NCT02481232

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Lanzhou Institute of Biological Products Co., Ltd · Industry
• Sex: All
• Age: 2 Months – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	freeze-dried group ACYW135 MCV	Group A, C, Y and W135 Meningococcal conjugate vaccine is suitable for immune prevention of epidemic cerebrospinal meningitis more than 2 months of age population

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2015-06-25
• Last updated: 2015-06-25

Locations

1 site across 1 country: China