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A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine

Meningococcal Meningitis Clinical Trial

Official title:
A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine

Clinical Trial Summary

Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old

Clinical Trial Description

There are five different age groups(18~55 years/7~17 years/1~6 years/7~10 months/2 months),each group has 40 people and divided into two subgroups. Each subgroup will inject different vaccine(MCV4 4μg,MCV4 8μg).For 7~10 months&2 months age groups,there are 2&3 injection seperately. Each injection interval is 1 months.

After 7 days observation of 1 dose immunization in Group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. After the first dose of 7~10 months group and evaluating safety, 2 months group immunized the first dose. All participants completed the immune procedure, then observed the safety to 30 days after whole immunization.

Data collection: Subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02481232
Study type Interventional
Source Lanzhou Institute of Biological Products Co., Ltd
Contact Zhiqiang Zhao, Manager
Phone 008613919133537
Email matinzhao@sina.com
Status Recruiting
Phase Phase 1
Start date June 2015
Completion date June 2016
View Details
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