A randomized, open-label, assessor blind, parallel, active-controlled, multicentric, bridging clinical trial to evaluate the immunogenicity and safety of three dose THRABIS vaccine (Recombinant Rabies G Protein Vaccine), administered as a simulated post-exposure immunization in healthy children - THRABIS vaccine

Cadila Pharmaceutical Limited0 个研究点目标入组 354 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•1.Healthy subjects of either gender, between the age of 1 years to <18 years with no prior history of receipt of rabies immune globulin and /or rabies vaccine.
•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.

•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 > 100.4Â°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.

发起方

Cadila Pharmaceutical Limited