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

Phase 3

• Conditions: ACYW135 Meningococcal Polysaccharide Vaccine
• Interventions: Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine; Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine

• Registration Number: NCT02869672
• Lead Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-08
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-12
• Last Update Submitted: 2016-08-16
• Study First Posted: 2016-08-17
• Last Update Posted: 2016-08-18
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
age of 7-17 years old, control	Hualan Biology ACYW135 meningococcal polysaccharide vaccine	0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 7-17 years old,experimental	Tiantan Biology ACYW135 meningococcal polysaccharide vaccine	0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 2-6 years old,control	Hualan Biology ACYW135 meningococcal polysaccharide vaccine	0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 2-6 years old,experimental	Tiantan Biology ACYW135 meningococcal polysaccharide vaccine	0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 18-50 years old, experimental	Tiantan Biology ACYW135 meningococcal polysaccharide vaccine	0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 18-50 years old, control	Hualan Biology ACYW135 meningococcal polysaccharide vaccine	0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.

Primary Outcome Measures

Name	Time	Method
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.	28 days	The serum antibody titers will be evaluated at 28 days after vaccination.
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.	28 days	Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.