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The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440
This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
192 subjects will be enrolled at 2 sites in Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC51 and Placebo | Active Comparator | 6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) |
|
| HAVRIX and placebo | Active Comparator | HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) |
|
| IC51 and HAVRIX | Active Comparator | IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC51 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies | anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section | Day 56 |
| GMT for Hepatitis A Virus (HAV) Antibody at Day 28 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28 | day 28 and 56 | |
| GMT and SCR for PRNT at Day 28 and HAV at Day 56 | day 28 and 56 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Kaltenboeck, Ph.D. | Valneva Austria GmbH | Study Director |
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First Subject In: 26.09.2005, Last Subject Out: 14.07.2006 performed at centers for travelling medicine/vaccinology
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 and Placebo | 6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) |
| FG001 | HAVRIX and Placebo | HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) |
| FG002 | IC51 and HAVRIX | IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 and Placebo | 6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) |
| BG001 | HAVRIX and Placebo | HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) |
| 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 | Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies | anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section | Per Protocol Population includes all randomized subjects without major protocol deviations | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 56 |
|
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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 and Placebo | 6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatique | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrin Dubischar-Kastner | Valneva Austria GmbH | +43 1 206 20 | 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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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| HAVRIX | Biological |
|
| Placebo | Other |
|
| Safety |
Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis) |
| until 6 month after last vaccination |
| BG002 | IC51 and HAVRIX | IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28 | Not Posted | day 28 and 56 |
| Secondary | GMT and SCR for PRNT at Day 28 and HAV at Day 56 | Not Posted | day 28 and 56 |
| Secondary | Safety | Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis) | Not Posted | until 6 month after last vaccination |
| Primary | GMT for Hepatitis A Virus (HAV) Antibody at Day 28 | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 |
|
|
|
|
| 1 |
| 65 |
| 27 |
| 65 |
| EG001 | HAVRIX and Placebo | HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) | 0 | 65 | 31 | 65 |
| EG002 | IC51 and HAVRIX | IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) | 0 | 62 | 24 | 62 |
| Influenza like illness | General disorders |
|
| Pyrexia | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Cystitis | Infections and infestations |
|
| Rhinitis | Infections and infestations |
|
| Bronchitis | Infections and infestations |
|
| Gastrointeritis | Infections and infestations |
|
| Rash pustular | Infections and infestations |
|
| Headache | Nervous system disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Hepatic enzyme increased | Investigations |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| Vertigo | Ear and labyrinth disorders |
|
| Myalgia | Musculoskeletal and connective 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 |
| D045424 |
| Complex Mixtures |