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A randomized, blind, active-controlled trials to evaluate the safety andimmunogenicity of freeze-dried rabies vaccine(vero cell) for Human use in the healthy subjects among 10 to 50 years old.

A randomized, blind, active-controlled trials to evaluate the safety andimmunogenicity of freeze-dried rabies vaccine(vero cell) for Human use in the healthy subjects among 10 to 50 years old.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PPR-15007057
Enrollment
Unknown
Registered
2015-09-14
Start date
2015-05-08
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

rabies

Interventions

Trial :rabies vaccine with 5 injections at day 0, 3, 7, 14, 28
Trial :rabies vaccine with 4 injections at day 0 (twice a day), 7, 21
Control :rabies vaccine with 5 injections at day 0, 3, 7, 14, 28

Sponsors

Hubei provincial center for disease control andprevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Healthy permanent residents aged 10- 50 years; 2. Agree to participate the trial, andsigned the informed consent form; 3. The subjects andtheir guardians can comply with the requirements of clinical trial scheme; 4. Subjects has no history of rabies vaccine inoculation; 5. Subjects has no history of other vaccine , antiserum andimmunoglobulin preparations in the past 1 month; 6. the axillary temperature <=37.0 degree C.

Exclusion criteria

Exclusion criteria: 1. Have allergies, convulsions, epilepsy, encephalopathy andpsychiatric medical history or epilepsy family history; 2. Allergy to the main ingredients of the vaccine; 3. Subjects with known immunodeficiency or splenectomy; 4. Subjects had high fever (axillary temperature>38.0 degree C or higher) in the past three days; 5. Congenital malformations, developmental disorders,severe chronic diseases,severe cardiovascular diseases, diabetes, unstable hypertension cannot controlled by drugs, liver andrenal diseases andmalignant tumors, etc; 6. Subjects with acute andchronic infectious diseases,active infection,severe asthma andinfectious dermatosis, etc.; 7. Pregnancy women or breastfeeding women; 8. Any situation which the researchers think that may affect test evaluation.

Design outcomes

Primary

MeasureTime frame
Adverse reaction rate;the antibody concentration of rabies virus;

Countries

China

Contacts

Public ContactFaxian Zhan
zhanfx@163.com+86 13908639947

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026