Encephalitis, Japanese Encephalitis
Conditions
Keywords
Japanese Encephalitis, Encephalitis virus, ChimeriVax™-JE Vaccine
Brief summary
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
Interventions
BIOLOGICALChimeriVax-JE, Japanese Encephalitis vaccine
0.5 mL, Subcutaneous
BIOLOGICAL0.9% Saline
0.5 mL, Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Informed consent obtained from the subject. * Aged 18 years or above at screening. * In good general health * Subject available for the study duration * For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.
Exclusion criteria
* A history of vaccination against or infection with JE. * Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs. * History of thymoma, thymic surgery (removal) or myasthenia gravis. * Clinically significant abnormalities on laboratory assessment * Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines). * Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30. * Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30. * Physical examination indicating any clinically significant medical condition. * Oral temperature \>38°C (100.4°F) or acute illness within 3 days prior to inoculation. * Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30. * Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen. * Lactation or intended pregnancy in female subjects. * Excessive alcohol consumption, drug abuse, significant psychiatric illness. * A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges). * Participation in another clinical study within 30 days of the screening visit for this study. * Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study. * Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Day 0 up to 30 days post-vaccination | Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered actively solicited through Day 30. |
| Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Day 0 up to 30 days post-vaccination | Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported. |
Countries
Australia, United States
Participant flow
Recruitment details
Participants were enrolled and vaccinated from 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US.
Pre-assignment details
A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a single injection of placebo on Day 0. | 403 |
| ChimeriVax™-JE 4 log10 PFU Vaccine Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0. | 1,601 |
| Total | 2,004 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 13 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Placebo | ChimeriVax™-JE 4 log10 PFU Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 403 Participants | 1601 Participants | 2004 Participants |
| Age Continuous | 34.8 Years STANDARD_DEVIATION 14.12 | 34.6 Years STANDARD_DEVIATION 14.25 | 34.7 Years STANDARD_DEVIATION 14.22 |
| Region of Enrollment Australia | 140 Participants | 400 Participants | 540 Participants |
| Region of Enrollment United States | 263 Participants | 1201 Participants | 1464 Participants |
| Sex: Female, Male Female | 165 Participants | 721 Participants | 886 Participants |
| Sex: Female, Male Male | 238 Participants | 880 Participants | 1118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 124 / 403 | 597 / 1,601 |
| serious Total, serious adverse events | 2 / 403 | 5 / 1,601 |
Outcome results
Primary
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
Time frame: Day 0 up to 30 days post-vaccination
Population: Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pain | 36 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Erythema | 15 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pruritus | 12 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Hemorrhage | 4 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Swelling | 4 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Reaction | 3 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Rash | 3 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Induration | 0 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Joint Pain | 0 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Paresthesia | 1 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Stinging | 0 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Warmth | 0 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Fatigue | 112 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Malaise | 92 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Chills | 26 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Pyrexia | 7 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Headache | 124 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Myalgia | 67 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Arthralgia | 28 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Diarrhea | 36 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Nausea | 37 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Vomiting | 12 Participants |
| Placebo | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Rash | 13 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Warmth | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pain | 199 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Myalgia | 352 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Erythema | 74 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Fatigue | 479 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pruritus | 66 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Nausea | 164 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Hemorrhage | 21 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Malaise | 383 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Swelling | 17 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Arthralgia | 179 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Reaction | 10 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Chills | 147 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Rash | 5 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Rash | 34 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Induration | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Pyrexia | 26 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Joint Pain | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Diarrhea | 183 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Paresthesia | 0 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Headache | 597 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Stinging | 1 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo | Vomiting | 37 Participants |
Primary
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered actively solicited through Day 30.
Time frame: Day 0 up to 30 days post-vaccination
Population: Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Malaise | 69 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Arthralgia | 21 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Erythema | 14 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Diarrhea | 25 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Feeling Hot | 27 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Nausea | 26 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pruritus | 11 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Abdominal Pain | 21 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pain | 36 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Pharyngolaryngeal Pain | 10 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Headache | 99 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Dyspnea | 10 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Chills | 17 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Nasal Congestion | 9 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Myalgia | 48 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Nasopharyngitis | 13 Participants |
| Placebo | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Fatigue | 90 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Nasopharyngitis | 10 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Fatigue | 365 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Malaise | 297 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pain | 199 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Feeling Hot | 152 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Chills | 112 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Erythema | 74 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Injection Site Pruritus | 64 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Headache | 417 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Myalgia | 265 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Arthralgia | 119 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Diarrhea | 140 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Nausea | 114 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Abdominal Pain | 89 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Pharyngolaryngeal Pain | 55 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Dyspnea | 53 Participants |
| ChimeriVax™-JE 4 log10 PFU Vaccine | Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo | Nasal Congestion | 14 Participants |