CTRI/2024/04/066095招募中3 期
An Observer-blind, Randomized, Active-controlled, Multi-centric Phase III Study in Infants and Toddlers to Assess the Immunogenicity and Safety of SIIPL HEXAVALENT (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV in Comparison with SIIPL HEXASIIL®. - NI
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Infants aged 6-8 weeks at the time of first vaccination.
- •2.Infants with good health.
- •3.Informed consent form signed by parent.
- •4.Infants born at full term pregnancy.
- •5.Infants with weight-for-length z-score = -2 SD at the time of enrolment.
- •6. Willingness of subject parent to comply with the the protocol.
排除标准
- •1.History of diphtheria/ tetanus/ pertussis/ hepatitis B/Haemophilus Influenzae type b/ poliomyelitis infection(s).
- •2.Presence of fever.
- •3.Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.
- •4.Receipt of antibiotics in the past 3 days.
- •5.Previous vaccination or planned receipt of any vaccine against D,T,P,HepB, (except birth dose),
- •poliomyelitis (except OPV birth dose) or Hib type b apart from trial vaccines.
- •6.Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination.
- •7.History of major congenital defects or illness that require medical therapy.
- •8.History of any clinically significant chronic disease which may interfere with the study outcome.
- •9.History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine.
- •10.Infants with known or suspected impairment of the immune function.
- •11.Presence of evolving or changing neurological disorder or infant with a history of seizures.
- •12.Known thrombocytopenia or a bleeding disorder.
- •13.Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.
- •14.Planned surgery during the study.
- •15.Receipt of blood or blood-derived products or immunoglobulins.
- •16.Participation in another clinical trial 4 weeks preceding the trial
- •enrolment or planned participation during the present trial period.
- •17.Infants whose families are planning to leave the area of the study site.
研究者
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