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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Dog Bite

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Detailed Description

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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.

Conditions

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Rabies Vaccine Allergy Vaccination Adverse Event Anti-D Antibodies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Zagreb2-1-1

Injection on day 0、7、21

Group Type EXPERIMENTAL

Zagreb2-1-1

Intervention Type BIOLOGICAL

Injection on day 0、7、21

Essen

Intervention Type BIOLOGICAL

Injection on day 0、3、7、14、28

Essen

Injection on day 0、3、7、14、28

Group Type ACTIVE_COMPARATOR

Zagreb2-1-1

Intervention Type BIOLOGICAL

Injection on day 0、7、21

Essen

Intervention Type BIOLOGICAL

Injection on day 0、3、7、14、28

Interventions

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Zagreb2-1-1

Injection on day 0、7、21

Intervention Type BIOLOGICAL

Essen

Injection on day 0、3、7、14、28

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes