Blood draw
Procedureblood draw at Month 12, Month 24 and Month 36.
NCT Number: NCT01246479
The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.
Looking for future studies?
Notify Me9 month–20 year
All sexes
Interventional
Phase 3
Brisbane, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
blood draw at Month 12, Month 24 and Month 36.
No 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.
Time frame: Month 12
Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)
Time frame: Month 12, 24 and 36
GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
Time frame: Month 24, 36
Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)
Time frame: Months 12, 24 and 36
Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
Time frame: Months 12, 24 and 36
Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322).
Valneva Austria GmbH
Industry
Long Term Immunity and Safety Following Vaccination With the Japanese Encephalitis Vaccine IC51(IXIARO®, JESPECT®) In a Pediatric Population in Non Endemic Countries. Uncontrolled, Phase 3 Follow-up Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06331702
Arbovirus Infections, Brain Diseases
Nanjing, Jiangsu, China
View Trial DetailsNCT06372665
Arbovirus Infections, Brain Diseases
Nanjing, Jiangsu, China
View Trial DetailsNCT03920111
Arbovirus Infections, Brain Diseases
Liverpool, United Kingdom
View Trial DetailsNCT00604708
Arbovirus Infections, Brain Diseases
View Trial Details