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This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVGH Vi-CRM197 conjugate vaccine | Experimental |
| |
| Vi-polysaccharide vaccine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Typherix | Biological | 1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any Post Immunization Reactions | Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue. | During the 7-day period after vaccination |
| Number of Subjects Reporting Adverse Events | During the 28-day period after vaccination | |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | During the 6-month period after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Vi ELISA Geometric Mean Concentration (GMC) | At 28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre VanDamme, Dr. | Center for the Evaluation of Vaccination (CEV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for the Evaluation of Vaccination (CEV) | Antwerp | Wilrijk (Antwerp) | 2610 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21980445 | Result | van Damme P, Kafeja F, Anemona A, Basile V, Hilbert AK, De Coster I, Rondini S, Micoli F, Qasim Khan RM, Marchetti E, Di Cioccio V, Saul A, Martin LB, Podda A. Safety, immunogenicity and dose ranging of a new Vi-CRM(1)(9)(7) conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS One. 2011;6(9):e25398. doi: 10.1371/journal.pone.0025398. Epub 2011 Sep 30. |
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First subject enrolled: 03 MAY 2010 Last subject completed: 09 NOV 10 All subjects were enrolled at 1 center in Belgium
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| ID | Title | Description |
|---|---|---|
| FG000 | NVGH Vi-CRM197 | 1 dose of 0.5 mL containing 25 mcg of Vi-CRM |
| FG001 | Typherix | 1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NVGH Vi-CRM197 | 1 dose of 0.5 mL containing 25 mcg of Vi-CRM |
| BG001 | Typherix | 1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide |
| 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 | Number of Subjects Reporting Any Post Immunization Reactions | Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue. | Posted | Number | participants | During the 7-day period after vaccination |
|
AE during 28 days following vaccination (SAE for 6 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 | NVGH Vi-CRM197 | 1 dose of 0.5 mL containing 25 mcg of Vi-CRM |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SPONTANEOUS PNEUMOTHORAX RIGHT SIDE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Audino Podda, MD | Novartis Vaccines Institute for Global Health | +39 0577 243496 | audino.podda@novartis.com |
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| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| NVGH Vi-CRM197 |
| Biological |
1 dose of 0.5 mL containing 25 mcg of Vi-CRM |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Anti-Vi ELISA Geometric Mean Concentration (GMC) | Posted | Geometric Mean | 95% Confidence Interval | ELISA Units/mL | At 28 days after vaccination |
|
|
|
| Primary | Number of Subjects Reporting Adverse Events | Posted | Number | participants | During the 28-day period after vaccination |
|
|
|
| Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) | Posted | Number | participants | During the 6-month period after vaccination |
|
|
|
| 0 |
| 25 |
| 23 |
| 25 |
| EG001 | Typherix | 1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide | 2 | 25 | 16 | 25 |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| malaise | General disorders | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| injection site induration | General disorders | Systematic Assessment |
|
| injection site erythema | General disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| muscoloskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |