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

ACYW135 Meningococcal Polysaccharide Vaccine Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02869672
• Other study ID #: cycdc2016-5
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: August 12, 2016
• Last updated: August 16, 2016
• Start date: July 2016

Study information

• Verified date: August 2016
• Source: Beijing Chaoyang District Centre for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• ACYW135 Meningococcal Polysaccharide Vaccine

Intervention

Biological:
• Tiantan Biology ACYW135 meningococcal polysaccharide vaccine
Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
• Hualan Biology ACYW135 meningococcal polysaccharide vaccine
Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chaoyang District Centre for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes