Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

Meningitis, Meningococcal Clinical Trial

Official title:

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878291
• Other study ID #: 201518603
• Status: Recruiting
• Phase: Phase 1
• First received: August 22, 2016
• Last updated: August 25, 2016
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Beijing Zhifei Lvzhu Biopharmaceutical 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 study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• 3-11 months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.

• Subject or legal representative who consent and has signed written informed consent.

• Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.

• Subject and parent/guardian who is able to comply with all study procedures.

• Axillary temperature =37.0 ?.

Exclusion Criteria:

• History of allergy,eclampsia, epilepsy, encephalopathy and mental disease or family disease.

• Allergic history after vaccination.

• History of meningitis infection disease.

• Acute Febrile illness and Infectious Diseases.

• Febrile illness (temperature = 38°C) in the 3 days.

• Immunodeficiency diseases patients who administered with immunosuppressive agents.

• Children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease.

• Liver and kidney or cardiopulmonary disease,acute hypertension and diabetes.

• In pregnancy or lactation or pregnant women.

• Subject who plan to participate in or is in any other drug clinical trial.

• Meningococcal vaccine contraindication.

• Any condition that, in the judgment of investigator, may affect trial assessment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal

Intervention

Biological:
• Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.
• Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.

Locations

Country	Name	City	State
China	Sanjiang Center for Disease Control and Prevention	Sanjiang	Guangxi

Sponsors (6)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd	Fourth Military Medical University, Guangxi Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Sanjiang Center for Disease Control and Prevention, Simoon Record Pharma Information Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events during a 30 day follow-up period after each vaccination		30 day after each vaccination	Yes