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
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 8
- 主要终点
- Proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at day 84
研究概览
简要总结
This is a randomized, single blind, parallel, active controlled, non-inferiority, multicentre clinical trial to evaluate and compare the immunogenicity and safety of DPT vaccine of M/s Cadila Healthcare Ltd. with DPT vaccine of M/s Serum Institute of India Ltd. in healthy infants. Blood samples will be collected pre-vaccination (day 0) & at 28 days after last vaccination (day 84) to determine anti-diphtheria, anti-tetanus and anti-pertussis antibody titres. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies post-vaccination. The sero-protective cut-off titre for serum anti-diphtheria & anti-tetanus antibodies is 0.1 IU/ml. The sero-protective cut-off titre considered for serum anti-pertussis antibodies is 22 U/ml. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 42.00 Day(s) 至 56.00 Day(s)（—）
- 性别
- All
入选标准
- •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
- •Subject born after a normal gestational period of 37-42 weeks with birth weight ≥ 2.5 Kg
- •Body weight ≥ 3.3 Kg at the time of enrollment
- •Subject in a good clinical condition as judged by the investigator based on medical history and physical examination
- •Written informed consent obtained from the subject’s parents or legally acceptable representative
- •Subject’s parents or legally acceptable representative literate enough to fill the diary card.
排除标准
- •Any vaccination before enrollment except vaccination with BCG vaccine, Hepatitis-B vaccine and oral polio vaccine
- •Past history of diphtheria, pertussis or tetanus
- •History of known or suspected allergy to any of the vaccine components
- •History of thrombocytopenia or any coagulation disorder, or subject on anticoagulation therapy
- •Subject with any clinically significant congenital disorder, immunodeficiency disorder and subject on any immunosuppressive or immunostimulant therapy
- •Subject with history of clinically significant systemic disorder especially neurological disorder
- •Known personal or maternal history of HIV, Hepatitis-B (HBsAg) or Hepatitis-C seropositivity
- •History of any acute illness within the past 1 week
- •Subject with febrile illness (axillary temperature ≥ 37.5 0C) at the time of enrollment
- •Planned or elective surgery during the course of the study
- •History of administration of blood, any blood containing product or immunoglobulins since birth
- •Participation of subject in any clinical trial since birth or participation of subject’s mother in any clinical trial within the past 30 days.
结局指标
主要结局
Proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at day 84
时间窗: 28 days following last vaccination (day 84
次要结局
- Geometric mean titre of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at baseline and at day 84(28 days following last vaccination (day 84))