Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults

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Brief Title

Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults

Official Title

A Phase 2, Open-label, Single-center, Extension Study to Evaluate the Booster Response Induced by Vi-CRM197 After Priming With Either Vi-CRM197 or Typherix Administered in Adult Subjects in H01_04TP Study (NCT01193907)

Brief Summary

      The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi
      antibody response following secondary vaccination with the Novartis Vaccines Institute for
      Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either
      the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and
      the immunogenicity and the kinetics of the anti-Vi antibody response following primary
      vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.

Study Phase

Phase 2

Study Type


Primary Outcome

Anti-Vi ELISA Geometric Mean Concentration (GMC)

Secondary Outcome

 Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction


Typhoid Fever



Study Arms / Comparison Groups

Description:  One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study


* 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


Estimated Enrollment


Start Date

October 2011

Completion Date

December 2011

Primary Completion Date

December 2011

Eligibility Criteria

        Inclusion criteria

        All Subjects:

          1. Males and females of age ≥18 to ≤42 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. 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.

             H01_04TP subjects only:

          5. Individuals who previously participated in the H01_04TP study and were vaccinated with
             either NVGH Vi-CRM197 (5μg) or with the licensed Vi-PS.

          6. Individuals who have received no Vi vaccination subsequent to the one received in the
             H01_04TP study.

        Inclusion criteria

        All subjects:

          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, 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 received any 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

         12. Individuals who have received blood, blood products and/or plasma derivatives
             including parenteral immunoglobulin preparations in the past 12 weeks.

         13. Individuals who are part of study personnel or close family members to the personnel
             conducting this study.

         14. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended
             study immunization.

         15. BMI > 35 kg/m2.

         16. Individuals with history of substance or alcohol abuse within the past 2 years.

         17. 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.

         18. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.

         19. Individuals who have a previously ascertained or suspected disease caused by S. Typhi.

         20. Individuals who have had household contact with/and or intimate exposure to an
             individual with laboratory confirmed S. Typhi.

         21. Any condition which, in the opinion of the investigator may interfere with the
             evaluation of the study objectives.

             Naïve subjects only:

         22. Individuals who have previously received any vaccine against typhoid fever (either
             oral live attenuated or injectable vaccines)




18 Years - 42 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Pierre Van Damme, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor


Study Sponsor

Pierre Van Damme, MD, Principal Investigator, Universiteit Antwerpen

Verification Date

February 2014