Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
Primary Purpose
Dysentery, Dysentery, Bacillary
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
Haemophilus b Conjugate Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Dysentery
Eligibility Criteria
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.
Sites / Locations
- Quanzhou Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Other
Arm Label
High dose Group
Low dose Group
Adjuvant-free Group
Control Group
Arm Description
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Haemophilus b Conjugate Vaccine,10μg/dose
Outcomes
Primary Outcome Measures
incidence of adverse events during 30 days
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Antibody positive rate
Percentage of participants with seroresponse to each vaccination
Secondary Outcome Measures
Full Information
NCT ID
NCT04865497
First Posted
October 15, 2018
Last Updated
December 28, 2021
Sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04865497
Brief Title
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 19, 2019 (Actual)
Primary Completion Date
December 7, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysentery, Dysentery, Bacillary
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1050 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose Group
Arm Type
Experimental
Arm Description
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Arm Title
Low dose Group
Arm Type
Experimental
Arm Description
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Arm Title
Adjuvant-free Group
Arm Type
Other
Arm Description
Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Arm Title
Control Group
Arm Type
Other
Arm Description
Haemophilus b Conjugate Vaccine,10μg/dose
Intervention Type
Biological
Intervention Name(s)
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Haemophilus b Conjugate Vaccine
Intervention Description
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.
Primary Outcome Measure Information:
Title
incidence of adverse events during 30 days
Description
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time Frame
30 day after each vaccination
Title
Antibody positive rate
Description
Percentage of participants with seroresponse to each vaccination
Time Frame
30 day after each vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Du lin, Master
Organizational Affiliation
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Quanzhou Center for Disease Control and Prevention
City
Quanzhou
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35062694
Citation
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.
Results Reference
result
Links:
URL
http://www.mdpi.com/2076-393X/10/1/33
Description
Related Info
Learn more about this trial
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
We'll reach out to this number within 24 hrs