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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02481232
• Other study ID #: MCV4-001
• Status: Recruiting
• Phase: Phase 1
• First received: June 23, 2015
• Last updated: June 23, 2015
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2015
• Source: Lanzhou Institute of Biological Products Co., Ltd
• Contact: Zhiqiang Zhao, Manager
• Phone: 008613919133537
• Email: matinzhao[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 55 Years

Eligibility

Inclusion Criteria:

• Healthy infants unimmunized Group A&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2~11 months-old, and healthy toddler more than 1-year-old without booster immunization.

• The guardian or himself informed consent, and signed the informed consent form;

• The guardian and family agreed to abide by the requirements of clinical trial scheme;

• Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history;

• the axillary temperature < 37.1 ?;

• 2-months-old group in the age of 61-90 days;

• 7-months-old group in the age of 211-300 days;

• 1-year-old group in age of one full year of life.

Exclusion Criteria:

• Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history;

• Neomycin, streptomycin and polymyxin B allergies;

• With immunodeficiency, immunosuppressant therapy;

• History of meningitis;

• Women in lactation or pregnant;

• Acute febrile diseases and infectious diseases;

• History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients;

• Had a severe allergic reaction of vaccination in the past;

• Took oral steroids more than 14 days in last month;

• Had high fever (axillary temperature=38.0? or higher)in the past three days;

• Prepare to attend or is in any other drug clinical study;

• Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.

Study Design

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

Related Conditions & MeSH terms

• Meningitis, Meningococcal
• Meningococcal Meningitis

Intervention

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

Locations

Country	Name	City	State
China	Hubei CDC	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Lanzhou Institute of Biological Products Co., Ltd	Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systemic and local reactions 30 days after full-course vaccination		30 days	Yes