Typhoid FeverPhase 2/3NCT04830371
Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
A Phase 2/3 study testing EuTCV (Vi-CRM Typhoid conjugate vaccine) and Typbar-TCV in people with Typhoid Fever, run by EuBiologics Co.,Ltd at 2 sites in Philippines.
Trial summary
This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years. 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 Fever
- What is being tested?
- EuTCV (Vi-CRM Typhoid conjugate vaccine) and Typbar-TCV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 2 sitesPhilippines
- Study dates
- 7 Sep 2020to 1 Aug 2021
- Phase
- Phase 2/3
- 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 and ≤45 years of age at enrolment
- Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial
- Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
- Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
- Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination.
Who cannot join
- Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
- Participants concomitantly enrolled or scheduled to be enrolled in another trial
- Children and infants with a congenital abnormality
- Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- 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 trial objectives
- History of alcohol or substance abuse
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
De La Salle Medical and Health Sciences Institute
Cavite
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City
About this study
Official title: A Phase II/III, Multicenter, Observer-Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.
- Conditions
- Typhoid Fever
- Being tested
- EuTCV (Vi-CRM Typhoid conjugate vaccine), Typbar-TCV
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuTCV (Vi-CRM Typhoid conjugate vaccine)Biological
Single dose, Intramuscular administration
Typbar-TCVBiological
Single dose, Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Vi-CRM197, Batch #1) | Experimental | Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0. Receives: Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine) |
| Arm A (Vi-CRM197, Batch #2) | Experimental | Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0. Receives: Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine) |
| Arm A (Vi-CRM197, Batch #3) | Experimental | Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0. Receives: Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine) |
| Arm D (Typbar-TCV) | Active comparator | Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0. Receives: Biological: Typbar-TCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
Measured: 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline
Proportion of Solicited local and systemic AEs
Measured: 7 days after vaccination
Proportion of unsolicited AEs
Measured: within 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start7 Sep 2020
- Primary completion18 Mar 2021
- Study completion1 Aug 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 Typhoid FeverStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830371
- Sponsor's protocol ID
- EuVCT_TCV301
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ok Baik Y, Lee Y, Lee C, Kyung Kim S, Park J, Sun M, Jung D, Young Jang J, Jun Yong T, Woo Park J, Jeong S, Lim S, Hyun Han S, Keun Choi S. A Phase II/III, Multicenter, Observer-blinded, Randomized, Non-inferiority and Safety, study of typhoid conjugate vaccine (EuTCV) compared to Typbar-TCV(R) in healthy 6 Months-45 years aged participants. Vaccine. 2023 Mar 3;41(10):1753-1759. doi: 10.1016/j.vaccine.2022.12.007. Epub 2023 Feb 9.
PubMed 36774331
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Multicenter, Observer-Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
- ClinicalTrials.gov ID
- NCT04830371
- Acronym / sponsor ID
- EuVCT_TCV301
- Conditions
- Typhoid Fever
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 5 Apr 2021 (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 an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A (Vi-CRM197, Batch #1) | Experimental | Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0. |
| Arm A (Vi-CRM197, Batch #2) | Experimental | Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0. |
| Arm A (Vi-CRM197, Batch #3) | Experimental | Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0. |
| Arm D (Typbar-TCV) | Active comparator | Biological: Typbar-TCVSingle dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0. |
Who may qualify
- Ages
- 6 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy participants ≥6 months and ≤45 years of age at enrolment
- Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial
- Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
- Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
- Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination.
Key exclusion criteria (8 listed)
- Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
- Participants concomitantly enrolled or scheduled to be enrolled in another trial
- Children and infants with a congenital abnormality
- Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
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 |
|---|---|---|
| EuTCV (Vi-CRM Typhoid conjugate vaccine)Single dose, Intramuscular administration | Biological | Arm A (Vi-CRM197, Batch #1), Arm A (Vi-CRM197, Batch #2), Arm A (Vi-CRM197, Batch #3) |
| Typbar-TCVSingle dose, Intramuscular administration | Biological | Arm D (Typbar-TCV) |
Primary outcome
Seroconversion rate
Time frame: 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline
Proportion of Solicited local and systemic AEs
Time frame: 7 days after vaccination
Proportion of unsolicited AEs
Time frame: within 28 days after 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 7 Oct 2021.
- Derived from this study: PubMed 36774331Ok Baik Y, Lee Y, Lee C, Kyung Kim S, Park J, Sun M, Jung D, Young Jang J, Jun Yong T, Woo Park J, Jeong S, Lim S, Hyun Han S, Keun Choi S. A Phase II/III, Multicenter, Observer-blinded, Randomized, Non-inferiority and Safety, study of typhoid conjugate vaccine (EuTCV) compared to Typbar-TCV(R) in healthy 6 Months-45 years aged participants. Vaccine. 2023 Mar 3;41(10):1753-1759. doi: 10.1016/j.vaccine.2022.12.007. Epub 2023 Feb 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EuTCV (Vi-CRM Typhoid conjugate vaccine) and Typbar-TCV in people with Typhoid Fever, run by EuBiologics Co.,Ltd at 2 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 5 inclusion and 8 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Seroconversion rate (time frame: 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline). The study lists 3 primary outcomes in all. 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 NCT04830371, 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 7 Oct 2021.