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The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose
This is an open label, non-randomized multi-center phase 3 follow-up study. All volunteers having completed trial IC51-304 (NCT00595790) will be enrolled into this trial at 2 sites
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC51 | Other | In study IC51-305, subjects who had received IC51 in study IC51-304 were tested for seroconversion 6 months after the first vaccination. Subjects who had protective titers were again tested for persistence of immunity at 12 months after the first immunization,whereas subjects who had titers below the seroconversion threshold by Month 6 received a booster dose of 1x6 mcg IC51 at Month 11. Their immune response was also assessed at Month 12. Thereafter, subjects who had no protective titer by Month 12 received a booster dose of 1x6 mcg IC51 at Month 23, regardless of prior treatment; and neutralizing antibody titers were reassessed at Month 24. Subjects who had protective titers at month 12 did not receive a booster at Month 23, and their neutralizing antibody titer was also assessed at Month 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC51 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination | Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:
| - 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| SPR 24 Months After the Primary Vaccination (Observed) | Persistence of immunogenicity (SPR) at M24 (observed) defined as :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Eder | Valneva Austria GmbH | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 2 x 6 µg | treatment group in preceeding study IC51-304 |
| FG001 | IC51 1 x 12 µg | treatment group in preceeding study IC51-304 |
| FG002 | IC51 1 x 6 µg | treatment group in preceeding study IC51-304 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 2 x 6 µg | treatment group in preceeding study IC51-304 |
| BG001 | IC51 1 x 12 µg | treatment group in preceeding study IC51-304 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination | Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:
| ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304 | Posted | Number | 95% Confidence Interval | percentage of participants | - 24 months |
|
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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 2 x 6 µg | treatment group in preceeding study IC51-304 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatique | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Research | Intercell AG | +43 1 206 20 | 0 | kdubischar.kastner@intercell.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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| 24 months |
| Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination | - 24 months |
| Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination | 24 months |
| SCR 1 Month After the Booster Doses | 1 month |
| GMT 1month After Booster Doses | 1 month |
| Safety Profile of IC51 | study duration |
| BG002 | IC51 1 x 6 µg | treatment group in preceeding study IC51-304 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | IC51 2 x 6 µg | treatment group in preceeding study IC51-304 |
| OG001 | IC51 1 x 12 µg | treatment group in preceeding study IC51-304 |
| OG002 | IC51 1 x 6 µg | treatment group in preceeding study IC51-304 |
|
|
| Secondary | SPR 24 Months After the Primary Vaccination (Observed) | Persistence of immunogenicity (SPR) at M24 (observed) defined as :
| Not Posted | 24 months |
| Secondary | Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination | Not Posted | - 24 months |
| Secondary | Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination | Not Posted | 24 months |
| Secondary | SCR 1 Month After the Booster Doses | Not Posted | 1 month |
| Secondary | GMT 1month After Booster Doses | Not Posted | 1 month |
| Secondary | Safety Profile of IC51 | Not Posted | study duration |
| 4 |
| 116 |
| 61 |
| 116 |
| EG001 | IC51 1 x 12 µg | treatment group in preceeding study IC51-304 | 4 | 117 | 69 | 117 |
| EG002 | IC51 1 x 6 µg | treatment group in preceeding study IC51-304 | 3 | 116 | 64 | 116 |
| Facial Bones Fracture | Injury, poisoning and procedural complications |
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| Hand Fracture | Injury, poisoning and procedural complications |
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| Tendon Injury | Injury, poisoning and procedural complications |
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| Back Pain | Musculoskeletal and connective tissue disorders |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders |
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| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Urinary Incontinence | Renal and urinary disorders |
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| Uterine Prolapse | Reproductive system and breast disorders |
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| Paranasal Sinus Discomfort | Respiratory, thoracic and mediastinal disorders |
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| Hysterectomy | Surgical and medical procedures |
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| Influenza Like Ilness | General disorders |
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| Nasopharyngitis | Infections and infestations |
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| Headache | Nervous system disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Toothache | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Sinusitis | Infections and infestations |
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| Accidental Poisoning | Injury, poisoning and procedural complications |
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| Back Pain | Musculoskeletal and connective tissue disorders |
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| Myalgia | Musculoskeletal and connective tissue disorders |
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| Dysmenorrhoea | Reproductive system and breast disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Anaemia | Blood and lymphatic system disorders |
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| Lymphadenopathy | Blood and lymphatic system disorders |
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| Abdominal Pain Upper | Gastrointestinal disorders |
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| Induration | General disorders |
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| Injection Site Pain | General disorders |
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| Herpes Zoster | Infections and infestations |
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| Lower Respiratory Tract Infection | Infections and infestations |
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| Pharyngitis | Infections and infestations |
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| Procedural Pain | Injury, poisoning and procedural complications |
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| Haematocrit Decreased | Investigations |
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| Haemoglobin Decreased | Investigations |
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| Red Blood Cell Count Decreased | Investigations |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders |
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| Hypoaesthesia | Nervous system disorders |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders |
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| Eczema | Skin and subcutaneous tissue disorders |
|
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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 |