DysenteryPhase 3NCT05156528
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
A Phase 3 study testing S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in people with Dysentery and Shigellosis, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysentery, Shigellosis
- What is being tested?
- S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21,000 participants
- Where
- 9 sitesChina
- Study dates
- 11 Dec 2021to 11 Jan 2024
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants and children aged from 3 months to 5 years old;
- The legal representative voluntarily agrees to participate in the study and signed the informed consent form;
- The legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up;
- Subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination;
- Axillary temperature ≤37.0℃;
- According to the medical history, physical examination and the judgment of the researcher, it is determined that the subject is in good physical condition.
Who cannot join
- Previous proven history of bacillary dysentery;
- Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
- Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
- Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
- With pathological jaundice confirmed by existing diagnosis;
- History of thrombocytopenia or other coagulation disorders with definite diagnosis;
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- Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected;
- Received immunoglobulin / blood products treatment within 3 months before vaccination;
- Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia);
- Subjects with the following diseases:
- Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases;
- Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on;
- Severe asthma;
- Systemic rash, dermatophyte, skin suppuration or blister;
- History or family history of convulsion, epilepsy, encephalopathy, mental illness;
- Planning to participate or currently participating in clinical trials of other vaccines or drugs;
- Any situation that the investigator believed may affect the study evaluation.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Yongnian Center for Disease Control and Prevention
Handan, Hebei, 056011
Zhimin Liu, 86-19932006666, liuzhimin199@163.com
- Recruiting
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi, 542899
Jianbiao Li, 86-13635076356, 309551925@qq.com
- Not yet recruiting
Yuanshi Center for Disease Control and Prevention
Huaiyang, Hebei, 051130
Licheng Qi, 86-13582332166, qilicheng@126.com
- Not yet recruiting
Luzhai Center for Disease Control and Prevention
Luzhai, Guangxi, 545699
Baowei Guang, 86-0772-6812646, lzjkxmb@126.com
- Not yet recruiting
Panzhihua Center for Disease Control and Prevention
Panzhihua, Sichuan, 617000
Meixian Liu, 86-18090406818, 449048010@qq.com
- Not yet recruiting
Sanjiang Center for Disease Control and Prevention
Sanjiang, Guangxi, 545500
Xue Yang, 86-13100499521, sjjkxmk@163.com
- Recruiting
Zhongshan Center for Disease Control and Prevention
Zhongshan, Guangxi, 542600
Guide Nong, 86-13321645288, ngd006@163.com
- Not yet recruiting
Zigong Center for Disease Control and Prevention
Zigong, Sichuan, 643000
Qun Li, 86-18990086037, lqzgcdc@163.com
- Not yet recruiting
Fushun Center for Disease Control and Prevention
Zigong, Sichuan, 643299
Yongbin Hu, 86-18990018665, 418299275@qq.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
- Conditions
- Dysentery, Shigellosis
- Being tested
- S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine, Placebo
- 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
Single intramuscular dose contains 10 µg of S. flexneri 2a polysaccharide and S. sonnei polysaccharide respectively.
PlaceboBiological
Single intramuscular dose contains 0.15~0.25 mg of aluminum ion
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine, 0.5ml/dose, 2 doses with an interval of 30 days. Receives: Biological: S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine |
| Placebo group | Placebo comparator | Aluminium phosphate adjuvant, 0.5ml/dose, 2 doses with an interval of 30 days. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate
Evaluate the protective rate for bacillary dysentery
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 posted14 Dec 2021
- Study start11 Dec 2021
- Primary completion11 Jan 2024 (estimated)
- Study completion11 Jan 2024 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156528
- Sponsor's protocol ID
- 2021080C
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
- ClinicalTrials.gov ID
- NCT05156528
- Acronym / sponsor ID
- 2021080C
- Conditions
- Dysentery, Shigellosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21,000 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2021 (actual)
- Primary completion
- 11 Jan 2024 (estimated)
- Study completion
- 11 Jan 2024 (estimated)
- First posted
- 14 Dec 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.
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
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 |
|---|---|---|
| Experimental group | Experimental | Biological: S. Flexneriza-S. Sonnei Bivalent Conjugate VaccineS. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine, 0.5ml/dose, 2 doses with an interval of 30 days. |
| Placebo group | Placebo comparator | Biological: PlaceboAluminium phosphate adjuvant, 0.5ml/dose, 2 doses with an interval of 30 days. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants and children aged from 3 months to 5 years old;
- The legal representative voluntarily agrees to participate in the study and signed the informed consent form;
- The legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up;
- Subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination;
- Axillary temperature ≤37.0℃;
Key exclusion criteria (17 listed)
- Previous proven history of bacillary dysentery;
- Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
- Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
- Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
- With pathological jaundice confirmed by existing diagnosis;
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 VaccineSingle intramuscular dose contains 10 µg of S. flexneri 2a polysaccharide and S. sonnei polysaccharide respectively. | Biological | Experimental group |
| PlaceboSingle intramuscular dose contains 0.15~0.25 mg of aluminum ion | Biological | Placebo group |
Primary outcome
Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate
Time frame: 30 day after each vaccination
Evaluate the protective rate for bacillary dysentery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Lin Du study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
9 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 S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in people with Dysentery and Shigellosis, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 9 sites 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate (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 11 Jan 2022.