A prospective, randomized, two-arm, single-blind, parallel, active-controlled, multicentre,non-inferiority, phase II/III clinical study to evaluate the immunogenicity and safety ofDiphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) of M/s Cadila Healthcare Limited compared to Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) of M/s Serum Institute of India Limited in healthy infants

Cadila Healthcare Ltd0 个研究点目标入组 288 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Healthy infant of either gender between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) at the time of enrollment
•2. Subject born after a normal gestational period of 37-42 weeks with birth weight >= 2.5 Kg
•3. Body weight >= 3.3 Kg at the time of enrollment
•4. Subject in a good clinical condition as judged by the investigator based on medical history and physical examination
•5. Written informed consent obtained from the subjectâ??s parents or legally acceptable representative
•6. Subjectâ??s parents or legally acceptable representative literate enough to fill the diary card

•1. Any vaccination before enrollment except vaccination with BCG vaccine, Hepatitis-B vaccine and oral polio vaccine
•2. Past history of diphtheria, pertussis or tetanus
•3. History of known or suspected allergy to any of the vaccine components
•4. History of thrombocytopenia or any coagulation disorder, or subject on anticoagulation therapy
•5. Subject with any clinically significant congenital disorder, immunodeficiency disorder and subject on any immunosuppressive or immunostimulant therapy
•6. Subject with history of clinically significant systemic disorder especially neurological disorder
•7. Known personal or maternal history of HIV, Hepatitis-B (HBsAg) or Hepatitis-C seropositivity
•8. History of any acute illness within the past 1 week
•9. Subject with febrile illness (axillary temperature >= 37.5 0C) at the time of enrollment
•10. Planned or elective surgery during the course of the study
•11. History of administration of blood, any blood containing product or immunoglobulins since birth
•12. Participation of subject in any clinical trial since birth or participation of subjectâ??s mother in any clinical trial within the past 30 days

发起方