A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Healthy Infants In India
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 211
- 试验地点
- 6
- 主要终点
- Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis
研究概览
简要总结
This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment.
It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.
详细描述
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of Serum Institute of India Ltd. delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. Diphtheria, Tetanus, Pertussis, Hepatitis B (HBsAg) and Hemophilus Influenza B at 28 days after administration of a third dose of the vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy infants of age 6-8 weeks at the time of the first vaccination.
- •Born after a normal gestation period (36-42 weeks).
- •Parents of subjects willing to give written informed consent.
- •Parents willing to comply with study protocol.
- •Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
- •The participant should be the resident of study area
排除标准
- •Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period.
- •Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy for a period of ≥ 1 week.
- •Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- •Infant with any chronic illness including hepatic, renal, respiratory, CVS, endocrine and neurological illness.
- •Infants who have received blood or blood-derived products in the past.
- •History of diphtheria, tetanus, pertussis, and hepatitis B or Haemophilus influenzae type b (confirmed either clinically, serologically or microbiologically).
- •Previous history of vaccination against the diphtheria, tetanus, pertussis or Hib.
- •Known history of a bleeding disorder contraindicating intramuscular vaccination.
- •History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
- •History of febrile illness at the time of inclusion is a temporary exclusion criterion.
- •Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives
- •Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol
研究组 & 干预措施
DISPOSABLE-SYRINGE JET INJECTOR (DSJI)
Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc
干预措施: DTP-HB-Hib vaccine (Biological)
DISPOSABLE-SYRINGE JET INJECTOR (DSJI)
Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc
干预措施: Disposable Syringe Jet Injector (DSJI) (Device)
NEEDLE & SYRINGE (N-S)
Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via conventional needle and Syringe
干预措施: DTP-HB-Hib vaccine (Biological)
NEEDLE & SYRINGE (N-S)
Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via conventional needle and Syringe
干预措施: Needle & Syringe (Other)
结局指标
主要结局
Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis
时间窗: one month after administration of third dose of the vaccine
次要结局
- Occurrence of adverse event(84 days after first vccine dose)
- Occurrence of serious adverse event(84 days after first vccine dose)
- Occurrence of solicited reactions(within 4 days following the administration of each of the three vaccine dose)