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CompletedNCT01193907Updated Jan 17, 2014Results posted

Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)

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

Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Typhoid Fever

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Keywords

  • Typhoid fever
  • Glycoconjugate vaccine
  • Vi polysaccharide
  • Immunogenicity
03

In context

Typhoid Fever

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males and females of age ≥18 to ≤40 years.
  2. Individuals who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
  3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
  4. Individuals with negative urine screening tests for drug addition (Opiate, Cocaine, Amph/Metamphetamine, Cannabinoides )
  5. If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration.

Exclusion criteria

Exclusion Criteria:

  1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
  2. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
  3. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
  4. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
  5. Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
  6. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  7. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
  8. Individuals who have any malignancy or lymphoproliferative disorder.
  9. Individuals with history of allergy to vaccine components.
  10. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
  11. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines).
  12. Individuals who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine.
  13. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
  14. Individuals who are part of study personnel or close family members to the personnel conducting this study.
  15. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization.
  16. BMI > 35 kg/m2.
  17. Individuals with history of substance or alcohol abuse within the past 2 years.
  18. Women who are pregnant or breast-feeding or of childbearing age who have not used any birth control measure one month prior to study start or do not plan to use acceptable birth control measures, for the duration of the study.
  19. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
  20. Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
  21. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
  22. Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    NVGH Vi-CRM197 conjugate vaccine 12.5 mcg

    1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM

    Biological: NVGH Vi-CRM197 12.5 mcg

  • Experimental
    NVGH Vi-CRM197 conjugate vaccine 5 mcg

    1 dose of 0.5 mL containing 5 mcg of Vi-CRM

    Biological: NVGH Vi-CRM197 5.0 mcg

  • Experimental
    NVGH Vi-CRM197 conjugate vaccine 1.25 mcg

    1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM

    Biological: NVGH Vi-CRM197 1.25 mcg

  • Active comparator
    Typherix

    1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide

    Biological: Vi-polysaccharide vaccine

Interventions

  • BiologicalNVGH Vi-CRM197 12.5 mcg

    1 dose of 0.5 mL

  • BiologicalNVGH Vi-CRM197 5.0 mcg

    1 dose of 0.5 mL

  • BiologicalNVGH Vi-CRM197 1.25 mcg

    1 dose of 0.5 mL

  • BiologicalVi-polysaccharide vaccine

    1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide

06

What researchers measure

Primary outcomes

  1. 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

  2. Number of Subjects Reporting Adverse Events

    Time frame: During the 28-day period after vaccination

  3. Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)

    Time frame: At 28 days after vaccination

  4. Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer

    Time frame: At 28 days after vaccination

07

Results

Posted Apr 3, 2012

Participant flow

Date of first enrollment: 04 OCT 10 Date of last visit: 18 NOV 10

Participant flow — Overall Study
MilestoneNVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherix
Started22222222
Completed21222221
Not completed1001

Outcome measures

PrimaryNumber 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
Reported as:
Number · participants
Number of Subjects Reporting Any Post Immunization Reactions
participantsNVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherix
Number of Subjects Reporting Any Post Immunization Reactions18192216
PrimaryNumber of Subjects Reporting Adverse Events
Time frame:
During the 28-day period after vaccination
Reported as:
Number · participants
Number of Subjects Reporting Adverse Events
participantsNVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherix
Number of Subjects Reporting Adverse Events11161815
PrimaryAnti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)
Time frame:
At 28 days after vaccination
Reported as:
Mean · GMC
Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)
GMCNVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherix
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)
PrimaryPercentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
Time frame:
At 28 days after vaccination
Reported as:
Number · percentage of subjects
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
percentage of subjectsNVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherix
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer100 (84 to 100)100 (84 to 100)95 (74 to 100)95 (75 to 100)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventNVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherix
injection site painGeneral disorders17/2116/2221/229/22
headacheNervous system disorders11/2111/2212/2210/22
FatigueGeneral disorders7/2111/228/227/22
nasopharingitisInfections and infestations4/219/225/225/22
myalgiaMusculoskeletal and connective tissue disorders5/214/224/223/22
diarrhoeaGastrointestinal disorders1/213/225/221/22
malaiseGeneral disorders4/214/225/224/22
nauseaGastrointestinal disorders0/214/222/220/22
injection site indurationGeneral disorders3/214/223/222/22
injection site erythemaGeneral disorders3/212/222/220/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)NVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherixTotal
<=18 years00000
Between 18 and 65 years2222222288
>=65 years00000
Age, Continuous
Age, Continuous(years)NVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherixTotal
Mean24.3 ± 4.924.3 ± 5.424.0 ± 5.723.8 ± 5.524.1 ± 5.3
Sex: Female, Male
Sex: Female, Male(Participants)NVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherixTotal
Female1415171561
Male875727
Region of Enrollment
Region of Enrollment(participants)NVGH Vi-CRM197 12.5 McgNVGH Vi-CRM197 5.0 McgNVGH Vi-CRM197 1.25 McgTypherixTotal
Belgium2222222288
08

Study locations

1 site
  • Center for the Evaluation of Vaccination (CEV)
    Antwerp, Wilrijk (Antwerp) 2610, Belgium
09

References and documents

Publications

  • 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. PubMed 21980445 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01193907
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Sep 2, 2010
Start date
Oct 2010
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Apr 3, 2012
Last update
Jan 17, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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