Clinical trial NCT02869672: Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ACYW135 Meningococcal Polysaccharide Vaccine
Keywords: safety
immunogenicity
vaccine
Lead sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


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.

Primary outcomes:
measure: Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
timeFrame: 28 days
measure: Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: