CompletedPhase 3

Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

China1,800 participantsStarted 2020-07-22

Plain-language summary

A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)

Who can participate

Age range10 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The age is 10-60 years old; * Underarm temperature ≤ 37.0 ℃. Exclusion Criteria: * Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents； * Has been diagnosed with congenital or acquired immunodeficiency disease； * Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

What they're measuring

Antibody positive conversion rate of experimental groups

Timeframe: 3 months

Antibody positive conversion rate of 4 doses groups

Timeframe: 3 months

Compare the GMT between two experimental groups

Timeframe: 3 months

Geometric Mean Titer (GMT) of 4 doses groups

Timeframe: 3 months

Safety within 30 minutes

Timeframe: 3 months

Safety within 0-7 days

Timeframe: 3 months

Safety within 6 months

Timeframe: 9months

Trial details

NCT IDNCT05549908

SponsorChangchun Zhuoyi Biological Co., Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-31

View on ClinicalTrials.gov More Rabies Human trials