Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
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
1 other identifier
interventional
1,050
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2018
CompletedStudy Start
First participant enrolled
January 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedJanuary 13, 2022
December 1, 2021
11 months
October 15, 2018
December 28, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
incidence of adverse events during 30 days
Occurrence of adverse events during a 30 day follow-up period after each vaccination
30 day after each vaccination
Antibody positive rate
Percentage of participants with seroresponse to each vaccination
30 day after each vaccination
Study Arms (4)
High dose Group
EXPERIMENTALS.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Low dose Group
EXPERIMENTALS.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
Adjuvant-free Group
OTHERAdjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
Control Group
OTHERHaemophilus b Conjugate Vaccine,10μg/dose
Interventions
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 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.
Eligibility Criteria
You may qualify if:
- 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 ℃.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quanzhou Center for Disease Control and Prevention
Quanzhou, Guangxi, 530000, China
Related Publications (1)
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.
PMID: 35062694RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Du lin, Master
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2018
First Posted
April 29, 2021
Study Start
January 19, 2019
Primary Completion
December 7, 2019
Study Completion
December 31, 2020
Last Updated
January 13, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share