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

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Brief Title

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

Official Title

A Phase 2, Randomized, Controlled, Observer Blind, Single Center Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in 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 children and infants from various age groups in the Philippines where Typhoid
      Fever is highly endemic and an efficacious vaccine against this disease is very much needed.

Study Phase

Phase 2

Study Type


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


Typhoid Fever


Vi-CRM197 vaccine

Study Arms / Comparison Groups

 Vi-CRM, Older infants
Description:  Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine


* 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

August 2012

Primary Completion Date

August 2012

Eligibility Criteria

        Inclusion criteria:

          -  Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59
             months of age at enrollment), 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 parents/ guardians before enrollment
             into the trial.

          -  Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since
             birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due
             at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.




6 Weeks - 59 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Maria Rosario Z Capeding, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor


Study Sponsor

Maria Rosario Z Capeding, MD, Principal Investigator, Research Institute for Tropical Medicine (RITM)

Verification Date

March 2014