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

Phase 3

Completed

• Conditions: Meningitis
• Interventions: Biological: Group T; Biological: Group C

• Registration Number: NCT02003313
• Lead Sponsor: Beijing Minhai Biotechnology Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Primary Completion: 2015-05
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-19
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T	Group T	Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.
Group C	Group C	Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.

Primary Outcome Measures

Name	Time	Method
Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination	28 days after vaccination

Secondary Outcome Measures

Name	Time	Method
to evaluate the adverse reactions after vaccination	within 28 days after vaccination

Trial Locations

Locations (1)

Chaoyang District Centre for Disease Prevention and Control; 🇨🇳 Beijing, China