- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123941
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
December 16, 2013 updated by: Novartis
A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wilrijk (Antwerp)
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Antwerp, Wilrijk (Antwerp), Belgium, 2610
- Center for the Evaluation of Vaccination (CEV)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
- Individuals with history of allergy to vaccine components.
- 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.
- Individuals who have previously received any vaccines against typhoid fever.
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine.
- Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
- Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization.
- BMI > 35 kg/m2.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Women who are pregnant or breast-feeding or of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study.
- Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
- Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
- Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NVGH Vi-CRM197 conjugate vaccine
|
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
ACTIVE_COMPARATOR: Vi-polysaccharide vaccine
|
1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Reporting Any Post Immunization Reactions
Time Frame: During the 7-day period after vaccination
|
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
Time Frame: During the 28-day period after vaccination
|
During the 28-day period after vaccination
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: During the 6-month period after vaccination
|
During the 6-month period after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time Frame: At 28 days after vaccination
|
At 28 days after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierre VanDamme, Dr., Center for the Evaluation of Vaccination (CEV)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
May 13, 2010
First Submitted That Met QC Criteria
May 13, 2010
First Posted (ESTIMATE)
May 14, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 17, 2014
Last Update Submitted That Met QC Criteria
December 16, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H01_01TP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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