Trial · NCT00605085

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

NCT00605085, Phase 3, Completed, Valneva Austria GmbH; results first posted 2012-11-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Trials, record NCT00605085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00605085

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Trial

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

Title: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
NCT number: NCT00605085
Status: Completed
Phases: Phase 3
Enrollment: 2,675 participants, actual
Lead sponsor: Valneva Austria GmbH
Conditions: Japanese Encephalitis
Interventions: Japanese Encephalitis purified inactivated vaccine (IC51), Placebo
First posted: 2008-01-30
Last updated: 2024-03-21
Results first posted: 2012-11-20

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Safety and Tolerability up to Day 56	Day 56	calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Secondary	Rates of Serious Adverse Events and Medically Attended Adverse Events	until Day 56
Secondary	Changes in Laboratory Parameters	until Day 56
Secondary	SCR and GMT of Subjects With Concomitant Vaccinations	until Day 56

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety and Tolerability up to Day 56	Day 56	Safety Population	percentage of participants with AEs	NUMBER
SECONDARY	Rates of Serious Adverse Events and Medically Attended Adverse Events	until Day 56
SECONDARY	Changes in Laboratory Parameters	until Day 56
SECONDARY	SCR and GMT of Subjects With Concomitant Vaccinations	until Day 56

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Safety and Tolerability up to Day 56	IC51		58.9		percentage of participants with AEs
Safety and Tolerability up to Day 56	Placebo		56.6		percentage of participants with AEs

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	IC51	2,012
Overall Study	STARTED	Placebo	663
Overall Study	COMPLETED	IC51	1,962
Overall Study	COMPLETED	Placebo	638
Overall Study	NOT COMPLETED	IC51	50
Overall Study	NOT COMPLETED	Placebo	25

Source ClinicalTrials.gov

Adverse events44

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
other	Nausea	Gastrointestinal disorders	IC51	131	1,993
other	Nausea	Gastrointestinal disorders	Placebo	49	657
other	Fatigue	General disorders	IC51	227	1,993
other	Fatigue	General disorders	Placebo	77	657
other	Influenza Like Illness	General disorders	IC51	248	1,993
other	Influenza Like Illness	General disorders	Placebo	78	657
other	Pyrexia	General disorders	IC51	64	1,993
other	Pyrexia	General disorders	Placebo	20	657
other	Nasopharyngitis	Infections and infestations	IC51	94	1,993
other	Nasopharyngitis	Infections and infestations	Placebo	26	657

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IC51
Total, all-cause mortality	Placebo
Total, other adverse events	IC51	917	1,993
Total, other adverse events	Placebo	292	657
Total, serious adverse events	IC51	10	1,993
Total, serious adverse events	Placebo	6	657

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
IC51 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.

GET https://conductscience.org/api/trials/v1/NCT00605085

GET https://conductscience.org/api/trials/v1/NCT00605085/events?page=2

API reference For AI assistants