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IC51 has given in the parent study IC51-322

Phase 3

Japanese Encephalitis | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Mar 18, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

IC51 has given in the parent study IC51-322 · 1 trial · 1 indication

Phase 3 1
NCT01246479Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-StudyJapanese Encephalitis
COMPLETED23 Analytics
PHASE3COMPLETED
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
Japanese Encephalitis
NCT0124647923
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Study Endpoints

Primary Endpoints

Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)
Month 12

Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)

Secondary Endpoints

GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Month 12, 24 and 36
Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Month 24, 36
Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
Months 12, 24 and 36
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
No treatmentOTHERsubjects will be followed up on immunity (analysis of blood samples) and safety

Interventions

NameTypeDescription
Blood drawPROCEDUREblood draw at Month 12, Month 24 and Month 36.
IC51 has given in the parent study IC51-322BIOLOGICALNo more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
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Eligibility Criteria

Age Range9 Months to 20 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322. * Male or female healthy subjects aged ≥ 9 months to \< 21 years at the time of enrolment into this study. * Written informed...

Countries:United StatesAustraliaGermany
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