A Phase III Bridging study to evaluate Immunogenicity and Safety of a Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis) as compared to the licensed vaccine, Shan5 (with imported pertussis) when administered as three dose primary series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,040
- 试验地点
- 17
- 主要终点
- To demonstrate the non-inferiority of the Pentavalent vaccine (DTwP-HepB-Hib), Shan5 (with Shantha pertussis) to licensed vaccine Shan5 (with imported pertussis) in terms of eroprotection/seroresponse rates to all antigens
研究概览
简要总结
This is a Phase III, Multi-center, Randomized,Two-Arm, Single Blind study planned to be conducted in 1040 infants across inIndia. The eligible infants will be randomized in 1:1 ratio to receive eitherPentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis) or thelicensed vaccine Shan5 (with imported pertussis). The randomized infants willreceive 03 doses of respective vaccine at 6-8, 10-12 and 14-16 weeks of age asper the EPI schedule. The vaccinated infants will be observed for 30 minutespost-vaccination to observe for any immediate adverse events and followed upfor safety and immunogenicity for 28 days following each dose of the vaccine.Approximately 3.5 to 5 mL of two (2) blood samples, one just before the firstdose of vaccination and another one 1 month after the third dose of vaccinationwill be collected from all the enrolled subjects. Serum samples prepared fromthese blood samples will be analyzed for Seroprotection of Diphtheria, Tetanus,Hepatitis B and Haemophilus influenzae type b antigens as well as Seroresponsefor Pertussis antigen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 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
- •1.Healthy Infants of either sex between 42-56 days (6 to 8 weeks) of age on the day of enrollment 2.Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
- •3.Informed consent form signed by parent or legally acceptable representative (LAR) as per local requirements.
- •4.Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment: 1.Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- •2.Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
- •3.Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV if not given at birth and during National Immunization Day (NID).
- •4.Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- •5.Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial.
- •6.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth).
- •7.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections (confirmed either clinically, serologically or microbiologically).
- •8.Known personal or maternal history of HIV or hepatitis B seropositivity.
- •9.Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
- •10.Known thrombocytopenia, as reported by the parent/ legally acceptable representative.
- •11.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
- •12.Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- •(Chronic illness may include, but is not limited to, cardiac, renal, autoimmune, hepatic, haematological, genetic disorders, atopic conditions, congenital defects, diabetes, convulsions or encephalopathy etc.).
- •13.Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 100.4 °F or ≥38 °C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided).
- •14.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
- •15.Subject with definite seizure disorder and getting anticonvulsant therapy.
结局指标
主要结局
To demonstrate the non-inferiority of the Pentavalent vaccine (DTwP-HepB-Hib), Shan5 (with Shantha pertussis) to licensed vaccine Shan5 (with imported pertussis) in terms of eroprotection/seroresponse rates to all antigens
时间窗: one month after a three-dose primary series.
次要结局
- Safety and Immunogenicity(One month after dosing)