Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSinovac Biotech Co., Ltd

About this trial

To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants are able to understand and voluntarily sign the Informed Consent Form;

Able to provide legal identity documents;

Age 18 to 45 years;

Stable health status (defined as stable underlying disease status within 3 months prior to enrollment, i.e., no change in original treatment or hospitalization due to disorder aggravation);

Disqualifiers

For subjects with pyrexia on the scheduled vaccination day, axillary temperature >37.3℃ before vaccination;

Previous use of anti-Rabies Passive immunization preparations (including but not limited to equine-derived Immunoglobulin ERIG, human-derived Immunoglobulins HRIG, and rabies monoclonal antibody preparations, etc.) or previous Vaccination with human Rabies Vaccine;

Individuals with mammalian animal bites/scratches (e.g., dog/cat) and broken skin (i.e., Category II or higher exposure) within the past year.;

Female participants who are lactating or pregnant (including those with a positive urine pregnancy test).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sinovac rabies vaccine

    Biological/Vaccine

    Three batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules

Treatment groups

912 Participants
are divided into 3 treatment groups
Group A: Sinovac rabies vaccine - Batch 1Experimental treatment 1 intervention
Group B: Sinovac rabies vaccine - Batch 2Experimental treatment 1 intervention
Group C: Sinovac rabies vaccine - Batch 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group

Time frame
Day 14 after the first-dose vaccination

Secondary outcomes

1

GMC of rabies neutralizing antibody

Time frame
Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
2

Seroconversion Rate of rabies neutralizing antibody

Time frame
Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
3

Incidence of adverse reactions

Time frame
Up to 30 days after the last-dose vaccination
4

Incidence of serious adverse events

Time frame
Up to 30 days after the last-dose vaccination

Other outcomes

Sponsors and contacts

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

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