Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 35 Months

Launched by BEIJING ZHIFEI LVZHU BIOPHARMACEUTICAL CO., LTD · Jan 28, 2022

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.