DysenteryPhase 1NCT03561181
Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
A Phase 1 study testing S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in people with Dysentery and Dysentery, Bacillary, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Dysentery, Dysentery, Bacillary
- What is being tested?
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2017to 8 Feb 2018
- Phase
- Phase 1
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 3 months old and above healthy people.
- Subject or legal representative who consent and has signed written informed consent.
- Subject and parent/guardian who is able to comply with all study procedures.
- Subject who did't receive blood products within 30 days ,immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- Axillary temperature ≤37.0 ℃.
Who cannot join
- Febrile illness (temperature ≥ 38°C) in the 3 days.
- Subject who are allergic to tetanus toxoid.
- Allergic history after vaccination.
- Immunodeficiency diseases patients who administered with immunosuppressive agents.
- In pregnancy or lactation or pregnant women.
- Subject who are suffering from serious chronic diseases, infectious diseases, active infection, cardiovascular disease,liver or kidney disease.
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- Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
- History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
- Subject who diagnosis of thrombocytopenia or other history of coagulopathy may cause intramuscular contraindication.
- Children with abnormal labor（pregnancy week<37w,>42w）,birth weight (<2500g,>4000g), asphyxia rescue history,congenital malformations or developmental disorders(Only applicable to 3-5 months old group)
- Blood routine, blood chemistry and urinalysis laboratory collection abnormalities and the severity of grade 2 and above before immunization.
- Subject who plan to participate in or is in any other drug clinical trial.
- Any condition that, in the judgment of investigator, may affect trial assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Yizhou Center for Disease Control and Prevention
Yizhou, Guangxi, 546300
About this study
Official title: A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
- Conditions
- Dysentery, Dysentery, Bacillary
- Being tested
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
- Medical subject headings
- Dysentery, Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineBiological
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineBiological
Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
| Study group | Role | What they receive |
|---|---|---|
| High dose Group | Experimental | Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose Receives: Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine |
| low dose Group | Experimental | Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose Receives: Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Measured: 30 day after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start18 Jul 2017
- Primary completion28 Jan 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysenteryStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Du lin, Master, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561181
- Sponsor's protocol ID
- 201619306
- Status last verified
- Oct 2018
- First submitted
- 7 Jun 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
- ClinicalTrials.gov ID
- NCT03561181
- Acronym / sponsor ID
- 201619306
- Conditions
- Dysentery, Dysentery, Bacillary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 19 Jun 2018 (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.
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Group | Experimental | Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineReceived Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose |
| low dose Group | Experimental | Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineReceived Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 3 months old and above healthy people.
- Subject or legal representative who consent and has signed written informed consent.
- Subject and parent/guardian who is able to comply with all study procedures.
- Subject who did't receive blood products within 30 days ,immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- Axillary temperature ≤37.0 ℃.
Key exclusion criteria (13 listed)
- Febrile illness (temperature ≥ 38°C) in the 3 days.
- Subject who are allergic to tetanus toxoid.
- Allergic history after vaccination.
- Immunodeficiency diseases patients who administered with immunosuppressive agents.
- In pregnancy or lactation or pregnant women.
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 |
|---|---|---|
| S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineGroup 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine. | Biological | High dose Group |
| S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineGroup 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine. | Biological | low dose Group |
Primary outcome
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time frame: 30 day after each 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 17 Oct 2018.
- 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.
Du lin, Master study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in people with Dysentery and Dysentery, Bacillary, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
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 13 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 17 Oct 2018. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Occurrence of adverse events during a 30 day follow-up period after each vaccination (time frame: 30 day after each vaccination). 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 17 Oct 2018.