Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorSinovac Biotech Co., Ltd

About this trial

To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after post-exposure prophylaxis (PEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PEP schedule

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Populations aged ≥1 years old;

Participants and/or participants' parents/legal guardians are able to understand and sign the informed consent form (ICF) voluntarily;

Participants are able to comply with the study procedures based on the investigator's assessment;

In a stable health status (defined as a stable preexisting disease status during the past 3 months, i.e., no change in treatment or hospitalization due to exacerbation of preexisting diseases);

Disqualifiers

Fever on vaccination day, with axillary temperature >37.0°C (aged ≥5 years old) or >37.3°C (aged 1~4 years old) pre-vaccination;

Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;

Previous administration with rabies immunoglobulins or monoclonal antibodies;

Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rabies vaccine

    Biological/Vaccine

    Receiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule

  • Verorab®

    Biological/Vaccine

    Receiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: Sinovac rabies vaccineExperimental treatment 1 intervention
Group B: Sanofi Pasteur Verorab®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL

Time frame
Day 14 and Day 28 after the first dose vaccination

Secondary outcomes

1

Geometric mean concentrations (GMCs) of RVNA titers

Time frame
Day 14, Day 28 and Day 42 after the first dose vaccination
2

Proportion of participants achieving a RVNA titer ≥0.5 IU/mL

Time frame
Day 42 after the first dose vaccination
3

Incidence of adverse reactions

Time frame
Up to 28 days after the last-dose vaccination

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: