A Phase 2 interventional study of NVGH Vi-CRM197 12.5 mcg and NVGH Vi-CRM197 5.0 mcg in Typhoid Fever, sponsored by Novartis. Completed at 1 site in Belgium. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-17.
Sponsored by Novartis · Phase 2, Interventional, and Prevention
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
74 studies on the registry are indexed under Typhoid Fever; 10 are open to participants now.
This study's enrollment of 88 is below the median of 149 across 64 interventional studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
Biological: NVGH Vi-CRM197 12.5 mcg
1 dose of 0.5 mL containing 5 mcg of Vi-CRM
Biological: NVGH Vi-CRM197 5.0 mcg
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
Biological: NVGH Vi-CRM197 1.25 mcg
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
Biological: Vi-polysaccharide vaccine
1 dose of 0.5 mL
1 dose of 0.5 mL
1 dose of 0.5 mL
1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide
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
Time frame: During the 7-day period after vaccination
Number of Subjects Reporting Adverse Events
Time frame: During the 28-day period after vaccination
Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)
Time frame: At 28 days after vaccination
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
Time frame: At 28 days after vaccination
Date of first enrollment: 04 OCT 10 Date of last visit: 18 NOV 10
| Milestone | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix |
|---|---|---|---|---|
| Started | 22 | 22 | 22 | 22 |
| Completed | 21 | 22 | 22 | 21 |
| Not completed | 1 | 0 | 0 | 1 |
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue
| participants | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix |
|---|---|---|---|---|
| Number of Subjects Reporting Any Post Immunization Reactions | 18 | 19 | 22 | 16 |
| participants | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix |
|---|---|---|---|---|
| Number of Subjects Reporting Adverse Events | 11 | 16 | 18 | 15 |
| GMC | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix |
|---|---|---|---|---|
| Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC) | 192 (129 to 286) | 111 (75 to 165) | 63 (41 to 95) | 37 (24 to 55) |
| percentage of subjects | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix |
|---|---|---|---|---|
| Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer | 100 (84 to 100) | 100 (84 to 100) | 95 (74 to 100) | 95 (75 to 100) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NVGH Vi-CRM197 12.5 Mcg | — | 0/21 (0%) | 19/21 (90.5%) |
| NVGH Vi-CRM197 5.0 Mcg | — | 0/22 (0%) | 19/22 (86.4%) |
| NVGH Vi-CRM197 1.25 Mcg | — | 0/22 (0%) | 22/22 (100%) |
| Typherix | — | 0/22 (0%) | 19/22 (86.4%) |
| Event | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix |
|---|---|---|---|---|
| injection site painGeneral disorders | 17/21 | 16/22 | 21/22 | 9/22 |
| headacheNervous system disorders | 11/21 | 11/22 | 12/22 | 10/22 |
| FatigueGeneral disorders | 7/21 | 11/22 | 8/22 | 7/22 |
| nasopharingitisInfections and infestations | 4/21 | 9/22 | 5/22 | 5/22 |
| myalgiaMusculoskeletal and connective tissue disorders | 5/21 | 4/22 | 4/22 | 3/22 |
| diarrhoeaGastrointestinal disorders | 1/21 | 3/22 | 5/22 | 1/22 |
| malaiseGeneral disorders | 4/21 | 4/22 | 5/22 | 4/22 |
| nauseaGastrointestinal disorders | 0/21 | 4/22 | 2/22 | 0/22 |
| injection site indurationGeneral disorders | 3/21 | 4/22 | 3/22 | 2/22 |
| injection site erythemaGeneral disorders | 3/21 | 2/22 | 2/22 | 0/22 |
| Age, Categorical(Participants) | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 22 | 22 | 22 | 88 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix | Total |
|---|---|---|---|---|---|
| Mean | 24.3 ± 4.9 | 24.3 ± 5.4 | 24.0 ± 5.7 | 23.8 ± 5.5 | 24.1 ± 5.3 |
| Sex: Female, Male(Participants) | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix | Total |
|---|---|---|---|---|---|
| Female | 14 | 15 | 17 | 15 | 61 |
| Male | 8 | 7 | 5 | 7 | 27 |
| Region of Enrollment(participants) | NVGH Vi-CRM197 12.5 Mcg | NVGH Vi-CRM197 5.0 Mcg | NVGH Vi-CRM197 1.25 Mcg | Typherix | Total |
|---|---|---|---|---|---|
| Belgium | 22 | 22 | 22 | 22 | 88 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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