Completed

Phase 4 Study of Speeda® Rabies Vaccine for Human Use

What is being tested

Zagreb2-1-1

+ Essen

+ Zagreb2-1-1

Biological

Who is being recruted

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 4

Interventional

Study Start: July 2012

See protocol details

Summary

Principal SponsorBeijing Center for Disease Control and Prevention

Last updated: January 20, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01821911

Principal SponsorBeijing Center for Disease Control and Prevention

Last updated: January 20, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

10500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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 body temperature <= 37.0°C

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 without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)

9 exclusion criteria prevent from participating

An acute illness with or without fever (temperature > 37.0°C) in the latest week preceding enrollment in the trial

Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study

Known allergy to any constituent of the vaccine

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Injection on day 0、7、21

Group II

Active Comparator

Injection on day 0、3、7、14、28

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Guangdong Centers for Disease Control and Prevention

Zhaoqing, ChinaOpen Guangdong Centers for Disease Control and Prevention in Google Maps

Wuhan Centers for Disease Control and Prevention

Wuhan, China

Beijing Chaoyang District Centers for Disease Control and Prevention

Beijing, China

Completed3 Study Centers