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

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, Older infants
Description:  Older Infants (9 to 12 months) receiving 2 doses 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

120

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.
      

Gender

All

Ages

6 Weeks - 59 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Maria Rosario Z Capeding, MD, , 

Location Countries

Philippines

Location Countries

Philippines

Administrative Informations


NCT ID

NCT01437267

Organization ID

H01_05TP


Responsible Party

Sponsor

Study Sponsor

Novartis


Study Sponsor

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


Verification Date

March 2014