DysenteryPhase 2NCT04865497

Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old

A Phase 2 study testing S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine and Haemophilus b Conjugate Vaccine in people with Dysentery and Dysentery, Bacillary, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. Read more about this study

Who is it for?: Ages 3 months to 5 yearsHealthy volunteers can take part
Conditions the study is for: Dysentery, Dysentery, Bacillary
What is being tested?: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine and Haemophilus b Conjugate Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,050 participants
Where: 1 siteChina
Study dates: 19 Jan 2019to 31 Dec 2020
Phase: Phase 2
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 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Health infants and children aged from 3 months to 5 years old.
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.
Subject who haven't immuned with diarrhea vaccination,3-11 months health infants who haven't immuned with Haemophilus b Conjugate vaccination,or had a history of Hib vaccination before the age of 1 but no history of vaccination after 1 year of age,and the interval between the day of the enrollment and the previous dose is more than one month.
Axillary temperature ≤37.0 ℃.

Who cannot join

Febrile illness (temperature ≥ 38°C) in the 3 days or in the acute phase of the disease / active period.
Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
Subject who are allergic to tetanus toxoid.
Allergic history after vaccination.
Immunodeficiency diseases patients (such as perianal abscess suggests that there may be immunodeficiency in infants and young children) who administered with immunosuppressive agents (≥14 days).
Subject who are suffering from serious chronic diseases, cardiovascular disease,liver or kidney disease.

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Subject with congenital malformations, drug allergies, convulsions, epilepsy, history of craniocerebral trauma, encephalopathy and psychosis, or family history.
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(Only applicable to 3-5 months old group).
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

Quanzhou Center for Disease Control and Prevention
Quanzhou, Guangxi, 530000

Other trials in China

About this study

Official title: A Randomized, Blinded, Single-center, Parallel Controlled , Phase Ⅱ Clinical Trial to Evaluate Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged From 3 Months to 5 Years Old

The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.

Conditions: Dysentery, Dysentery, Bacillary
Being tested: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Haemophilus b 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.
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 adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
Haemophilus b Conjugate VaccineBiological
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.

Study groups in NCT04865497
Study group	Role	What they receive
High dose Group	Experimental	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose Receives: Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; Biological: Haemophilus b Conjugate Vaccine
Low dose Group	Experimental	S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose Receives: Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; Biological: Haemophilus b Conjugate Vaccine
Adjuvant-free Group	Other	Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose Receives: Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine; Biological: Haemophilus b Conjugate Vaccine
Control Group	Other	Haemophilus b Conjugate Vaccine,10μg/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.

incidence of adverse events during 30 days
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Measured: 30 day after each vaccination
Antibody positive rate
Percentage of participants with seroresponse to 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.

19 Jan 201931 Dec 2020

First posted29 Apr 2021
Study start19 Jan 2019
Primary completion7 Dec 2019
Study completion31 Dec 2020

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 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,050 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04865497
Sponsor's protocol ID: 201820301
Status last verified: Dec 2021
First submitted: 15 Oct 2018
Last updated: 13 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mo Y, Fang W, Li H, Chen J, Hu X, Wang B, Feng Z, Shi H, He Y, Huang D, Mo Z, Ye Q, Du L. Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China. Vaccines (Basel). 2021 Dec 28;10(1):33. doi: 10.3390/vaccines10010033.
PubMed 35062694

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)
Diarrhea Infectious, Cholera

All Dysentery trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded, Single-center, Parallel Controlled , Phase Ⅱ Clinical Trial to Evaluate Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged From 3 Months to 5 Years Old
ClinicalTrials.gov ID: NCT04865497
Acronym / sponsor ID: 201820301
Conditions: Dysentery, Dysentery, Bacillary
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,050 participants (actual)
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 19 Jan 2019 (actual)
Primary completion: 7 Dec 2019 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 29 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.

The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.

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
High dose Group	Experimental	Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Biological: Haemophilus b Conjugate VaccineS.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Low dose Group	Experimental	Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Biological: Haemophilus b Conjugate VaccineS.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Adjuvant-free Group	Other	Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Biological: Haemophilus b Conjugate VaccineAdjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Control Group	Other	Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineHaemophilus b Conjugate Vaccine,10μg/dose

Who may qualify

Ages: 3 months to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Health infants and children aged from 3 months to 5 years old.
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.
Subject who haven't immuned with diarrhea vaccination,3-11 months health infants who haven't immuned with Haemophilus b Conjugate vaccination,or had a history of Hib vaccination before the age of 1 but no history of vaccination after 1 year of age,and the interval between the day of the enrollment and the previous dose is more than one month.

Key exclusion criteria (11 listed)

Febrile illness (temperature ≥ 38°C) in the 3 days or in the acute phase of the disease / active period.
Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
Subject who are allergic to tetanus toxoid.
Allergic history after vaccination.
Immunodeficiency diseases patients (such as perianal abscess suggests that there may be immunodeficiency in infants and young children) who administered with immunosuppressive agents (≥14 days).

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	Adjuvant-free Group, Control Group, Low 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	Adjuvant-free Group, Control Group, High dose Group
S.Flexneriza-S.Sonnei Bivalent Conjugate VaccineGroup 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.	Biological	Control Group, High dose Group, Low dose Group
Haemophilus b Conjugate VaccineGroup 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.	Biological	Adjuvant-free Group, High dose Group, Low dose Group

Primary outcome

incidence of adverse events during 30 days
Time frame: 30 day after each vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Antibody positive rate
Time frame: 30 day after each vaccination
Percentage of participants with seroresponse to 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 13 Jan 2022.
Results publication: PubMed 35062694Mo Y, Fang W, Li H, Chen J, Hu X, Wang B, Feng Z, Shi H, He Y, Huang D, Mo Z, Ye Q, Du L. Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China. Vaccines (Basel). 2021 Dec 28;10(1):33. doi: 10.3390/vaccines10010033.
Individual participant dataSharing planned: No

Related trials for Dysentery

RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
Recruiting
Evaluating the LGG of on Acute Infectious Diarrhea in Children
Acute Infectious Diarrhoea in Children
Enrolling by invitationPhase 4
A Post-marketing Observational Study of Oral Cholera Vaccine
Diarrhea
Not yet recruitingPhase 1/2
Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants
Shigella Infection
Recruiting
Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)
Diarrhea Infectious, Cholera

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?

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 11 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 13 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

incidence of adverse events during 30 days (time frame: 30 day after each vaccination). 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?

On the ClinicalTrials.gov record for NCT04865497, 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 13 Jan 2022.