Health TrialsbyHealthPanel

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

ConditionRabies
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 pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PrEP 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 ≥5years 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 (Serum-free Vero Cell), Freeze-dried

    Biological/Vaccine

    Receiving three doses of rabies vaccine rabies vaccine manufactured by Sinovac using a three-dose PrEP schedule

  • Verorab®

    Biological/Vaccine

    Receiving three doses of marketed rabies vaccine manufactured by Sanofi using the three-dose PrEP 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 RVNA titer ≥0.5 IU/mL

Time frame
Day 42 after the first dose of vaccination
2

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

Time frame
Day 28 after the first dose of vaccination

Secondary outcomes

1

GMCs of RVNA titers

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

Incidence of adverse reactions

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinovac Biotech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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