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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02867319
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Beijing Chaoyang District Centre for Disease Control and Prevention

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Meningococcal Biological: A dose of ACYW135 meningococcal polysaccharide vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2016
Actual Primary Completion Date : July 2016

Arm Intervention/treatment
Experimental: age of 18-50 years old Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.

Experimental: age of 7-17 years old Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.

Experimental: age of 2-6 years old Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.




Primary Outcome Measures :
  1. The rate of adverse reactions of ACYW135 meningococcal polysaccharide vaccine [ Time Frame: 28 days ]
    Adverse reactions associated with vaccine will be observed in subjects after each 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



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Ages Eligible for Study:   2 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Beijing Chaoyang District Centre for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02867319     History of Changes
Other Study ID Numbers: cycdc2016-3
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Beijing Chaoyang District Centre for Disease Control and Prevention:
safety
vaccine

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs