CompletedPhase 1

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

Belgium50 participantsStarted 2010-05

Plain-language summary

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.

Who can participate

Age range18 Years – 40 Years

SexALL

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Inclusion criteria

✓. Males and females of age ≥18 to ≤40 years.
✓. Individuals who, after the nature of the study has been explained to them, have given written consent according to local regulatory requirements.
✓. Individuals in good health as determined by the outcome of medical history, physical examination, hematological / hematochemical blood tests and urinalysis and clinical judgment of the investigator.
✓. If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration

Exclusion criteria

✕. 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.
✕. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
✕. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
✕. 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.
✕. 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.
✕. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
✕. Individuals with any serious chronic or progressive disease according to judgment of the investigator.
✕. Individuals who have any malignancy or lymphoproliferative disorder.

What they're measuring

Number of Subjects Reporting Any Post Immunization Reactions

Timeframe: During the 7-day period after vaccination

Number of Subjects Reporting Adverse Events

Timeframe: During the 28-day period after vaccination

Number of Subjects Reporting Serious Adverse Events (SAEs)

Timeframe: During the 6-month period after vaccination

Trial details

NCT IDNCT01123941

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-06

Results submitted2012-02-29

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