A clinical study to assess the safety and immune response of rabies vaccine of Serum Institute of India Ltd (SIIL).

A Randomized, Open Label, Active Controlled, Phase I Clinical Study to Assess the Safety and Immunogenicity of SIIL?s Purified Vero Cell Rabies Vaccine (PVRV) in Healthy Adults as a Pre-Exposure Immunization.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/07/001903

Enrollment

Registered

2011-07-19

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

None listed

Interventions

Intervention1: Vero Cell Rabies Vaccine (PVRV): Dose: 1 ml for intramuscular injection on Day 0, 7 and 21. 0.1 ml for intradermal injection on Day 0, 7 and 21. Control Intervention1: Vero Cell Rabies

Eligibility

Inclusion criteria

Inclusion criteria: Willing to give informed consent and whose clinical laboratory examinations are within the clinically acceptable normal range.

Exclusion criteria

Exclusion criteria: 1. Subjects participating in any other clinical trial, 2. previous history of Rabies. 3. received rabies immunoglobulin 4. febrile illness. 5. Known systemic hypersensitivity to vaccine components 6. pregnancy or positive urine pregnancy test. 7. Breast-feeding 8. thrombocytopenia 8. subject at high risk for rabies exposure during the trial period. 9. concomitant antimalarial drugs.

Design outcomes

Primary

Measure	Time frame
SafetyTimepoint: Solicited reactions within 7 days and Unsolicited adverse events and serious adverse events (SAEs) within 42 days.	—

Secondary

Measure	Time frame
Immune responseTimepoint: Virus neutralizing antibody on Days 0, 7, 21 and 42.	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni

drpsk@seruminstitute.com02026602384

Outcome results