Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

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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