TyphoidPhase 3NCT04204096
Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)
A Phase 3 study testing Vi-DT (Multi-dose formulation) and Vi-DT (Single dose formulation) in people with Typhoid, run by International Vaccine Institute at 4 sites in Philippines.
Trial summary
This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population. Read more about this study
- Who is it for?
- Ages 6 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid
- What is being tested?
- Vi-DT (Multi-dose formulation) and Vi-DT (Single dose formulation)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 4 sitesPhilippines
- Study dates
- 4 Feb 2020to 29 Jan 2021
- Phase
- Phase 3
- 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 6 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy participants 6 months to 45 years of age at enrollment
- Participants/Parent(s)/LAR who have voluntarily given informed consent/assent
- Participants/Parent(s)/LAR willing to follow the study procedures of the study and available for the entire duration of the study
Who cannot join
- Child with a congenital abnormality
- Participant who has already received meningococcal conjugate vaccine
- Participants concomitantly enrolled or scheduled to be enrolled in another trial
- Known history of immune function disorders including immunodeficiency diseases (Known HIV infection or other immune function disorders)
- Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- Receipt of blood or blood-derived products in the past 3 months
Show all 16Show fewer
- Participant with a previously ascertained or suspected disease caused by S. Typhi (confirmed either clinically, serologically or microbiologically)
- Participant who has had household contact with and/or intimate exposure to an individual with laboratory-confirmed S. Typhi
- Individual who has previously received a typhoid vaccine
- Participant who has received other vaccines from 1 month prior to test vaccination or planned to receive any vaccine within 1 month (except a measles containing vaccine as per government vaccination campaign)
- Known history or allergy to vaccines or other medications
- History of uncontrolled coagulopathy or blood disorders
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
- Any female participant who is lactating, pregnant* or planning for pregnancy during the course of study period
- Participants/Parent(s)/LAR planning to move from the study area before the end of study period
- As per Investigator's medical judgement individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above
Trial locations and contacts
4 sites in 1 country.
Philippines4 sites
Lingga Health Research Center
Calamba, Laguna, 4027
University of the Philippines Manila-National Institutes of Health
Manila, 1000
Putatan Research Center
Muntinlupa, National Capital Region, 1772
Magcase Health Center
San Pablo, Laguna, 4000
About this study
Official title: A Phase III, Multicenter, Observer Blind, Randomized, Controlled Study to Evaluate Immune Equivalence of Multi-dose Formulation Against Single-dose Formulation of Vi-DT Typhoid Conjugate Vaccine and Safety in Healthy Filipino......
This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population.
The study objectives are as follows:
Read more
- Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45 year age stratum), at 4 weeks after a single dose.
- Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion rates of anti-Vi IgG antibody titres of multi dose formulation against single dose formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose.
- Secondary objective 2. Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD formulation/control (Meningococcal Conjugate Vaccine).
There are total 5 scheduled visits as follows:
- Visit 1(D-7 to 0): Screening
- Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
- Visit 3(D7): Safety follow-up
- Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
- V5(D168): Safety follow-up
Read the detailed description
The vaccines will be administered to 1,500 healthy participants of 6 months to 45 years of age and followed up for 24 weeks after the injection for safety. Adult participants (N=500) will be followed up for immunogenicity at 4 weeks and all participants till 24 weeks for safety post single dose of either MD \& SD formulations. 300 healthy participants will be given control vaccine (locally available licensed Meningococcal conjugate vaccine) to check the background safety events. The primary objective is to demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT titer at 4 weeks after a single dose of MD/SD formulation in adults. The secondary objective is to demonstrate the equivalence of immunogenicity in terms of seroconversion rates as measured by anti-Vi IgG ELISA antibody titers, at 4 weeks after a single dose of MD/SD formulation in adults. A descriptive evaluation of safety at 4 and 24 weeks post single dose of (SD/MD/Meningococcal vaccine), will be performed. The Vi-DT vaccine from both MD \& SD formulations will be administered as a single dose of 25 µg/0.5 mL.
Eligible participants enrolled into the study will be randomized into one of the three study groups within each age stratum of 6 months to less than 2 years, 2 to less than 18 years, and 18 to 45 years. Participants will be observed at the study site for 30 minutes after vaccination for safety assessment. Solicited adverse events will be recorded on a diary card during 7 days after vaccination. Unsolicited adverse events will be recorded during the 4 weeks after vaccination. Serious adverse events will be recorded during the entire study period. With the exception of designated study site personnel responsible for vaccine administration, site investigators, study nurse, and those assessing clinical outcomes, and data analysts will be blinded to vaccine allocation until data base lock for the final analysis.
Blood samples will be collected at baseline prior to vaccination and at 4 weeks post vaccination from adults (18-45 years) for immunogenicity assessment
- Conditions
- Typhoid
- Being tested
- Vi-DT (Multi-dose formulation), Vi-DT (Single dose formulation), Control Vaccine
- Keywords
- Typhoid conjugate vaccine, Vi-DT, Safety, Immunogenicity
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-DT (Multi-dose formulation)Biological
Also called Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein
- Manufacturer: SK bioscience Co., Ltd.
- Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (multi dose Vi-DT with preservative 2 PE)
- Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2 to 45 years
- Storage Conditions: +2 to +8°C
Vi-DT (Single dose formulation)Biological
Also called Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein
- Manufacturer: SK bioscience Co., Ltd.
- Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (single dose Vi-DT without any preservative)
- Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2-45 years
- Storage Conditions: +2 to +8°C
Control VaccineBiological
Also called Locally available Meningococcal conjugate vaccine
- For participant ≥ 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered
- For participants 6 months to 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered during the study and the next dose will be provided after the study unblinding at the completion of 6 months follow up of last subject.
| Study group | Role | What they receive |
|---|---|---|
| Vi-DT Multi-dose | Experimental | * 750 participants (6 mo - 45 yrs)
* Dose: 0.5mL, Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein (Vi-DT), manufactured by SK bioscience (Republic of Korea)
* Dosage form: Liquid, 25µg Vi polysaccharide/0.5mL, presented in Type I glass vial (multi-dose formulation Vi-DT contains preservative 2 PE)
* Mode of Administration: Intramuscular injection
* Frequency of administration: Once Receives: Biological: Vi-DT (Multi-dose formulation) |
| Vi-DT Single-dose | Experimental | * 750 participants (6 mo - 45 yrs)
* Dose: 0.5mL, Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein (Vi-DT), manufactured by SK bioscience (Republic of Korea)
* Dosage form: Liquid, 25µg Vi polysaccharide/0.5mL, presented in Type I glass vial (single dose formulation Vi-DT without any preservative)
* Mode of Administration: Intramuscular injection
* Frequency of administration: Once Receives: Biological: Vi-DT (Single dose formulation) |
| Control | Active comparator | * 300 participants (6 mo - 45 yrs)
* Dose: 0.5mL, Locally available Meningococcal conjugate vaccine
* Dosage form: Lyophilized white powder
* Mode of Administration: Intramuscular injection
* Frequency of administration: Once (For participants 6 months to 1 year, one more dose will be provided after the study unblinding) Receives: Biological: Control Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMT) of anti-Vi IgG
If the 95% confidence interval of the ratio of GMT estimate of Vi-DT(MD) over GMT of Vi-DT(SD) is located within the bounds of 0.67to 1.5, then Vi-DT (MD) is equivalent to Vi-DT (SD) in terms of GMT of anti-Vi IgG with significance level of 0.05.
Measured: At 4 weeks (28 days) post vaccination of Vi-DT (MD/SD)
Secondary outcomes (1)
Seroconversion rates of anti-Vi IgG ELISA antibody titres
If the 95% confidence interval of the estimate of difference of seroconversion rate between Vi-DT (MD) and Vi-DT (SD) at 4 weeks (Day 28) is located within the bounds -10% to 10%, then Vi-DT (MD) is equivalent to Vi-DT (SD) in terms of sero-conversion rate, which is defined as 4 fold increase of anti Vi IgG from baseline with significance level of 0.05.
Measured: At 4 weeks (28 days) from baseline (Day 0; before vaccination of Vi-DT (MD/SD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start4 Feb 2020
- Primary completion11 Sep 2020
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants age 6 months to 45 years
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- SK Bioscience Co., Ltd., Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Josefina C Carlos, MD, Principal investigator, University of the East-Ramon Magsaysay Memorial Medical Center Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204096
- Sponsor's protocol ID
- IVI T004
- Status last verified
- Aug 2021
- First submitted
- 17 Dec 2019
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlos JC, Tadesse BT, Borja-Tabora C, Alberto E, Ylade MC, Sil A, Kim DR, Ahn HS, Yang JS, Lee JY, Kim MS, Park J, Kwon SY, Kim H, Yang SY, Ryu JH, Park H, Shin JH, Lee Y, Kim JH, Mojares ZR, Wartel TA, Sahastrabuddhe S. A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age. Lancet Reg Health West Pac. 2022 May 30;24:100484. doi: 10.1016/j.lanwpc.2022.100484. eCollection 2022 Jul.
PubMed 35664443
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Observer Blind, Randomized, Controlled Study to Evaluate Immune Equivalence of Multi-dose Formulation Against Single-dose Formulation of Vi-DT Typhoid Conjugate Vaccine and Safety in Healthy Filipino......
- ClinicalTrials.gov ID
- NCT04204096
- Acronym / sponsor ID
- IVI T004
- Conditions
- Typhoid
- Keywords
- Typhoid conjugate vaccine, Vi-DT, Safety, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- SK Bioscience Co., Ltd., Bill and Melinda Gates Foundation
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- 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 is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population.
The study objectives are as follows:
- Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45 year age stratum), at 4 weeks after a single dose.
- Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion rates of anti-Vi IgG antibody titres of multi dose formulation against single dose formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose.
- Secondary objective 2. Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD formulation/control (Meningococcal Conjugate Vaccine).
There are total 5 scheduled visits as follows:
- Visit 1(D-7 to 0): Screening
- Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
- Visit 3(D7): Safety follow-up
- Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only for subjects 18 years old and above)
- V5(D168): Safety follow-up
Detailed description
The vaccines will be administered to 1,500 healthy participants of 6 months to 45 years of age and followed up for 24 weeks after the injection for safety. Adult participants (N=500) will be followed up for immunogenicity at 4 weeks and all participants till 24 weeks for safety post single dose of either MD \& SD formulations. 300 healthy participants will be given control vaccine (locally available licensed Meningococcal conjugate vaccine) to check the background safety events. The primary objective is to demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT titer at 4 weeks after a single dose of MD/SD formulation in adults. The secondary objective is to demonstrate the equivalence of immunogenicity in terms of seroconversion rates as measured by anti-Vi IgG ELISA antibody titers, at 4 weeks after a single dose of MD/SD formulation in adults. A descriptive evaluation of safety at 4 and 24 weeks post single dose of (SD/MD/Meningococcal vaccine), will be performed. The Vi-DT vaccine from both MD \& SD formulations will be administered as a single dose of 25 µg/0.5 mL.
Eligible participants enrolled into the study will be randomized into one of the three study groups within each age stratum of 6 months to less than 2 years, 2 to less than 18 years, and 18 to 45 years. Participants will be observed at the study site for 30 minutes after vaccination for safety assessment. Solicited adverse events will be recorded on a diary card during 7 days after vaccination. Unsolicited adverse events will be recorded during the 4 weeks after vaccination. Serious adverse events will be recorded during the entire study period. With the exception of designated study site personnel responsible for vaccine administration, site investigators, study nurse, and those assessing clinical outcomes, and data analysts will be blinded to vaccine allocation until data base lock for the final analysis.
Blood samples will be collected at baseline prior to vaccination and at 4 weeks post vaccination from adults (18-45 years) for immunogenicity assessment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants age 6 months to 45 years
| Arm | Type | Receives |
|---|---|---|
| Vi-DT Multi-dose | Experimental | Biological: Vi-DT (Multi-dose formulation)* 750 participants (6 mo - 45 yrs) * Dose: 0.5mL, Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein (Vi-DT), manufactured by SK bioscience (Republic of Korea) * Dosage form: Liquid, 25µg Vi polysaccharide/0.5mL, presented in Type I glass vial (multi-dose formulation Vi-DT contains preservative 2 PE) * Mode of Administration: Intramuscular injection * Frequency of administration: Once |
| Vi-DT Single-dose | Experimental | Biological: Vi-DT (Single dose formulation)* 750 participants (6 mo - 45 yrs) * Dose: 0.5mL, Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein (Vi-DT), manufactured by SK bioscience (Republic of Korea) * Dosage form: Liquid, 25µg Vi polysaccharide/0.5mL, presented in Type I glass vial (single dose formulation Vi-DT without any preservative) * Mode of Administration: Intramuscular injection * Frequency of administration: Once |
| Control | Active comparator | Biological: Control Vaccine* 300 participants (6 mo - 45 yrs) * Dose: 0.5mL, Locally available Meningococcal conjugate vaccine * Dosage form: Lyophilized white powder * Mode of Administration: Intramuscular injection * Frequency of administration: Once (For participants 6 months to 1 year, one more dose will be provided after the study unblinding) |
Who may qualify
- Ages
- 6 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy participants 6 months to 45 years of age at enrollment
- Participants/Parent(s)/LAR who have voluntarily given informed consent/assent
- Participants/Parent(s)/LAR willing to follow the study procedures of the study and available for the entire duration of the study
Key exclusion criteria (16 listed)
- Child with a congenital abnormality
- Participant who has already received meningococcal conjugate vaccine
- Participants concomitantly enrolled or scheduled to be enrolled in another trial
- Known history of immune function disorders including immunodeficiency diseases (Known HIV infection or other immune function disorders)
- Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
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 |
|---|---|---|
| Vi-DT (Multi-dose formulation)Also: Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein* Manufacturer: SK bioscience Co., Ltd. * Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (multi dose Vi-DT with preservative 2 PE) * Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2 to 45 years * Storage Conditions: +2 to +8°C | Biological | Vi-DT Multi-dose |
| Vi-DT (Single dose formulation)Also: Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein* Manufacturer: SK bioscience Co., Ltd. * Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (single dose Vi-DT without any preservative) * Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2-45 years * Storage Conditions: +2 to +8°C | Biological | Vi-DT Single-dose |
| Control VaccineAlso: Locally available Meningococcal conjugate vaccine* For participant ≥ 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered * For participants 6 months to 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered during the study and the next dose will be provided after the study unblinding at the completion of 6 months follow up of last subject. | Biological | Control |
Primary outcome
Geometric Mean Titers (GMT) of anti-Vi IgG
Time frame: At 4 weeks (28 days) post vaccination of Vi-DT (MD/SD)
If the 95% confidence interval of the ratio of GMT estimate of Vi-DT(MD) over GMT of Vi-DT(SD) is located within the bounds of 0.67to 1.5, then Vi-DT (MD) is equivalent to Vi-DT (SD) in terms of GMT of anti-Vi IgG with significance level of 0.05.
1 secondary outcome
Seroconversion rates of anti-Vi IgG ELISA antibody titres
Time frame: At 4 weeks (28 days) from baseline (Day 0; before vaccination of Vi-DT (MD/SD)
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 27 Aug 2021.
- Derived from this study: PubMed 35664443Carlos JC, Tadesse BT, Borja-Tabora C, Alberto E, Ylade MC, Sil A, Kim DR, Ahn HS, Yang JS, Lee JY, Kim MS, Park J, Kwon SY, Kim H, Yang SY, Ryu JH, Park H, Shin JH, Lee Y, Kim JH, Mojares ZR, Wartel TA, Sahastrabuddhe S. A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age. Lancet Reg Health West Pac. 2022 May 30;24:100484. doi: 10.1016/j.lanwpc.2022.100484. eCollection 2022 Jul.
- Individual participant dataSharing planned: No
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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.
Josefina C Carlos, MD principal investigator
University of the East-Ramon Magsaysay Memorial Medical Center Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vi-DT (Multi-dose formulation) and Vi-DT (Single dose formulation) in people with Typhoid, run by International Vaccine Institute at 4 sites in Philippines.
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 3 inclusion and 16 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Philippines. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Geometric Mean Titers (GMT) of anti-Vi IgG (time frame: At 4 weeks (28 days) post vaccination of Vi-DT (MD/SD)). 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 NCT04204096, which also lists 1 linked publication.
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 27 Aug 2021.