Prophylaxis for Salmonella enterica serovar Typhi (S. Typhi) disease MedDRA version: 14.0 Level: LLT Classification code 10039446 Term: Salmonella typhi infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Novartis Vaccines Institute for Global Health (NVGH)
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Objectives: To evaluate the safety profile of the NVGH Vi-CRM197 vaccine by measuring rates of local and systemic reactions occurring during 7 days post vaccination and all adverse events occurring for the entire study duration (28 days) in all groups. Immunogenicity Objectives: - To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3, 7 and 28 after vaccination in healthy adults who previously received one dose of either NVGH Vi-CRM197 5.0 µg or the licensed Vi polysaccharide vaccine (Vi-PS) and in healthy adults not previously vaccinated with a typhoid vaccine. - To evaluate the persistence of the anti-Vi antibody response 12 months after vaccination with one dose of either the NVGH Vi-CRM197 or the licensed Vi-PS in the H01_04TP study. ;Secondary Objective: Not applicable;Primary end point(s): Immunogenicity Endpoints - Geometric mean concentrations (GMCs), as determined by ELISA, and geometric mean ratios (GMRs) between post- and pre-vaccination samples. - Seroconversion rate defined as percentage of subjects achieving at least a four-fold rise in ELISA antibody concentration in the post-vaccination blood samples. Safety Endpoints - Numbers and percentage of subjects with solicited local and systemic adverse reactions as well as numbers and percentage of subjects with reported unsolicited adverse events (AEs) and serious adverse events (SAEs). Solicited local reactions include erythema, induration and pain at injection site; solicited systemic reactions include headache, arthralgia, chills, fatigue, malaise, myalgia, and fever (defined as body temperature =38.0°C) ;Timepoint(s) of evaluation of this end point: Immunogenicity Endpoints - GMCs: pre- (day 1) and post-vaccination (days 3, 7, 28) - GMRs: between post- and pre-vaccination samples - Seroconversion rate:post-vaccination (days 3, 7, 28) Safety Endpoints - days 1 to 7 - AEs throughout the study duration (28 d | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactCD&RA
Novartis Vaccines Institute for Global Health (NVGH)
Outcome results
None listed