Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
1 other identifier
interventional
1,200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedAugust 18, 2016
August 1, 2016
5 months
August 12, 2016
August 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (6)
age of 18-50 years old, experimental
EXPERIMENTAL0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 18-50 years old, control
ACTIVE COMPARATOR0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 7-17 years old,experimental
EXPERIMENTAL0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 7-17 years old, control
ACTIVE COMPARATOR0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 2-6 years old,experimental
EXPERIMENTAL0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
age of 2-6 years old,control
ACTIVE COMPARATOR0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given.
Interventions
Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Eligibility Criteria
You may qualify if:
- 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 ℃.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2016
First Posted
August 17, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2016
Last Updated
August 18, 2016
Record last verified: 2016-08