Phase I, Randomized, Double-blinded, Placebo-Controlled D... | NCT03008122

ID	Type	Description	Link
HHSN272201300021I

Description Module

Detailed Description

This study is a single-center, randomized, double-blinded, placebo-controlled, Phase 1, dose de-escalation study to evaluate the safety, reactogenicity, and immunogenicity of a purified inactivated, alum-adjuvanted ZIKV vaccine (ZPIV) administered in a homologous prime-boost regimen to healthy male and non-pregnant female adult subjects living in a flavivirus-endemic area. This study will enroll 90 subjects between the ages of 21 and 49 and will be conducted at Ponce Medical School Foundation, Inc.-CAIMED in Ponce, Puerto Rico. The entire duration of each subject's participation is approximately 26 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and collection of samples for the assessment of immunogenicity. This study is expected to take approximately 49 months to complete. Two dose levels will be evaluated. Each subject will receive either placebo or 5 mcg (Group 1) or 2.5 mcg (Group 2) of ZPIV administered by intramuscular (IM) injection on Days 1 and 29. The study will consist of a screening period of up to 28 days, a vaccination period in which subjects will receive a prime dose of vaccine on Day 1 followed by a homologous boost on Day 29, and a follow-up period of 24 months post boost vaccination. The study will begin with enrollment of 2 sentinel subjects in Group 1 who will receive 5 mcg ZPIV open label. One sentinel subject will be vaccinated, followed for one day for safety and reactogenicity, and if no halting rules are met per determination of the PI and co-PI, then the second sentinel subject will receive 5 mcg ZPIV open-label. Both sentinels will be followed for safety through Day 8 and if no predefined halting rules are met and no safety concerns are identified, then enrollment of the Group 1 non-sentinel subjects will proceed in double-blind fashion. The same procedure will be used for administration of the boost vaccination to the Group 1 sentinels: 1 sentinel (can be either) will receive 5 mcg ZPIV open-label, be followed for one day for safety and reactogenicity, and if no halting rules are met, then the 2nd sentinel will receive the boost vaccine. Both sentinels will be followed until Day 8 after 2nd vaccination for safety and reactogenicity and if no halting rules are met, then boost vaccination of the Group 1 non-sentinel subjects can proceed. Enrollment of the 2.5 mcg ZPIV group (Group 2) can begin after or at the same time non-sentinel subjects in Group 1 receive the 1st dose of vaccine. As of December 18, 2017, the majority of non-sentinel subjects in Group 1 have already received the 1st dose and have been followed until Day 8 for safety and reactogenicity, and no halting rules have been met or safety concerns identified. As this is a dose de-escalation study, concurrent enrollment of some remaining non-sentinel subjects in Groups 1 is permitted after enrollment of Group 2 subjects has begun; also, no sentinel subjects will be used in Group 2. All subjects in Group 2 will receive study product or placebo in double-blind fashion. The original study design planned to enroll 40 ZPIV recipients and 5 placebo recipients in each Group. However, due a natural disaster (hurricane Maria), 11 subjects enrolled in Group 1 had loss of samples at key timepoints. To rebalance the number of evaluable subjects between Groups, Group 1 enrollment will be increased by 5 subjects and Group 2 enrollment will be decreased by 5 subjects, for a total enrollment of 50 subjects in Group 1 and 40 in Group 2. Treatment assignments for both groups will be assigned according to the originally planned 8:1 ratio of ZPIV: placebo. Without compromising the blind of the study, we can anticipate approximately 35 evaluable ZPIV recipients and approximately 5 evaluable placebo recipients in each group. All subjects will receive a homologous boost of ZPIV or placebo 28 days post-prime if no halting rules precluding second vaccination are met (Section 9). All subjects will be monitored for occurrence of unsolicited AEs until 28 days after the second vaccination SAEs, AESIs, and history of new medical conditions with onset after the first vaccination will be collected for the duration of the study. Blood for evaluation of antibodies to ZIKV by ELISA and neutralizing antibody assays will be collected at Visit 00, prior to each vaccination, and at multiple timepoints afterward. Primary objectives are: 1) Assess the safety and reactogenicity of a homologous prime boost regimen of ZPIV given at two different dose levels in a dose de-escalation format in healthy adult subjects who live in Puerto Rico, a flavivirus endemic area. 2) Compare the safety and reactogenicity profile of ZPIV after each vaccination, between dosage groups, and by pre-vaccination flavivirus immune status. Secondary Objectives are: 1) Assess the humoral immune response to a homologous prime-boost regimen of ZPIV after each dose of vaccine as determined by kinetics of the immune responses, seroconversion rates, and Geometric Mean Titers (GMT) overall, and compare results between dosage groups and by pre-vaccination flavivirus immune status. 2) Assess the durability of the humoral immune response to ZPIV at 6, 12, 18, and 24 months after the second vaccine administration overall, and compare results between dosage groups and by pre-vaccination flavivirus immune status.

Label	Type	Description	Intervention Names
Group 1	Experimental	5 mcg ZPIV administered IM in a homologous prime-boost regimen on Day 1 and Day 29 , n=45 (2 sentinels, 43 non-sentinels) or placebo, n=5	Other: Placebo Biological: Zika Virus Purified Inactivated Vaccine (ZPIV)
Group 2	Experimental	2.5 mcg ZPIV administered IM in a homologous prime-boost regimen on Day 1 and Day 29, n=35 or placebo, n=5	Other: Placebo Biological: Zika Virus Purified Inactivated Vaccine (ZPIV)

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Placebo	Group 1 Group 2
Zika Virus Purified Inactivated Vaccine (ZPIV)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants	The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.	Day 1 through Day 8
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants	The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.	Day 29 through Day 36
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants	The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.	Day 1 through Day 8
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants	The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be a male or non-pregnant, non-breastfeeding female between the age of 21 and 49 years, inclusive at the time of screening and enrollment.
Must be willing and able to read, sign and date the informed consent document before study related procedures are performed.
Must be willing and able to comply with study requirements and available for follow-up visits for the entire study.
Must have a means to be contacted by telephone.
Must have a body mass index (BMI) > /= 18.1 and < 35.0 kg/m2.
Must have acceptable* screening laboratory findings within 28 days before enrollment.
- Acceptable clinical laboratory parameters include:
  - Hemoglobin: women: > /= 11.5 g/dL; men > /= 13.5 g/dL
  - Hemotocrit: women: > /= 34.5%; men > /= 40.5%
  - White blood cell count: > /= 3.500 cells/mm3 but < /= 10,800 cells/mm3
  - Platelets: > /= 150,000 but < /= 450,000 per mm3
  - Urine dipstick (clean urine sample): protein < 1+, glucose negative
  - Serum creatinine < /= 1 x institutional upper limit of normal (ULN)
  - Blood urea nitrogen (BUN) < 25
  - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.25 x institutional ULN
  - Total bilirubin < 1.25 x institutional ULN
- Note: If laboratory screening tests are out of acceptable range, repeat of screening tests is permitted once, provided there is an alternative explanation for the out of range value.
Must be in good health based on the investigator's clinical judgment when considering findings from past medical history, medication use, vital signs, and an abbreviated physical examination.

Note 1: Good health is defined by the absence of any medical condition described in the exclusion criteria in a subject with a normal abbreviated physical exam and vital signs. If the subject has a preexisting condition not listed in exclusion criteria, it cannot meet any of the following criteria: 1) first diagnosed in last 3 months; 2) worsening in terms of clinical outcome in last 6 months; or 3) involves need for medication that may pose a risk to subject's safety or impede assessment of adverse events or immunogenicity if they participate in study.

Note 2: An abbreviated physical exam differs from a complete exam in that it does not include a genitourinary and rectal exam.

Note 3: Vital signs must be normal by protocol toxicity grading scale or determined to be normal-variant by investigator. In the event of an abnormal heart rate or blood pressure due to physiological variation or activity, the subject may rest for 10 minutes in a quiet room, and then blood pressure and/or heart rate may be re-measured. Repeated vital signs may be used to determine eligibility.
Women of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test immediately prior to each vaccination.

Note: All female subjects are considered of childbearing potential unless postmenopausal or surgically sterilized and > /= 3 months have passed since sterilization procedure. Postmenopausal is defined as amenorrhea for > /= 12 months without an alternative medical cause. Permanent female sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, bilateral oophorectomy, or successful Essure placement.
Women of childbearing potential must use an acceptable method of contraception* from one month (30 days) prior to the first vaccination until the end of the study.

*Acceptable methods of contraception include the following:
- Use highly effective contraceptive methods, defined by < 1% failure rate per year independent of user adherence, including long-acting reversible contraception (LARC): progestin-releasing subdermal implants and intrauterine devices (IUD), OR
- Use effective contraceptive methods, defined by 5-9% failure rate with typical use and < 1% failure rate with consistent and correct use, including: prescription oral contraceptives, contraceptive injections, combined pill, progestin-only pill, hormone-releasing transdermal patch or vaginal ring, and depot medroxyprogesterone acetate injection (Depo-Provera), OR
- Male sex partners must have had a vasectomy > /= 3 months prior to first vaccination, OR
- Practice abstinence defined as refraining from heterosexual intercourse from 30 days before first vaccination until the end of the study.
Female subjects must agree to not donate eggs (ova, oocytes) from the start of screening period until the end of the study.
Subjects must provide concurrent consent at the time of enrollment and 1st vaccination to future use of stored blood samples to measure immunity to ZIKV.

Exclusion Criteria:

Has plans to become pregnant during the course of the study, or is currently pregnant or breastfeeding.
Plans to receive a licensed flavivirus vaccine or participate in another flavivirus vaccine trial during the study.
Has positive serology for HIV 1/2, Hepatitis C virus, or Hepatitis B surface antigen.
Has known or suspected congenital or acquired immunodeficiency, or recent history or current use of immunosuppressive therapy* *Anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Intranasal or topical prednisone (or equivalent) is allowed.
Had organ and/or stem cell transplantation whether or not on chronic immunosuppressive therapy.
Has history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure*.

*Subjects with a history of skin cancer must not be vaccinated at the previous tumor site.
Has history of chronic or acute severe neurologic condition*.

*Including history of Guillain-Barre syndrome, seizure disorder or epilepsy, Bell's palsy, meningitis, or disease with any focal neurologic deficits.
Has diabetes mellitus type 1 or type 2, including cases controlled with diet alone.

*Note: history of isolated gestational diabetes is not an exclusion criterion.
Has history of thyroidectomy, or thyroid disease requiring medication during the last 12 months.
Has major psychiatric illness during last 12 months that in the investigator's opinion would preclude participation.
Has history of other chronic disease or condition*.

*Includes the conditions and diagnoses defined as AESI in section 9, as well as autoimmune disease, hypercholesterolemia, chronic hepatitis or cirrhosis, chronic pulmonary disease, chronic renal disease, and chronic cardiac disease including hypertension even if medically controlled

- Vital signs must be normal by protocol toxicity grading scale or determined to be normal-variant by investigator. In the event of an abnormal heart rate or blood pressure due to physiological variation or activity, the subject may rest for 10 minutes in a quiet room, and then blood pressure and/or heart rate may be re-measured. Repeated vital signs may be used to determine eligibility.
Has current or past history of substance abuse that in the investigator's opinion would preclude participation.
Has tattoos, scars, or other marks on both deltoid areas that would, in the opinion of the investigator, interfere with assessment of the vaccination site.
Has a history of chronic urticaria (recurrent hives).
Has known allergy or history of anaphylaxis or other serious reaction to a vaccine or vaccine component*.

*Including aluminum hydroxide (alum) or aminoglycosides (e.g., neomycin and streptomycin).
Had major surgery (per the investigator's judgment) in the month prior to screening or plans to have major surgery during the study.
Received blood products or immunoglobulin in the 3 months prior to screening or planned use during the course of the study.
Donated a unit of blood within 8 weeks before Day 1 or plans to donate blood during the course of the study.
Received live attenuated vaccine from 30 days before Day 1 or plans to receive a live attenuated vaccine from Day 1 until 30 days after the last vaccination.
Received killed or inactivated vaccine from 14 days before Day 1 or plans to receive a killed or inactivated vaccine from Day 1 until 14 days after the last vaccination.
Received experimental therapeutic agents within 3 months prior to the first study vaccination or plans to receive any experimental therapeutic agents during the course of the study.
Is currently participating or plans to participate in another clinical study involving an investigational product, blood drawing, or an invasive procedure listed below.

*An invasive procedure requiring administration of anesthetics or intravenous dyes or removal of tissue would be excluded. This includes endoscopy, bronchoscopy, or administration of IV contrast.
Has an acute illness or temperature > /= 38.0ºC on Day 1 or Day 29* or within 2 days prior to vaccination.

*Subjects with fever or an acute illness on the day of vaccination or in the 2 days prior to vaccination may be re-assessed and enrolled if healthy or only minor residual symptoms remain within 2 days of Day 1 or Day 29.
Is a study site employee* or staff paid entirely or partially by the OCRR contract or subcontract for the trial, or staff who are supervised by the PI or Sub-Investigators.

*Including the Principal Investigator, sub-Investigators listed in Form FDA 1572 or Investigator of Record Form
In the investigator's opinion, the subject cannot communicate reliably, is unlikely to adhere to the study requirements, or has a condition that would limit their ability to complete the study.

Facility	Status	City	State	ZIP	Country	Contacts
Ponce School of Medicine CAIMED Center		Ponce		00716	Puerto Rico

ID	Title	Description
FG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 19, 2022	Dec 15, 2022

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

Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

The Safety Analysis population includes all participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants	OG00035 OG00145 OG00210

Title

Denominators

Categories

Any Local Symptom

Title	Measurements
None	OG00015 OG00122 OG00210
Mild

Primary

Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants

The Safety Analysis population includes all participants who received at least one study vaccination. No participants met the baseline ZIKV seropositive and DENV seronegative criteria.

Posted

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants

The Safety Analysis population includes all participants who received at least one study vaccination. No participants met the baseline ZIKV seropositive and DENV seronegative criteria.

Posted

Day 29 though Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for All Participants

The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

The Safety Analysis population includes all participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for All Participants

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seronegative participants who received at least one study vaccination. No subjects met the baseline ZIKV seropositive and DENV seronegative criteria.

Posted

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants

Posted

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Solicited Systemic Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Unsolicited Adverse Events by Treatment Group for All Participants

Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). If a condition was present at screening, it was not considered an AE unless the severity worsened.

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 57

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units

Primary

Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 57

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative Participants

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 57

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 57

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seropositive and DENV Seronegative Participants

Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each participant was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened.

The Safety Analysis population includes all baseline ZIKV seropositvie and DENV seronegative participants who received at least one study vaccination. No subjects met the baseline ZIKV seropositive and DENV seronegative criteria.

Posted

Day 1 through Day 57

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seropositive Participants

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 57

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Severity of Unsolicited Adverse Events by Treatment Group for Baseline ZIKV Seronegative and DENV Seronegative Participants

The Safety Analysis population includes all participants baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 57

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Primary

Frequency and Type of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants

SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.

The Safety Analysis population includes all with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

Duration of Serious Adverse Events (SAE) Considered Related to Study Vaccine for All Participants

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

Frequency and Type of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants

For this study Neurologic and Neuroinflammatory Disorders after the first vaccination were considered as Adverse Events of Special Interest (AESI).

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Duration of Adverse Events of Special Interest (AESI) Considered Related to Study Vaccine for All Participants

For this study Neurologic and Neuroinflammatory Disorders after the first vaccination were considered as Adverse Events of Special Interest (AESI).

The Safety Analysis population includes all participants with available results who received at least one study vaccination. No AESIs were reported.

Posted

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Frequency of New Onset Chronic Medical Conditions for All Participants

New onset chronic medical conditions (NOCMCs) were any new medical conditions reported from the first administration of study vaccine until the end of the study.

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.

Units	Counts
Participants	OG000

Primary

Comparison of the Frequency and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.

Units	Counts
Participants	OG000

Primary

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.

Units	Counts
Participants	OG000

Primary

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV positive and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.

Units	Counts
Participants	OG000

Primary

Comparison of the Frequency, Type, and Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive and DENV Seronegative Participants

The number of participants experiencing each adverse event and the median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seronegative participants who received at least one study vaccination. No participants met the baseline ZIKV seropositive and DENV seronegative criteria.

Posted

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units

Primary

Comparison of the Frequency, Type, and Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive and DENV Seronegative Participants

The number of participants experiencing each adverse event and the median duration of adverse events are listed.

Posted

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units

Primary

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

The number of participants experiencing each adverse event will be listed

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

The number of participants experiencing each adverse event are listed.

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for All Participants

The median duration of adverse events are listed.

The Safety Analysis population includes all participants with available results who received at least one study vaccination and experienced an event as reported in Outcome Measure 41.

Posted

Median

Full Range

Days

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for All Participants

The median duration of adverse events are listed.

The Safety Analysis population includes all participants with available results who received at least one study vaccination and experienced an event as reported in Outcome Measure 42.

Posted

Median

Full Range

Days

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 1 for Baseline ZIKV Seropositive Participants

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 43.

Posted

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of the Duration and Type of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seropositive Participants

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 44.

Posted

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 45.

Posted

Median

Full Range

Days

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 46.

Posted

Median

Full Range

Days

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 47.

Posted

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV positive and DENV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 48.

Posted

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 51.

Posted

Median

Full Range

Days

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

Comparison of the Duration and Type Duration of Vaccine-related Grade 3 Local, Systemic, or Laboratory AE, and Grade 2 or Greater Local or Systemic Reactogenicity Post Dose 2 for Baseline ZIKV Seronegative and DENV Seropositive Participants

The median duration of adverse events are listed.

Posted

Median

Full Range

Days

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

The median duration of adverse events are listed.

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination and experienced an event as reported in Outcome Measure 53.

Posted

Median

Full Range

Days

Day 1 through Day 8

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

The median duration of adverse events are listed.

Posted

Median

Full Range

Days

Day 29 through Day 36

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts

Primary

Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for All Participants

Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.

The Safety Analysis population includes all participants with available results who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive Participants

Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.

The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative Participants

Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.

The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seropositive Participants

Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.

The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seropositive and DENV Seronegative Participants

Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.

Posted

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seropositive Participants

Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seropositive participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Primary

Comparison of Study Withdrawals and Discontinuation of Study Vaccination Due to Any Reason for Baseline ZIKV Seronegative and DENV Seronegative Participants

Comparisons of the number of participants who withdrew early and who discontinued treatment are presented.

The Safety Analysis population includes all baseline ZIKV seronegative and DENV seronegative participants who received at least one study vaccination.

Posted

Count of Participants

Participants

Day 1 through Day 750

ID	Title	Description
OG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.
OG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected35 at risk EG0014 events4 affected45 at risk EG0020 events0 affected10 at risk
Eye pain	Eye disorders	Non-systematic Assessment	EG0002 events2 affected35 at risk EG0013 events3 affected45 at risk EG0020 events0 affected10 at risk
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected35 at risk EG0013 events3 affected45 at risk EG0020 events0 affected10 at risk
Toothache	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected35 at risk EG0010 events0 affected45 at risk EG0020 events0 affected10 at risk
Feeling hot	General disorders	Non-systematic Assessment	EG0004 events4 affected35 at risk EG0015 events5 affected45 at risk EG0021 events1 affected10 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0003 events3 affected35 at risk EG0010 events0 affected45 at risk EG0020 events0 affected10 at risk
Febrile infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected35 at risk EG0011 events1 affected45 at risk EG0022 events1 affected10 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0005 events5 affected35 at risk EG0015 events5 affected45 at risk EG0021 events1 affected10 at risk
Viral infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected35 at risk EG0013 events3 affected45 at risk EG0020 events0 affected10 at risk
Blood pressure diastolic decreased	Investigations	Systematic Assessment	EG0002 events2 affected35 at risk EG0014 events3 affected45 at risk EG0020 events0 affected10 at risk
Blood pressure systolic decreased	Investigations	Systematic Assessment	EG0004 events3 affected35 at risk EG0011 events1 affected45 at risk EG0020 events0 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected35 at risk EG0016 events5 affected45 at risk EG0020 events0 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected35 at risk EG0017 events6 affected45 at risk EG0020 events0 affected10 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0005 events5 affected35 at risk EG0018 events7 affected45 at risk EG0021 events1 affected10 at risk
Lethargy	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected35 at risk EG0011 events1 affected45 at risk EG0021 events1 affected10 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected35 at risk EG0010 events0 affected45 at risk EG0021 events1 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0006 events3 affected35 at risk EG00117 events7 affected45 at risk EG0022 events1 affected10 at risk

Term	Organ System	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected35 at risk EG0010 events0 affected45 at risk EG0020 events0 affected10 at risk
Overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected35 at risk EG0010 events0 affected45 at risk EG0021 events1 affected10 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected35 at risk EG0010 events0 affected45 at risk EG0020 events0 affected10 at risk
Major depression	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected35 at risk EG0010 events0 affected45 at risk EG0020 events0 affected10 at risk
Schizoaffective disorder bipolar type	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected35 at risk EG0010 events0 affected45 at risk EG0020 events0 affected10 at risk
Ovarian mass	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected35 at risk EG0011 events1 affected45 at risk EG0020 events0 affected10 at risk

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections
D014777	Virus Diseases
D018177	Flavivirus Infections
D018178	Flaviviridae Infections
D012327	RNA Virus Infections

ID	Title	Description
BG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).
BG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).
BG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29. Normal saline (0.9% sodium chloride injection, USP) is a clear to colorless, sterile, nonpyrogenic, isotonic solution.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	2.5 mcg ZPIV	2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	0	35	2	35	20	35
EG001	5 mcg ZPIV	5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	0	45	1	45	29	45
EG002	Placebo	Placebo administered intramuscularly on Day 1 and Day 29.	1	10	1	10	5	10