Brief Title
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Official Title
A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Brief Summary
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
Secondary Outcome
Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination
Condition
Typhoid Fever
Intervention
Vi-CRM197 vaccine
Study Arms / Comparison Groups
Vi-CRM, Adults
Description: Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
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
200
Start Date
March 2011
Completion Date
June 2012
Primary Completion Date
June 2012
Eligibility Criteria
Main eligibility criteria: - Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment). - Written informed consent will be obtained by the all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial. - Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial. - Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
Gender
All
Ages
6 Weeks - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
NVGH, ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT01229176
Organization ID
H01_02TP
Responsible Party
Sponsor
Study Sponsor
Novartis
Study Sponsor
NVGH, Study Director, Novartis
Verification Date
April 2014