of Participants With at Least One Medically-Attended Adverse Event (MAAE) From 28 Days up to 6 Months Post Dose 2 |
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is 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. Data will be reported for the overall study population and in FV naïve participants only. |
From 28 days up to 6 months post Dose 2 (Up to Day 211) |
|
Secondary |
Percentage of Participants With at Least One MAAE in FV Exposed Participants |
AE: any untoward medical occurrence in a clinical investigation participant administered PIZV or placebo; it does not necessarily have to have a causal relationship with trial vaccine administration. MAAEs is 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. Data will be reported for FV exposed participants only. |
Within 28 days post Dose 1 (Day 29), 28 days post Dose 2 (Day 57) and 6 months post Dose 2 (Up to Day 211) |
|