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

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.

Study Overview

• Status: Unknown
• Conditions: ACYW135 Meningococcal Polysaccharide Vaccine
• Intervention / Treatment: Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine; Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: age of 18-50 years old, experimental; 0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.	Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine; Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Active Comparator: age of 18-50 years old, control; 0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.	Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine; Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Experimental: age of 7-17 years old,experimental; 0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.	Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine; Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Active Comparator: age of 7-17 years old, control; 0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.	Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine; Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Experimental: age of 2-6 years old,experimental; 0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.	Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine; Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Active Comparator: age of 2-6 years old,control; 0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.	Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine; Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.	The serum antibody titers will be evaluated at 28 days after vaccination.	28 days
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.	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.	28 days

Collaborators and Investigators

• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Estimate): August 18, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: safety; vaccine; immunogenicity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: cycdc2016-5