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

Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine in More Than 2 Years Old Children and Adults

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.

Study Overview

• Status: Completed
• Conditions: Meningitis
• Intervention / Treatment: Biological: Group T; Biological: Group C

• Study Type: Interventional
• Enrollment (Actual): 1260
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Chaoyang District Centre for Disease Prevention and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group T; Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.	Biological: Group T; 0.5ml, Intramuscular; Other Names: vaccine made by Beijing Minhai Biotechnology Co., Ltd
Active Comparator: Group C; Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine.	Biological: Group C; 0.5ml, Intramuscular; Other Names: vaccine made by Hualan Biological Engineering, INC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
to evaluate the adverse reactions after vaccination	within 28 days after vaccination

Collaborators and Investigators

• Sponsor: Beijing Minhai Biotechnology Co., Ltd
• Investigators: Principal Investigator: nianmin shi, Beijing chaoyang district center for disease control and prevention

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 28, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 19, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: safety, immunogenicity, Meningococcal Polysaccharide Vaccine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2012L02647 (Registry Identifier: China food and drug administration)