Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

Beijing Minhai Biotechnology

Status and phase

Completed

Phase 3

Conditions

Meningitis

Treatments

Biological: Group C

Biological: Group T

Study type

Interventional

Funder types

Industry

Identifiers

NCT02003313

2012L02647 (Registry Identifier)

Details and patient eligibility

About

The purpose of this double-blind study is to evaluate the safety, reactogenicity and immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30 years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine.

Enrollment

1,260 patients

Sex

All

Ages

2 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
Healthy permanent residence 2-30 years old.
Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
Axillary temperature ≤37.0 ℃.

Exclusion criteria

History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
Receipt of blood or blood-derived products in the 3 months preceding vaccination.
Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
Receipt of any live virus vaccine in the 15 days preceding vaccination.
Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
Thrombocytopenia.
History of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
Functional or anatomic asplenia.
History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome).
Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.
In pregnancy or lactation or pregnant women during the test plan
Any condition that, in the judgment of investigator, may affect trial assessment.