Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment | Other | subjects will be followed up on immunity (analysis of blood samples) and safety |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Procedure | blood draw at Month 12, Month 24 and Month 36. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322) | Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322) | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea Ayad, Dr. | Valneva Austria GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa | Florida | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32156630 | Derived | Taucher C, Barnett ED, Cramer JP, Eder-Lingelbach S, Jelinek T, Kadlecek V, Kiermayr S, Mills DJ, Pandis D, Reiner D, Dubischar KL. Neutralizing antibody persistence in pediatric travelers from non-JE-endemic countries following vaccination with IXIARO(R) Japanese encephalitis vaccine: An uncontrolled, open-label phase 3 follow-up study. Travel Med Infect Dis. 2020 Mar-Apr;34:101616. doi: 10.1016/j.tmaid.2020.101616. Epub 2020 Mar 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment | subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 has given in the parent study IC51-322: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IC51 has given in the parent study IC51-322 |
| Biological |
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. |
|
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) | 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 |
| 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). | 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). | Months 12, 24 and 36 |
| Brisbane |
| Australia |
| Melbourne | Australia |
| Berlin | Germany |
| Hamburg | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Treatment | subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322) | Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322) | intention to treat population; assessment of seroprotection ~1 year post primary vaccination series in parent study IC51-322 | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
|
|
| |||||||||||||||||||||||||
| Secondary | GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) | GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322) | Intent to Treat Population | Posted | Geometric Mean | 95% Confidence Interval | Titer | Month 12, 24 and 36 |
|
| ||||||||||||||||||||||||||
| Secondary | Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322) | Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322) | Intent to Treat Population | Posted | Number | percentage of participants | Month 24, 36 |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322) | Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322) | Safety Population | Posted | Count of Participants | Participants | Months 12, 24 and 36 |
|
| |||||||||||||||||||||||||||
| Secondary | 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). | 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). | Safety Population | Posted | Count of Participants | Participants | Months 12, 24 and 36 |
|
|
adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Treatment | subjects will be followed up on immunity (analysis of blood samples) and safety Blood draw: blood draw at Month 12, Month 24 and Month 36. IC51 was given in the parent study IC51-322: 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. | 2 | 23 | 8 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Staphylococcal infection | Infections and infestations |
| |||
| Tonsillitis | Infections and infestations |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis media acute | Infections and infestations |
| |||
| Pharyngitis streptococcal | Infections and infestations |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Skin papilloma | Skin and subcutaneous tissue disorders |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Scientist Clinical Research | Valneva Austria GmbH | +43120620 | 0 | info@valneva.com |
| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
|
|
|
|