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Safety and immunogenicity of rabies vaccines in animal bite cases administered using new one week intradermal regimen

A clinical evaluation of safety and immunogenicity of Purified chick embryo cell vaccine and Purified verocell rabies vaccine administered using one week intradermal regimen (4-4-4-0-0) in animal bite cases.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003230
Enrollment
80
Registered
2012-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Animal bite cases

Interventions

Intervention1: Purified chick embryo cell rabies vaccine: 0.1 mL x 4 sites on days 0,3,7 administered intradermally Control Intervention1: Purified Verocell rabies vaccine: 0.1 mL x 4 sites on days 0,

Sponsors

Department of Community Medicine Kempegowda Institute of Medical Sciences KIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Animal bite cases with category II & III reporting within 72 hours of exposure 2) Subjects willing to give signed informed consent 3) Subjects willing to give blood samples on days 0,14,90

Exclusion criteria

Exclusion criteria: 1) Subjects who have received anti rabies vaccine and any type of anti-sera in the past. 2) Subjects with chronic diseases like Diabetes Mellitus, Hypertension and Tuberculosis. 3) Subjects who are immunocompromised & are on immunosuppressive therapy like long acting steroids, anti cancer drugs & radiation therapy. 4) Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Estimation of rabies virus neutralizing antibody titres of more than or equal to 0.5 IU/mLTimepoint: Day 14

Secondary

MeasureTime frame
Incidence of local and systemic adverse drug reactions to Rabipur and VerorabTimepoint: Till day 14

Countries

India

Contacts

Public ContactDr D H Ashwath Narayana

Kempegowda Institute of Medical Sciences

m_aravind86@yahoo.co.in09845502944

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 4, 2026