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Comparison of adverse reactions of two rabies vaccine

A comparative study on the adverse reactions of purified chick embryo cell vaccine (PCEC) and purified vero cell rabies vaccine (VERO) administered intramuscular as post exposure prophylaxis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015102124470N1
Enrollment
1800
Registered
2015-11-13
Start date
2011-12-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Rabies. animal bites

Interventions

Intervention 1: In intervention group PCEC will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and th
Treatment - Drugs
In intervention group PCEC will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vac
In control group Vero will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vaccinat

Sponsors

Center of Disease Control (CDC), Ministry of Health, Tehran, Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 55 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: age between 5 and 55 years; volunteer to participate in the study. exclusion criteria: have a history of previous animal bites; receiving immunization against rabies previously; have a significant acute or chronic infectious disease; receiving transfusion with blood or blood products within the past month; concomitantly receiving corticosteroids or immunosuppressive drug therapy; have axillary temperature 37.5°C before injection; being pregnant in females

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Lymphadenopathy. Timepoint: 30 minutes after each injection. Method of measurement: By physician.;Bruising. Timepoint: 30 minutes after each injection. Method of measurement: By physician.;Ittching. Timepoint: 30 minutes after each injection. Method of measurement: By physician.;Abscesses. Timepoint: 30 minutes after each injection. Method of measurement: b.;Erythema. Timepoint: 30 minutes after each injection. Method of measurement: By physician.;Swelling. Timepoint: 30 minutes after each injection. Method of measurement: By physician.

Secondary

MeasureTime frame
Dizziness. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.;Stomach ache. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.;Nausea. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.;Weakness. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.;Muscle aches. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.;Fever. Timepoint: 3 days after each injection. Method of measurement: evaluated daily by patients.;Vomiting. Timepoint: 3 day after each injection. Method of measurement: evaluate by the patirnt.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoghieh Ramezankhani

Center of Disease Control (CDC), Ministry of Health, Tehran, Iran

minoo.ramezani@gmail.com+98 21 8145 5016

Outcome results

None listed

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