NCT00125008

Brief Summary

This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Kolkata, India. The cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37,673

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

Enrollment Period

4.7 years

First QC Date

July 28, 2005

Last Update Submit

August 25, 2008

Conditions

TyphoidParatyphoid Fever

Keywords

SalmonellaTyphoid vaccineenteric fever

Outcome Measures

Primary Outcomes (1)

  • Total protection against S. typhi

    2 years from zero time

Secondary Outcomes (4)

  • Indirect protection against S. typhi

    2 years from zero time

  • Overall protection against S. typhi

    2 years from zero time

  • Total protection against S. paratyphi

    2 years from zero time

  • Adverse event(s) following immunization

    30 days from vaccination

Study Arms (2)

1

EXPERIMENTAL

Typhoid Vi vaccine

Biological: Typhoid Vi vaccine

2

ACTIVE COMPARATOR

Hepatitis A vaccine

Biological: Hepatitis A vaccine

Interventions

Typhoid Vi vaccineBIOLOGICAL

single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)

Also known as: Typherix
1
Hepatitis A vaccineBIOLOGICAL

720 EL.U. of inactivated hepatitis A viral antigen for children 1440 EL.U. of inactivated hepatitis A viral antigen for adults

Also known as: Havrix
2

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Registered in the project census
  • Age \>=2 years
  • Provide informed consent to receive vaccine

You may not qualify if:

  • Fever (\>37.5 degrees Celsius)
  • Pregnancy
  • Lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

Location

Related Publications (3)

  • Acosta CJ, Galindo CM, Ochiai RL, Danovaro-Holliday MC, Page AL, Thiem VD, Park JK, Park E, Koo H, Wang XY, Abu-Elyazeed R, Ali M, Albert MJ, Ivanoff B, Pang T, Xu ZY, Clemens JD. The role of epidemiology in the introduction of vi polysaccharide typhoid fever vaccines in Asia. J Health Popul Nutr. 2004 Sep;22(3):240-5.

    PMID: 15609776BACKGROUND

  • Dutta S, Sur D, Manna B, Bhattacharya SK, Deen JL, Clemens JD. Rollback of Salmonella enterica serotype Typhi resistance to chloramphenicol and other antimicrobials in Kolkata, India. Antimicrob Agents Chemother. 2005 Apr;49(4):1662-3. doi: 10.1128/AAC.49.4.1662-1663.2005. No abstract available.

    PMID: 15793167BACKGROUND

  • Sur D, Ochiai RL, Bhattacharya SK, Ganguly NK, Ali M, Manna B, Dutta S, Donner A, Kanungo S, Park JK, Puri MK, Kim DR, Dutta D, Bhaduri B, Acosta CJ, Clemens JD. A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. N Engl J Med. 2009 Jul 23;361(4):335-44. doi: 10.1056/NEJMoa0807521.

    PMID: 19625715DERIVED

MeSH Terms

Conditions

Typhoid FeverParatyphoid Fever

Interventions

Vi polysaccharide vaccine, typhoidHepatitis A Vaccines

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Sujit K Bhatttacharya, MD

    National Institute of Cholera and Enteric Diseases, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2005

First Posted

July 29, 2005

Study Start

May 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

August 26, 2008

Record last verified: 2008-08

Locations

IN(1)