CompletedNCT01047839Updated Jun 30, 2020Results posted

Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

A Phase 3 interventional study of IC51 and IC51 in Encephalitis, sponsored by Valneva Austria GmbH. Completed at 10 sites in 5 countries. Open to participants aged 2 Months to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by Valneva Austria GmbH · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 100
Allocation: Non-randomized
Ages: 2 Months to 17 Years
Sex: All

Study summary

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

Conditions studied

Encephalitis

Browse trials for

Keywords

Pediatric
Japanese Encephalitis Vaccine
non-endemic countries
to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51

In context

Encephalitis, Japanese

77 studies on the registry are indexed under Encephalitis, Japanese; 4 are open to participants now.

This study's enrollment of 100 is below the median of 278 across 69 interventional studies indexed under Encephalitis, Japanese.

Browse Encephalitis, Japanese studies →

Lead sponsor

Valneva Austria GmbH is the lead sponsor of 44 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Months to 17 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male or female healthy children and adolescents aged >=2 months to \<18 years at the time of first vaccination
Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion criteria

Exclusion Criteria:

Clinical manifestation or history of any Flavivirus disease
Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
History of immunodeficiency or immunosuppressive therapy
Known HIV, HBV or HCV infection
History of hypersensitivity reactions to other vaccines
Acute febrile infection at each visit during which the subject receives a vaccination
Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (actual)

Study arms

Experimental
>=2 months to <3 years
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
Biological: IC51
Experimental
>=3 to <12 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Biological: IC51
Experimental
>=12 to <18 years
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Biological: IC51

Interventions

BiologicalIC51
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
BiologicalIC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
BiologicalIC51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28

What researchers measure

Primary outcomes

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Time frame: until Day 56

Secondary outcomes

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Time frame: up to Month 7
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Time frame: 7 days
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Time frame: up to Day 56 and upt to Month 7
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
Time frame: up to Month 7
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
Time frame: at Day 56 and Month 7
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Time frame: at Day 56 and Month 7
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Time frame: at Day 56 and Month 7
GMTs at Day 56 and Month 7 Stratified According to Age Groups
Time frame: at Day 56 and Month 7

Results

Posted Dec 19, 2014

Participant flow

Participant flow — Overall Study
Milestone	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years
Started	12	29	59
Completed	10	29	53
Not completed	2	0	6

Outcome measures

PrimaryRate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination

Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.

Time frame:: until Day 56
Reported as:: Number · percentage of participants

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
percentage of participants	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination	33.3 (9.9 to 65.1)	20.7 (8.0 to 39.7)	3.4 (0.4 to 11.7)

SecondaryRate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination

Time frame:: up to Month 7
Reported as:: Number · percentage of participants

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
percentage of participants	IC51 0.25 mL	IC51 0.5 mL
SAEs	0 (0.0 to 26.5)	3.4 (0.7 to 9.6)
medically attended AEs	33.3 (9.9 to 65.1)	18.2 (10.8 to 27.8)

SecondaryRate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination

Time frame:: 7 days
Reported as:: Number · percentage of participants

Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
percentage of participants	IC51 0.25 mL	IC51 0.5 mL
any Local after 1st Vaccination	28.6 (2.1 to 48.4)	48.9 (38.1 to 59.8)
any Systemic after 1st Vaccination	33.3 (2.1 to 48.4)	46.0 (34.8 to 56.4)
any Local after 2nd Vaccination	22.2 (2.3 to 51.8)	29.4 (20.0 to 40.3)
any Systemic after 2nd Vaccination	28.6 (2.3 to 51.8)	22.6 (14.0 to 32.7)

SecondaryRate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination

Time frame:: up to Day 56 and upt to Month 7
Reported as:: Number · percentage of participants

Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
percentage of participants	IC51 0.25 mL	IC51 0.5 mL
any unsolicited AE up to Day 56	83.3 (51.6 to 97.9)	29.5 (20.3 to 40.2)
any unsolicited AE up to Month 7	91.7 (61.5 to 99.8)	43.2 (32.7 to 54.2)

SecondaryRate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination

Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.

Time frame:: up to Month 7
Reported as:: Count of participants · Participants

Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Participants	IC51 0.25 mL	IC51 0.5 mL
White Blood cells on Day 28	1	0
Platelets on Day 28	0	1

SecondarySCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)

Time frame:: at Day 56 and Month 7
Reported as:: Number · percentage of participants

SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
percentage of participants	IC51 0.25 mL	IC51 0.5 mL
SCR Day 56	100.0 (56.6 to 100.0)	100.0 (93.7 to 100.0)
SCR Month 7	100.0 (34.2 to 100.0)	90.6 (75.8 to 96.8)

SecondaryGMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7

Time frame:: at Day 56 and Month 7
Reported as:: Geometric mean · Titer

GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Titer	IC51 0.25 mL	IC51 0.5 mL
GMT Day 56	216.18 (105.97 to 441.00)	340.74 (269.83 to 430.28)
GMT Month 7	47.96 (0.00 to 3214485.72)	57.12 (38.41 to 84.94)

SecondarySCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups

Time frame:: at Day 56 and Month 7
Reported as:: Number · percentage of participants

SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
percentage of participants	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years
SCR Day 56	100 (56.6 to 100.0)	100.0 (79.6 to 100.0)	100.0 (91.6 to 100.0)
SCR Month 7	100.0 (34.2 to 100.0)	66.7 (20.8 to 93.9)	93.1 (78.0 to 98.1)

SecondaryGMTs at Day 56 and Month 7 Stratified According to Age Groups

Time frame:: at Day 56 and Month 7
Reported as:: Mean · Titer

GMTs at Day 56 and Month 7 Stratified According to Age Groups
Titer	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years
GMT Day 56	216.18 (105.97 to 441.0)	508.03 (267.76 to 963.90)	295.44 (235.96 to 369.90)
GMT Month 7	47.96 (0.00 to 3214485.72)	31.96 (0.48 to 2120.78)	60.65 (40.72 to 90.36)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
>=2 Months to <3 Years	—	0/12 (0%)	11/12 (91.7%)
>=3 to <12 Years	—	0/29 (0%)	22/29 (75.9%)
>=12 to <18 Years	—	3/59 (5.1%)	49/59 (83.1%)

Most frequent serious events

Most frequent serious events
Event	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years
Type 1 diabetes mellitusMetabolism and nutrition disorders	0/12	0/29	1/59
DizzinessNervous system disorders	0/12	0/29	1/59
Intentional self-injuryPsychiatric disorders	0/12	0/29	1/59

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years
TendernessGeneral disorders	1/12	13/29	31/59
Muscle PainGeneral disorders	0/12	4/29	23/59
NasopharyngitisInfections and infestations	4/12	4/29	0/59
Injection Site PainGeneral disorders	0/12	3/29	19/59
PyrexiaGeneral disorders	3/12	2/29	1/59
RednessGeneral disorders	3/12	2/29	2/59
IrritabilityGeneral disorders	0/12	5/29	1/59
CoughRespiratory, thoracic and mediastinal disorders	2/12	3/29	1/59
LymphadenopathyBlood and lymphatic system disorders	2/12	3/29	0/59
DiarrhoeaGastrointestinal disorders	2/12	1/29	2/59

Baseline characteristics

Age, Continuous
Age, Continuous(years)	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years	Total
Mean	1.81 ± 0.811	6.98 ± 2.417	15.90 ± 1.176	11.62 ± 5.605

Sex: Female, Male
Sex: Female, Male(Participants)	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years	Total
Female	5	12	36	53
Male	7	17	23	47

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	>=2 Months to <3 Years	>=3 to <12 Years	>=12 to <18 Years	Total
American Indian or Alaska Native	0	0	0	0
Asian	3	5	5	13
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	1	2	0	3
White	8	22	53	83
More than one race	0	0	0	0
Unknown or Not Reported	0	0	1	1

Study locations

10 sites

Tampa Clinical Research Inc.
Tampa, Florida 33624, United States
Passport Health
Baltimore, Maryland 21230, United States
Boston Medical Center
Boston, Massachusetts 02118, United States
Bronx Lebanon Hospital Center
New York, New York 10457, United States
Dr. Deb - The Travel Doctor
Brisbane, Queensland 4001, Australia
Travel Doctor - TMVC Australia
Melbourne, Victoria 3000, Australia
Danske Laegers Forsknings Center
Soborg, 2860, Denmark
Berliner Zentrum für Reise- und Tropenmedizin
Berlin, 10117, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
City Akuten Wasa Vaccination
Stockholm, 11136, Sweden

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01047839
Lead sponsor: Valneva Austria GmbH
Responsible party: Sponsor
First posted: Jan 13, 2010
Start date: Jan 2010
Primary completion: Aug 2013
Completion: Aug 2013
Results posted: Dec 19, 2014
Last update: Jun 30, 2020

Study contacts

Andrea Ayad, Dr.

study chair · Valneva Austria GmbH

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Encephalitis, Japanese→

Other studies from this sponsor

Valneva Austria GmbH

Start the discussion