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The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese Encephalitis purified inactivated vaccine | Biological | Japanese Encephalitis purified inactivated vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302 | 24 months after the first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | 6, 12, 36, 48 and 60 months after 1st vaccination | |
| Geometric Mean Titers | 6, 12, 36, 48 and 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 3,300 subjects having completed IC51, JE-VAX or placebo treatment in studies IC51-301 or IC51-302 will take part in the safety follow up, up to month 6 after 1st vaccination in the study IC51-301 (NCT00604708) or IC51-302 (NCT00605085).
Only ~160 subjects, who have been treated with IC51 will take part in the immunogenicity and long-term analysis up to month 60.
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| Name | Affiliation | Role |
|---|---|---|
| Evelyn Hatzenbichler, Ph.D. | Valneva Austria GmbH | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30962094 | Derived | Taucher C, Kollaritsch H, Dubischar KL. Persistence of the immune response after vaccination with the Japanese encephalitis vaccine, IXIARO(R) in healthy adults: A five year follow-up study. Vaccine. 2019 May 1;37(19):2529-2531. doi: 10.1016/j.vaccine.2019.03.030. Epub 2019 Apr 5. |
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study participants were recruited from 44 study centers previously participating in study IC51-301 and IC51-302
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302 |
| FG001 | JE-VAX | no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301 |
| FG002 | Placebo | no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Up to Month 6 |
| |||||||||||||
| Up to Month 60 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302 |
| BG001 | JE-VAX | no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302 | subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study | Posted | Number | 95% Confidence Interval | percentage of subjects | 24 months after the first vaccination |
|
|
all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60
group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IC51 Month 6 | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrin Dubischar-Kastner | Valneva Austria GmbH | +43 1 20620 | 0 | info@valneva.com |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| Adverse Events | 6, 12, 24, 36, 48 and 60 months after 1st vaccination |
| NOT COMPLETED |
|
| BG002 | Placebo | no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Participants |
|
|
| Secondary | Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) | Not Posted | 6, 12, 36, 48 and 60 months after 1st vaccination |
| Secondary | Geometric Mean Titers | Not Posted | 6, 12, 36, 48 and 60 months |
| Secondary | Adverse Events | Not Posted | 6, 12, 24, 36, 48 and 60 months after 1st vaccination |
| 15 |
| 2,283 |
| 78 |
| 2,283 |
| EG001 | JE-VAX | no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 | 2 | 338 | 16 | 338 |
| EG002 | Placebo | no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 | 7 | 637 | 31 | 637 |
| EG003 | IC51 Month 60 | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60 | 14 | 102 | 54 | 102 |
| Abdominal Pain Lower | Gastrointestinal disorders |
|
| Appendix Disorder | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Appendiceal Abscess | Infections and infestations |
|
| Appendicitis | Infections and infestations |
|
| Diverticulitis | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Pyelonephritis | Infections and infestations |
|
| Sepsis | Infections and infestations |
|
| Head Injury | Injury, poisoning and procedural complications |
|
| Joint Ligament Rupture | Injury, poisoning and procedural complications |
|
| Tibia Fructure | Injury, poisoning and procedural complications |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders |
|
| Synovial Cyst | Musculoskeletal and connective tissue disorders |
|
| Adenocarinoma Pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Lung Adenocarcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Central Nervous System Inflammation | Nervous system disorders |
|
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions |
|
| Nephrolithiasis | Renal and urinary disorders |
|
| Ovarian Cyst | Reproductive system and breast disorders |
|
| Mediastinal Mass | Respiratory, thoracic and mediastinal disorders |
|
| Meniscus Operation | Surgical and medical procedures |
|
| Tonsillectomy | Surgical and medical procedures |
|
| Coronary Stenosis | Cardiac disorders |
|
| Abscess Soft Tissue | Infections and infestations |
|
| Endometritis | Infections and infestations |
|
| Tonsillitis | Infections and infestations |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications |
|
| Smear Cervix Abnormal | Investigations |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders |
|
| Toe Deformity | Musculoskeletal and connective tissue disorders |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Post Herpetic Neuralgia | Nervous system disorders |
|
| Urethral Stricture | Renal and urinary disorders |
|
| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders |
|
| Blood Donor | Social circumstances |
|
| Hypothyroidism | Endocrine disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Acute Tonsillitis | Infections and infestations |
|
| Bronchitis | Infections and infestations |
|
| Cystitis | Infections and infestations |
|
| Herpes Simplex | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Pyelonephritis | Infections and infestations |
|
| Tonsillitis | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Depression | Psychiatric disorders |
|
| Dental Implantation | Surgical and medical procedures |
|
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| 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 |