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

NCT ID: NCT02869672

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31

Brief Summary

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.

Conditions

ACYW135 Meningococcal Polysaccharide Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

age of 18-50 years old, experimental

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

Group Type: EXPERIMENTAL

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

age of 18-50 years old, control

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

Group Type: ACTIVE_COMPARATOR

Hualan Biology ACYW135 meningococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

age of 7-17 years old,experimental

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

Group Type: EXPERIMENTAL

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

age of 7-17 years old, control

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

Group Type: ACTIVE_COMPARATOR

Hualan Biology ACYW135 meningococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

age of 2-6 years old,experimental

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

Group Type: EXPERIMENTAL

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

age of 2-6 years old,control

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

Group Type: ACTIVE_COMPARATOR

Hualan Biology ACYW135 meningococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

Interventions

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Hualan Biology ACYW135 meningococcal polysaccharide vaccine

Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Chaoyang District Centre for Disease Control and Prevention

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

cycdc2016-5

Identifier Type: -

Identifier Source: org_study_id