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

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Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase

Completed
Phase 1

Conditions

Meningococcal

Treatments

Biological: A dose of ACYW135 meningococcal polysaccharide vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT02867319
cycdc2016-3

Details and patient eligibility

About

This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and active surveillance.

Enrollment

60 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

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 3 patient groups

age of 18-50 years old
Experimental group
Treatment:
Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
age of 7-17 years old
Experimental group
Treatment:
Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
age of 2-6 years old
Experimental group
Treatment:
Biological: A dose of ACYW135 meningococcal polysaccharide vaccine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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