The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use

Beijing Center for Disease Prevention and Control

Status and phase: Completed; Phase 4

Conditions: Rabies Vaccine Allergy; Anti-D Antibodies; Vaccination Adverse Event

Treatments: Biological: Essen; Biological: Zagreb2-1-1

Study type: Interventional

Funder types: Other

Identifiers

NCT01821911

BJCDPC-5

Details and patient eligibility

About

The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio

Full description

The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.

Enrollment: 10,500 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
• Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
• Participant body temperature ≤ 37.0℃
• Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)

Exclusion criteria

• Three-level exposure
• Known allergy to any constituent of the vaccine
• Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
• Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
• Participation in any other interventional clinical trial
• An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
• Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
• Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
• Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,500 participants in 2 patient groups

Zagreb2-1-1

Experimental group

Description:

Injection on day 0、7、21

Treatment:

Biological: Essen

Biological: Zagreb2-1-1

Essen

Active Comparator group

Description:

Injection on day 0、3、7、14、28

Treatment:

Biological: Essen

Biological: Zagreb2-1-1