Prevention Harmful EffectsPhase 3NCT02164110
To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
A Phase 3 study testing Euvichol and Shanchol in people with Prevention Harmful Effects, run by EuBiologics Co.,Ltd at 1 site in Philippines.
Trial summary
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children. Read more about this study
- Who is it for?
- Ages 1 year to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects
- What is being tested?
- Euvichol and Shanchol
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,632 participants
- Where
- 1 sitePhilippines
- Study dates
- May 2014to Oct 2014
- 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 1 year to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
- Age of 1 ~ 40 years
- An individual who can be followed up during the study period and is capable of complying with the study requirements.
Who cannot join
- History of hypersensitivity reactions to other preventative vaccinations.
- Immune function disorders including immunodeficiency diseases.
- An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
- 38℃ or higher body temperature measured prior to investigational product dosing.
- Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
- Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
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- Other vaccination within 1 week prior to study initiation or planned vaccination during the study.
- Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
- Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
- Pregnant or lactating women.
- An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
- Applicable to the Pivotal study only: history of cholera vaccinations or history of cholera.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
Read the detailed description
A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
- Conditions
- Prevention Harmful Effects
- Being tested
- Euvichol, Shanchol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuvicholBiological
Also called Oral Cholerae Vaccine
- Number of doses and intervals: two doses/Weeks 0 and 2
- Method of administration: oral administration
- Dose of drug to be administered: 1.5 mL/dose
ShancholBiological
Also called Oral cholera vaccine
- Number of doses and intervals: two doses/Weeks 0 and 2
- Method of administration: oral administration
- Dose of drug to be administered: 1.5 mL/dose
| Study group | Role | What they receive |
|---|---|---|
| Euvichol | Experimental | * Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose Receives: Biological: Euvichol |
| Shanchol | Active comparator | * Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose Receives: Biological: Shanchol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline
Measured: 14 days after second doses
Safety
Type and frequency of solicited adverse event type (Day 0 ~ 6), Type and frequency of unsolicited adverse event type (Day 0 ~ Day 28)
Measured: From first shot to 14 days after second dose
Secondary outcomes (4)
Efficacy
- Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O139 antibody, relative to baseline
Measured: 14 days after second doses
Safety
- Change from baseline in vital signs and physical examination
Measured: From first shot to 14 days after second dose
Efficacy
- Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by each anti-V. cholera antibody titer at Week 2 (Visit 3) after the second dose as compared to prior to investigational product dosing (Visit 1).
Measured: 14 days after second doses
Safety
- Change from baseline in laboratory tests (hematologic test, blood chemistry test, urinalysis) to be performed only in subjects who participate in the Pivotal study.
Measured: 14 days after second doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention Harmful EffectsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,632 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario IVI
- Responsible party
- Sponsor
- Investigators
- Roberto A. Espos, MD, Principal investigator, De La Salle University Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164110
- Sponsor's protocol ID
- UBC301
- Status last verified
- Dec 2014
- First submitted
- 27 Apr 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
- ClinicalTrials.gov ID
- NCT02164110
- Acronym / sponsor ID
- UBC301
- Conditions
- Prevention Harmful Effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,632 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario IVI
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Jun 2014 (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.
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
Detailed description
A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euvichol | Experimental | Biological: Euvichol* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose |
| Shanchol | Active comparator | Biological: Shanchol* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose |
Who may qualify
- Ages
- 1 year to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
- Age of 1 ~ 40 years
- An individual who can be followed up during the study period and is capable of complying with the study requirements.
Key exclusion criteria (12 listed)
- History of hypersensitivity reactions to other preventative vaccinations.
- Immune function disorders including immunodeficiency diseases.
- An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
- 38℃ or higher body temperature measured prior to investigational product dosing.
- Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
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 |
|---|---|---|
| EuvicholAlso: Oral Cholerae Vaccine* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose | Biological | Euvichol |
| ShancholAlso: Oral cholera vaccine* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose | Biological | Shanchol |
Primary outcome
Efficacy
Time frame: 14 days after second doses
Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline
Safety
Time frame: From first shot to 14 days after second dose
Type and frequency of solicited adverse event type (Day 0 ~ 6), Type and frequency of unsolicited adverse event type (Day 0 ~ Day 28)
4 secondary outcomes
Efficacy
Time frame: 14 days after second doses
Safety
Time frame: From first shot to 14 days after second dose
Efficacy
Time frame: 14 days after second doses
Safety
Time frame: 14 days after second doses
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 8 Dec 2014.
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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.
Roberto A. Espos, MD principal investigator
De La Salle University Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Euvichol and Shanchol in people with Prevention Harmful Effects, run by EuBiologics Co.,Ltd at 1 site 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 12 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 8 Dec 2014. 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 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?
Efficacy (time frame: 14 days after second doses). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2014.