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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021874-12 | EudraCT Number |
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This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations of 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 12.5 mcg | Experimental | 1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM |
|
| NVGH Vi-CRM197 conjugate vaccine 5 mcg | Experimental | 1 dose of 0.5 mL containing 5 mcg of Vi-CRM |
|
| NVGH Vi-CRM197 conjugate vaccine 1.25 mcg | Experimental | 1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM |
|
| Typherix | Active Comparator | 1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVGH Vi-CRM197 12.5 mcg | Biological | 1 dose of 0.5 mL |
| |
| 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 | |
| Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC) | At 28 days after vaccination | |
| Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer | At 28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| 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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Date of first enrollment: 04 OCT 10 Date of last visit: 18 NOV 10
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| ID | Title | Description |
|---|---|---|
| FG000 | NVGH Vi-CRM197 12.5 Mcg | 1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM |
| FG001 | NVGH Vi-CRM197 5.0 Mcg | 1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM |
| FG002 | NVGH Vi-CRM197 1.25 Mcg | 1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM |
| FG003 | Typherix | 1 dose of 0.5 mL containing 25 mcg of Vi-PS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NVGH Vi-CRM197 12.5 Mcg | 1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM |
| BG001 | NVGH Vi-CRM197 5.0 Mcg | 1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM |
| 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 |
|
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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 12.5 Mcg | 1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Audino Podda | 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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| ID | Term |
|---|---|
| C057664 | Vi polysaccharide vaccine, typhoid |
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| NVGH Vi-CRM197 5.0 mcg |
| Biological |
1 dose of 0.5 mL |
|
| NVGH Vi-CRM197 1.25 mcg | Biological | 1 dose of 0.5 mL |
|
| Vi-polysaccharide vaccine | Biological | 1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide |
|
| BG002 | NVGH Vi-CRM197 1.25 Mcg | 1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM |
| BG003 | Typherix | 1 dose of 0.5 mL containing 25 mcg of Vi-PS |
| BG004 | 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 |
|
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM |
| OG003 | Typherix | 1 dose of 0.5 mL containing 25 mcg of Vi-PS |
|
|
| Primary | Number of Subjects Reporting Adverse Events | Posted | Number | participants | During the 28-day period after vaccination |
|
|
|
| Primary | Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC) | Posted | Mean | 95% Confidence Interval | GMC | At 28 days after vaccination |
|
|
|
| Primary | Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer | Posted | Number | 95% Confidence Interval | percentage of subjects | At 28 days after vaccination |
|
|
|
| 0 |
| 21 |
| 19 |
| 21 |
| EG001 | NVGH Vi-CRM197 5.0 Mcg | 1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM | 0 | 22 | 19 | 22 |
| EG002 | NVGH Vi-CRM197 1.25 Mcg | 1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM | 0 | 22 | 22 | 22 |
| EG003 | Typherix | 1 dose of 0.5 mL containing 25 mcg of Vi-PS | 0 | 22 | 19 | 22 |
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| injection site erythema | General disorders | Systematic Assessment |
|
| injection site induration | General disorders | Systematic Assessment |
|
| injection site pain | General disorders | Systematic Assessment |
|
| malaise | General disorders | Systematic Assessment |
|
| nasopharingitis | Infections and infestations | Non-systematic Assessment |
|
| viral URTI | Infections and infestations | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
In the event that no publication of the Study results has been made by NVGH within twelve (12) months of Study database lock and no proposed publication is under discussion by the publication committee, Principal Investigator may publish its own Study results.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |