Study to check safety of Rabishield and Rabivax-S vaccines in patients with animal bites by suspected rabid animals

Phase 4

Active, not recruiting

Brief Summary: This is an open label, phase IV, randomized, controlled study. Safety (in all participants) and immunogenicity (in a subset) of Rabishield + Rabivax-S and ERIG + Rabivax-S PEP regimen will be evaluated. Rabivax-S will be administered either by intramuscular (IM) route as per Essen PEP regimen or intradermal (ID) route as per Updated Thai Red Cross Schedule in patients with WHO category III exposures by suspected rabid animals as per randomization. Category III exposures include single or multiple transdermal bites or scratches, contamination of mucous membrane or broken skin with saliva from animal licks, and exposures due to direct contact with bats (severe exposure). All the participants will be followed up for 1 year for safety.

Recruitment & Eligibility

Inclusion Criteria

Patients aged more than 2 years of either sex 2.
WHO Category III exposure(s) by a suspected rabid animal < 72 hours prior to enrollment and < 24 hours if exposure to face, neck, hand or fingers.
Written informed consent by subjects (â‰¥18 years) / parents of subjects (2-17 years).
Written informed assent by subjects aged 7-17 years.

Exclusion Criteria

Previous receipt of complete PEP or pre-exposure prophylaxis with modern cell culture rabies vaccine.
Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination, which in the opinion of the investigator might interfere with the study objectives.
Major congenital defects or serious chronic illness.
History of thrombocytopenia or known bleeding disorders.
Receipt of other investigational study agent within previous 30 days or planned during the course of this study.
Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant participating in the study or making it unlikely the subject could complete the protocol.

Primary Outcome Measures

Name	Time	Method
Incidence of related serious adverse events (SAEs) through 365 days after Day 0 immunization	Through 365 days after Day 0 immunization

Secondary Outcome Measures

Name	Time	Method
1. Incidence of all SAEs through 365 days after Day 0 immunization	2. Adverse events (AEs) through 3 days after last dose of PEP regimen

Locations (19): B. J. Govemment Medical College and Sassoon General Hospitals. Pune
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Pune, MAHARASHTRA, India
Christian Medical College, Ludhiana
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Ludhiana, PUNJAB, India
Government Medical College & Hospital, Nagpur
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Nagpur, MAHARASHTRA, India
Government Medical College, Jammu
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JAMMU, & KASHMIR, India
Indira Gandhi Govt. Medical College, Nagpur
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Nagpur, MAHARASHTRA, India
Institute of Post Graduate Medical Education & Research
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Kolkata, WEST BENGAL, India
Kasturba Medical College, Manipal,
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Udupi, KARNATAKA, India
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre
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Bangalore, KARNATAKA, India
Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai
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Mumbai, MAHARASHTRA, India
Mandya Institute of Medical Sciences, Mandya
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Mandya, KARNATAKA, India
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B. J. Govemment Medical College and Sassoon General Hospitals. Pune
🇮🇳Pune, MAHARASHTRA, India
Dr Muralidhar Tambe
Principal investigator
9423007898
muralidhartambe@rediffmail.com