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

Learn more about:
Related Clinical Trial
Transcriptomic Responses for the Identification of Pathogens Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants Commercial Typhoid Tests Validation Trial Commercial Typhoid Tests Validation WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial) Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old) Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Safety and Immunogenicity of Typhax, a Typhoid Vaccine Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III) Investigating Enteric Fever – Salmonella Typhi and Paratyphi Challenge Study Induction of Gut Permeability by an Oral Vaccine Studies of Immune Responses to Orally Administered Vaccines in Developing Country Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age Salmonella Typhi Vi O-Acetyl Pectin-rEPA Conjugate Vaccine Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants Typhoid Fever: Combined vs. Single Antibiotic Therapy Vaccines Against Salmonella Typhi Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults CVD 909 Vi Prime Boost Study Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso Understanding Typhoid Disease After Vaccination Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood Global Genomic and Proteomic Profiling of African Children With Typhoid Fever

Brief Title

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

Official Title

A Phase 2, Randomized, Observer-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the Novartis Vaccines Institute for Global Health (NVGH) Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age

Brief 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
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Subjects Reporting Any Post Immunization Reactions


Condition

Typhoid Fever

Intervention

NVGH Vi-CRM197 12.5 mcg

Study Arms / Comparison Groups

 NVGH Vi-CRM197 conjugate vaccine 12.5 mcg
Description:  1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

88

Start Date

October 2010

Completion Date

November 2010

Primary Completion Date

November 2010

Eligibility Criteria

        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:

          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.
      

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01193907

Organization ID

H01_04TP

Secondary IDs

2010-021874-12

Responsible Party

Sponsor

Study Sponsor

Novartis


Study Sponsor

, , 


Verification Date

December 2013