Status:
COMPLETED
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 35 Months
Lead Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Conditions:
Meningitis, Meningococcal
Eligibility:
All Genders
3-35 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 35 years.
Eligibility Criteria
Inclusion
- People aged 3-35 months;
- Subject who has not been vaccinated with meningococcal group A and C conjugate vaccine, meningococcal group A polysaccharide vaccine and meningococcal group A and C and haemophilus b conjugate vaccine at the aged of 3-11 months, and who have't given boost immunity above 1 year old, and they all meet the physical examination requirements of the project;
- Infants aged 3-11 months should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
- The guardian signs the informed consent form;
- The guardian and his family agree to comply with the requirements of the clinical trial protocol;
- Subject who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
- Axillary body temperature ≤ 37.0 ℃.
Exclusion
- History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
- Have a history of allergy to the vaccine or vaccine ingredients (especially those allergic to tetanus toxoid), or have a history of other serious adverse reactions to the vaccine;
- A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
- Abnormal production process, asphyxia rescue history, or congenital malformation, developmental disorder or serious chronic disease;
- Has serious cardiovascular, liver and kidney diseases or congenital abnormalities and HIV infection;
- Suffer from encephalopathy, uncontrolled epilepsy, convulsion and other progressive nervous system diseases;
- Acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) in the past 3 days;
- Plan to participate or be participating in any other drug clinical research;
- The interval between the first dose of test vaccine and meningococcal group A polysaccharide vaccine is less than 28 days;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT05229536
Start Date
December 21 2018
End Date
November 21 2019
Last Update
February 25 2022
Active Locations (1)
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1
Rongan Center for Disease Control and Prevention
Liuchow, Guangxi, China, 530028