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Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine

C

Changchun Zhuoyi Biological

Status and phase

Completed
Phase 4

Conditions

Rabies
Antibody

Treatments

Biological: 5 doses program

Study type

Interventional

Funder types

Other

Identifiers

NCT05547815
ZY201909001

Details and patient eligibility

About

Evaluation of immune persistence after rabies vaccination in 150 people.

Full description

150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.

Enrollment

149 patients

Sex

All

Ages

10 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 10-60 years old;
  • Temperature on the day of admission≤37.0 ° C (axillary temperature).

Exclusion criteria

  • Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents;
  • Has been diagnosed with congenital or acquired immunodeficiency disease;
  • Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

149 participants in 1 patient group

experimental arm
Experimental group
Description:
5 doses of rabies vaccine
Treatment:
Biological: 5 doses program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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