CompletedNot Applicable

Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly

Vietnam120 participantsStarted 2015-10

Plain-language summary

An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.

Who can participate

Age range5 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

✓. Healthy male or female aged from 5 years old. Women of childbearing age must use an appropriate method of contraception.
✓. Subjects had sign written consent form to participate in the study. With subjects aged from 5 to below 18 years old, parents/legal representative had sign written consent form for children to participate in this study.
✓. Subject who gave voluntary to comply with the study requirements.

Exclusion criteria

✕. Subjects have atopic allergy or severe allergy to any component of vaccine.
✕. Subjects with mental illness, mental retardation.
✕. Subjects with severe acute or chronic disease may affect safety (eg: hepatobiliary disease, kidney disease, diabetes, hypertension…).
✕. Subjects received rabies vaccine.
✕. Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
✕. Subjects who received other vaccine within 28 days before INDIRAB® vaccination, or those who had another vaccination schedule during the study.
✕. Pregnant or lactating women.
✕. Subjects had been participated, are participating, are going to participate in any other clinical trials during the period of this study.

What they're measuring

Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general).

Timeframe: 30 minutes after vaccination

Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of solicited and unsolicited adverse events.

Timeframe: For 7 days after each vaccination

Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of Serious Adverse Events.

Timeframe: Within 35 days after the first vaccination

Trial details

NCT IDNCT02729168

SponsorInstitute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Rabies trials