None listed
Conditions
Interventions
Intervention1: THRABIS vaccine (Recombinant Rabies G Protein Vaccine) by Cadila Pharmaceuticals Limited, India.: Single 50 μg/0.5 mL Intramuscular (IM) injection, each, on Day 0, 3, 7
Control Interve
Sponsors
Cadila Pharmaceutical Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy subjects of either gender, between the age of 1 years to 2.Subjects who are in good health at the time of enrolment into the study. 3. Subjects with seronegative status for RVNA titers at screening 4.Subject, subjectâ??s parent(s) or LAR(s) agrees to comply with protocol requirements and able to sign and date a written, ICF and assent form. 5.Documented negative test for human immunodeficiency virus (HIV-1/2),HBsAg or HCV. 6.Female subject with negative Urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1.Any condition likely to interfere with evaluation of the vaccine or having potential health risk to the child or make it unlikely that the child would complete the study. 2.History of receiving Rabies vaccine or any animal bite within the past 12 months. 3.Subject with known allergy to vaccine components 4.Subject with any known immune compromising condition or receiving immunosuppressive therapy within 6 months preceding enrolment. 5.Subject with history of any chronic illness, heart, respiratory, liver or kidney disease, mental disorders, seizures or progressive neurological disease. 6.Subject receiving antimalarial treatment 7.Subject in whom blood sampling will be difficult. 8.Subjects with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor. 9.Documented fever of > 100.4°F or above as axillary temperature in the preceding 14 days. 10.Administration of immunomodulating agents within six months prior to administration of study medications. 11.Pregnant and lactating girls and female subjects of child bearing age not using acceptable contraceptive measures. 12.Participation in another clinical trial during the 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare seroprotection rate between test vaccine and reference vaccineTimepoint: At day 14 after first dose of study vaccines | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate seroprotection rate of the study vaccines.Timepoint: At day 42 after first dose of study vaccines;To evaluate the safety and tolerability of study vaccinesTimepoint: Till day 42 after first dose of study vaccines | — |
Countries
India
Contacts
Public ContactDr Krunal Prajapati
Cadila Pharmaceuticals Limited
Outcome results
None listed