Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
December 28, 2021 updated by: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1050
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangxi
-
Quanzhou, Guangxi, China, 530000
- Quanzhou Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 ℃.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High dose Group
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
|
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.
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.
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.
Group 1:3/2/1 dose(s) according to age of subjects.
Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.
|
|
Experimental: Low dose Group
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
|
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.
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.
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.
Group 1:3/2/1 dose(s) according to age of subjects.
Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.
|
|
Other: Adjuvant-free Group
Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
|
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.
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.
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.
Group 1:3/2/1 dose(s) according to age of subjects.
Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.
|
|
Other: Control Group
Haemophilus b Conjugate Vaccine,10μg/dose
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 day after each vaccination
|
|
Antibody positive rate
Time Frame: 30 day after each vaccination
|
Percentage of participants with seroresponse to each vaccination
|
30 day after each vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Du lin, master, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2019
Primary Completion (Actual)
December 7, 2019
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
October 15, 2018
First Submitted That Met QC Criteria
April 28, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 13, 2022
Last Update Submitted That Met QC Criteria
December 28, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Enterobacteriaceae Infections
- Dysentery, Bacillary
- Dysentery
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 201820301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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