TyphoidPhase 4NCT00125047
Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood
A Phase 4 study testing Typhoid Vi vaccine and Hepatitis A vaccine in people with Typhoid and Paratyphoid Fever, run by International Vaccine Institute at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid, Paratyphoid Fever
- What is being tested?
- Typhoid Vi vaccine and Hepatitis A vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,231 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2001to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Registered in the project census
- Age: 2-16 years
Who cannot join
- Fever >37.5 degrees Celsius, axillary
- Pregnancy
- Lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi
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 Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.
Read the detailed description
Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence; is given as a single dose; lacks patent protection and requires less strict cold chain requirements. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.
Secondary objectives of this trial are:
- To monitor the adverse events following a routine Vi mass vaccination campaign;
- To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and
- To study typhoid fever risk factors in the population.
A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi.
- Conditions
- Typhoid, Paratyphoid Fever
- Being tested
- Typhoid Vi vaccine, Hepatitis A vaccine
- Keywords
- Salmonellosis, typhoid vaccine, enteric fever
- Medical subject headings
- Typhoid Fever, Paratyphoid Fever, Salmonella Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typhoid Vi vaccineBiological
Also called Typherix
Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
Hepatitis A vaccineBiological
Also called Havrix
single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Typhoid Vi polysaccharide vaccine Receives: Biological: Typhoid Vi vaccine |
| 2 | Active comparator | Inactivated Hepatitis A vaccine Receives: Biological: Hepatitis A vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total protection against S. typhi
Measured: 2 years from zero time
Secondary outcomes (3)
Indirect protection against s. typhi
Measured: two years from zero time
Overall protection against s. typhi
Measured: 2 years from zero time
Adverse event(s) following immunization
Measured: 30 days from vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startOct 2001
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TyphoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Wellcome Trust, University of Western Ontario, Canada, GlaxoSmithKline
- Investigators
- Zulfiqar A Bhutta, MBBS, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125047
- Sponsor's protocol ID
- T-7
- Status last verified
- Aug 2008
- First submitted
- 28 Jul 2005
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ali M, Rasool S, Park JK, Saeed S, Ochiai RL, Nizami Q, Acosta CJ, Bhutta Z. Use of satellite imagery in constructing a household GIS database for health studies in Karachi, Pakistan. Int J Health Geogr. 2004 Sep 28;3(1):20. doi: 10.1186/1476-072X-3-20.
PubMed 15450121Acosta 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.
PubMed 15609776
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi
- ClinicalTrials.gov ID
- NCT00125047
- Acronym / sponsor ID
- T-7
- Conditions
- Typhoid, Paratyphoid Fever
- Keywords
- Salmonellosis, typhoid vaccine, enteric fever
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,231 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Aga Khan University, Wellcome Trust, University of Western Ontario, Canada, GlaxoSmithKline
- Study start
- Oct 2001
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 29 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.
Detailed description
Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence; is given as a single dose; lacks patent protection and requires less strict cold chain requirements. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.
Secondary objectives of this trial are:
- To monitor the adverse events following a routine Vi mass vaccination campaign;
- To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and
- To study typhoid fever risk factors in the population.
A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Typhoid Vi vaccineTyphoid Vi polysaccharide vaccine |
| 2 | Active comparator | Biological: Hepatitis A vaccineInactivated Hepatitis A vaccine |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Registered in the project census
- Age: 2-16 years
Key exclusion criteria (3 listed)
- Fever >37.5 degrees Celsius, axillary
- Pregnancy
- Lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Typhoid Vi vaccineAlso: TypherixSingle 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi. | Biological | 1 |
| Hepatitis A vaccineAlso: Havrixsingle 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen | Biological | 2 |
Primary outcome
Total protection against S. typhi
Time frame: 2 years from zero time
3 secondary outcomes
Indirect protection against s. typhi
Time frame: two years from zero time
Overall protection against s. typhi
Time frame: 2 years from zero time
Adverse event(s) following immunization
Time frame: 30 days from vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2008.
- Background: PubMed 15450121Ali M, Rasool S, Park JK, Saeed S, Ochiai RL, Nizami Q, Acosta CJ, Bhutta Z. Use of satellite imagery in constructing a household GIS database for health studies in Karachi, Pakistan. Int J Health Geogr. 2004 Sep 28;3(1):20. doi: 10.1186/1476-072X-3-20.
- Background: PubMed 15609776Acosta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar A Bhutta, MBBS, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Typhoid Vi vaccine and Hepatitis A vaccine in people with Typhoid and Paratyphoid Fever, run by International Vaccine Institute at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total protection against S. typhi (time frame: 2 years from zero time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2008.