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Post-marketing safety monitoring of lyophilized human rabies vaccine (Vero cells)

Post-marketing safety monitoring of lyophilized human rabies vaccine (Vero cells)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074983
Enrollment
Unknown
Registered
2023-08-22
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rabies

Interventions

Group 1:Five-shot procedure, 1 dose of vaccine was intramuscularly injected at one site on days 0, 3, 7, 14 and 28
Group 2:In the four-needle procedure, one dose of vaccine was intramusculally injected at two different sites on day 0, and one dose was intramusculally injected at one site on day 7 and 21.
Group 3:The doctor of the inoculation unit introduced the safety, protective effect and difference of the five and four acupuncture methods to the recipients, and the recipients independently selected

Sponsors

Sichuan Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: Active monitoring discharge criteria: (1) Confirmed or suspected rabies exposure (including simultaneous antiserum vaccination); (2) The recipient or his/her guardian can understand and agree to cooperate with the active monitoring according to the requirements of the program; (3) Voluntarily participate in the study and sign the informed consent; (4) Provide valid legal identification. Passive monitoring input and discharge standards: (1) Voluntarily or at one's own expense to receive the vaccine in this study; (2) Informed consent signed by the recipient or his guardian; (3) Provide valid legal proof of identity.

Exclusion criteria

Exclusion criteria: (1) The recipient or guardian voluntarily requests to withdraw from the study; (2) Adverse events that cannot be tolerated, whether or not related to the investigational vaccine; (3) The health condition of the recipients does not allow them to participate in the study; (4) If the recipient has any abnormal clinical manifestations, the researcher will determine whether it is related to vaccination and whether the recipient should suspend the study; (5) any other cause considered by the researcher.

Design outcomes

Primary

MeasureTime frame
security;

Secondary

MeasureTime frame
compliance;

Countries

China

Contacts

Public ContactQi Qi

Sichuan Center for Disease Control and Prevention Immunization Program

250877069@qq.com+86 28 8558 6701

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026