Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine (NCT02003313) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine
China1,260 participantsStarted 2013-11
Plain-language summary
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.
Who can participate
Age range2 Years – 30 Years
SexALL
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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 d…
What they're measuring
1
Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination