NCT04865497CompletedPhase 2
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
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd1 site in 1 country1,050 target enrollmentStarted: January 19, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 1,050
- Locations
- 1
- Primary Endpoint
- incidence of adverse events during 30 days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Months to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 3
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 YearsShigellosisDysenteryNCT05156528Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd21,000
Completed
Phase 1
Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 MonthsDysentery, BacillaryDysenteryNCT03561181Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd180
Completed
Phase 1
PHASE 1 SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19SARS-CoV-2 InfectionNCT04784767U.S. Army Medical Research and Development Command29
Completed
Phase 2
A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of AgeNCT05630846GlaxoSmithKline801
Completed
Phase 1
Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)Pneumococcal InfectionNCT04665050Merck Sharp & Dohme LLC102