Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old

Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase: Unknown; Phase 3

Conditions: ACYW135 Meningococcal Polysaccharide Vaccine

Treatments: Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine; Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02869672

cycdc2016-5

Details and patient eligibility

About

This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3 group according to their age, receiving the test vaccine and the control vaccine at the proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 2 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• With the subject (or his guardian's) informed consent and signed the informed consent;
• The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
• The Subject or his guardian could comply with the clinical study protocol;
• Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
• Have not been inoculated with other preventive biological products;
• Axillary temperature≤37.0 ℃.

Exclusion criteria

• Children with the history of Neisseria meningitis;
• Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
• Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
• Have been accepted blood products in the past 3 months;
• Have been inoculated with other research drugs or vaccines in the past month;
• Have been inoculated with attenuated live vaccine in the past 14 days;
• Have been inoculated with subunit or inactivated vaccine in the past 7 days;
• Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
• Had fever in the past 3 days (axillary temperature≥38.0℃) ;
• Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
• Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
• Asplenia, functional asplenia and asplenia or splenectomy of any situation;
• Had epilepsy, convulsions, encephalopathy, mental illness or family history;
• Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
• Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
• The female during her pregnant and lactation period or who plan to become pregnant during the trial.
• The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,200 participants in 6 patient groups

age of 18-50 years old, experimental

Experimental group

Description:

0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

Treatment:

Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

age of 18-50 years old, control

Active Comparator group

Description:

0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

Treatment:

Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine

age of 7-17 years old,experimental

Experimental group

Description:

0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

Treatment:

Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

age of 7-17 years old, control

Active Comparator group

Description:

0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

Treatment:

Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine

age of 2-6 years old,experimental

Experimental group

Description:

0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

Treatment:

Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

age of 2-6 years old,control

Active Comparator group

Description:

0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

Treatment:

Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine