Safety, Reactogenicity and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
- Registration Number
- CTRI/2011/12/002233
- Lead Sponsor
- ovartis Vaccine Institute for Global Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
2. Residence in the study area.
3. Males and females of age >=18 to <=45 years
4. Individuals who, after the nature of the study has been explained to them, have given written informed consent according to local regulatory requirements
5. Females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team)
1.Individuals who have a previously ascertained or suspected disease caused by S. Typhi
2.Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi
3.Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion.
4.Non residence in the study area or intent to move out within 3 months
5.Previous inclusion of three family members in the study (i.e., subjects belonging to the same family. Biological father, mother, child, and brothers and sisters may be included up to a maximum of three members from the same family).
6.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 vaccines
7.Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
8.Individuals with history of substance or alcohol abuse within the past 2 years.
9.Women who are pregnant or breast-feeding or of childbearing age who are not willing to participate in family planning consultations (organized by the site study team)
10.Females with history of stillbirth, neonatal loss, or previous infant with anomaly
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Objectives for study part in India: <br/ ><br>â?¢To evaluate the safety profile of Vi-CRM197 compared to that of the licensed Vi polysaccharide vaccine (Typherix GlaxoSmithKline Biologicals) by measuring rates of post immunization reactions and adverse events. <br/ ><br>Timepoint: â?¢Number and Percentage of subjects with local systemic reactions, Adverse Events and SAEs, at 7 and 28 days after each vaccination (reactoginicity and non-solicited safety). <br/ ><br>â?¢Number and percentage of subjects with SAEs during the entire study duration, i.e. as measured at up to 6 months after the last vaciination with the study vaccine. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Immunogenicity Objectives for study part in India: <br/ ><br>â?¢To evaluate the immunogenicity profile of Vi-CRM197 compared to licensed Vi polysaccharide vaccine (Typherix GlaxoSmithKline Biologicals) as measured by enzyme-linked immunosorbent assay (ELISA) <br/ ><br>Timepoint: â?¢Geometric mean concentration (GMCs), before and 28 days after immunization, as determined by ELISA, and applicable geometric mean ratios. <br/ ><br>â?¢Seroconversion rate: percentage of subjects achieving at least a four-fold rise in ELISA antibody concentration 28 days after vaccination, relative to the baseline concentration. <br/ ><br>The above immunogenecity endpoints will be evaluated aslo at 6 months after vaccination for the evaluation of antibody persistence. <br/ ><br>