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

NCT ID: NCT02003313

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group T

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

Group Type: EXPERIMENTAL

Group T

Intervention Type: BIOLOGICAL

0.5ml, Intramuscular

Group C

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

Group Type: ACTIVE_COMPARATOR

Group C

Intervention Type: BIOLOGICAL

0.5ml, Intramuscular

Interventions

Group T

0.5ml, Intramuscular

Intervention Type: BIOLOGICAL

Group C

0.5ml, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

vaccine made by Beijing Minhai Biotechnology Co., Ltd; vaccine made by Hualan Biological Engineering, INC

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Minhai Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

nianmin shi

Role: PRINCIPAL_INVESTIGATOR

Beijing chaoyang district center for disease control and prevention

Locations

Chaoyang District Centre for Disease Prevention and Control

Beijing, , China

Countries

China

Other Identifiers

2012L02647

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012L02647

Identifier Type: -

Identifier Source: org_study_id