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

Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003313
• Other study ID #: 2012L02647
• Secondary ID: 2012L02647
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2013
• Last updated: September 19, 2015
• Start date: November 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Beijing Minhai Biotechnology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1260
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis

Intervention

Biological:
• Group T
0.5ml, Intramuscular
• Group C
0.5ml, Intramuscular

Locations

Country	Name	City	State
China	Chaoyang District Centre for Disease Prevention and Control	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Minhai Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination		28 days after vaccination	No
Secondary	to evaluate the adverse reactions after vaccination		within 28 days after vaccination	Yes