Trial · NCT00314132

Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

NCT00314132, Phase 3, Completed, Sanofi; results first posted 2012-12-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis. Trials, record NCT00314132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00314132

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
NCT number: NCT00314132
Status: Completed
Phases: Phase 3
Enrollment: 2,004 participants, actual
Lead sponsor: Sanofi
Conditions: Encephalitis, Japanese Encephalitis
Interventions: ChimeriVax-JE, Japanese Encephalitis vaccine, 0.9% Saline
First posted: 2006-04-13
Last updated: 2012-12-06
Results first posted: 2012-12-05

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).	Participants	NUMBER
PRIMARY	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 and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).	Participants	NUMBER

Source ClinicalTrials.gov

Results by group80

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	Placebo	Fatigue	90	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	ChimeriVax™-JE 4 log10 PFU Vaccine	Fatigue	365	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	Placebo	Malaise	69	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	ChimeriVax™-JE 4 log10 PFU Vaccine	Malaise	297	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	Placebo	Injection Site Pain	36	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	ChimeriVax™-JE 4 log10 PFU Vaccine	Injection Site Pain	199	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	Placebo	Feeling Hot	27	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	ChimeriVax™-JE 4 log10 PFU Vaccine	Feeling Hot	152	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	Placebo	Chills	17	Participants
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo	ChimeriVax™-JE 4 log10 PFU Vaccine	Chills	112	Participants

1 to 10 of 80Source ClinicalTrials.gov

See all 80 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	403
Overall Study	STARTED	ChimeriVax™-JE 4 log10 PFU Vaccine	1,601
Overall Study	COMPLETED	Placebo	395
Overall Study	COMPLETED	ChimeriVax™-JE 4 log10 PFU Vaccine	1,583
Overall Study	NOT COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	ChimeriVax™-JE 4 log10 PFU Vaccine	18

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Placebo	36	403	42
other	Diarrhea	Gastrointestinal disorders	ChimeriVax™-JE 4 log10 PFU Vaccine	183	1,601	251
other	Nausea	Gastrointestinal disorders	Placebo	37	403	50
other	Nausea	Gastrointestinal disorders	ChimeriVax™-JE 4 log10 PFU Vaccine	164	1,601	228
other	Abdominal Pain	Gastrointestinal disorders	Placebo	26	403	33
other	Abdominal Pain	Gastrointestinal disorders	ChimeriVax™-JE 4 log10 PFU Vaccine	138	1,601	219
other	Chills	General disorders	Placebo	26	403	38
other	Chills	General disorders	ChimeriVax™-JE 4 log10 PFU Vaccine	147	1,601	193
other	Feeling Hot	General disorders	Placebo	35	403	55
other	Feeling Hot	General disorders	ChimeriVax™-JE 4 log10 PFU Vaccine	193	1,601	281

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	ChimeriVax™-JE 4 log10 PFU Vaccine
Total, other adverse events	Placebo	124	403
Total, other adverse events	ChimeriVax™-JE 4 log10 PFU Vaccine	597	1,601
Total, serious adverse events	Placebo	2	403
Total, serious adverse events	ChimeriVax™-JE 4 log10 PFU Vaccine	5	1,601

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20934459	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
ChimeriVax™-JE 4 log10 PFU Vaccine vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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