A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens in Chinese Children

NCT03192371

Virus Diseases

WITHDRAWN PHASE4

Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen

NCT01067079

Rabies

TERMINATED

Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules

NCT01365494

Rabies

COMPLETED PHASE4

A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children

NCT02991872

Virus Diseases

COMPLETED PHASE4

A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years

NCT07275645

Rabies

NOT_YET_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1) and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2 (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine will be administered on study Day 1.

240 children and 400 older adults, a total of 640, is planned to be enrolled into the study. Subjects will be divided further into age subsets of equal numbers within each age cohort (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of age and 61 years of age and older. Within each age subset, subjects will be assigned randomly in a 1:1 ratio.

The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1) schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric mean titers (GMC), and the secondary objective is to assess the percent of subjects with rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day 15) for each schedule and age cohort

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rabies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zagreb(≥6 to ≤17 Years)

Group Type EXPERIMENTAL

Zagreb

Intervention Type BIOLOGICAL

Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22

Zagreb(≥51 Years)

Group Type EXPERIMENTAL

Zagreb

Intervention Type BIOLOGICAL

Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22

Essen(≥6 to ≤17 Years)

Group Type ACTIVE_COMPARATOR

Essen

Intervention Type BIOLOGICAL

Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29

Essen(≥51 Years)

Group Type ACTIVE_COMPARATOR

Essen

Intervention Type BIOLOGICAL

Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zagreb

Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22

Intervention Type BIOLOGICAL

Essen

Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals between 6-17 years of age and 51 years of age or older
* Individuals who were in good health
* Provided consent, complied with study procedures and duration of follow-up

Exclusion Criteria

* Contraindications to vaccination with rabies vaccine
* Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination
* Known hypersensitivity to the components of the vaccine
* Previously received any rabies vaccine or immune globulin
* Previous or planned treatment with antimalarial medications
* History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse within the past 2 years, malignancy
* Female subjects who were pregnant or unwilling to practice acceptable birth control methods
* Individuals enrolled or plans to enroll in another investigational trial

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes