CTRI/2019/11/022052已完成2 期
An open label, randomized, active controlled, multicentric Phase II/III study in Indian toddlers and infants to assess the immunogenicity and safety of SIIPL HEXASIIL (DTwP-HepB-IPV-Hib) vaccine in comparison with SIIPL Pentavac (DTwP-HepB-Hib) plus Poliovac (IPV) vaccines, administered as separate injections.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,548
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
- •For Part I (Toddler)
- •1.Toddlers aged between 12-24 months at the time of vaccination.
- •2.Toddlers with a good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
- •3.Toddlers who have completed primary immunization series against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus Influenzae type b at least 6 months prior to enrolment and have not received the booster dose for the above-mentioned vaccines scheduled at 12-24 months of age.
- •4.Informed consent form signed by at least one parent.
- •5.The weight-for-length z-score for the toddler is greater than or equal to -2 Standard Deviation at the time of enrolment.
- •6.Willingness of subjects’ parent to comply with requirements of the protocol.
- •For Part II (Infant)
- •1.Male or female infants aged 6-8 weeks at the time of first vaccination.
- •2.Infants with a good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
- •3.Infants who have received the birth doses of OPV and BCG at least 4 weeks before the first trial vaccination.
- •4.Informed consent form signed by at least one parent.
- •5.Infants born at full term pregnancy (greater than or equal to 37 weeks).
- •6.Infants with weight-for-length z-score greater than or equal to -2 SD at the time of enrolment.
- •7.Willingness of subjects’ parent to comply with requirements of the protocol.
排除标准
- •1.History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus Influenzae type b/poliomyelitis infection(s) (confirmed either clinically, serologically or microbiologically).
- •2.Fever greater than or equal to 38°C/100.4°F and/or any evidence of acute illness and/or receipt of antibiotics in the past 3 days.
- •3.History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
- •4.History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- •5.History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine.
- •6.Presence of evolving or changing neurological disorder or toddler/infants with a history of seizures and/or encephalopathy.
- •7.Known thrombocytopenia or a bleeding disorder.
- •8.Known personal or maternal history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C seropositivity.
- •9.Planned surgery during the study.
- •10.Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
- •11.Toddlers/infants whose families are planning to leave the area of the study site before the end of the study period.
- •Specific to Part I (Toddler)
- •12.Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the trial vaccination or planned receipt of any non-study vaccine during the study period.
- •13.Known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy within 3 months prior to study entry
- •14.Receipt of blood or blood-derived products or immunoglobulins in the past 3 months, current or planned administration during the study period.
- •Specific to Part II (Infant)
- •12.Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) or Haemophilus Influenzae type b infection apart from trial vaccines during the study period.
- •13.Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination.
- •14.Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination.
- •15.Known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy prior to study entry
- •16.Receipt of blood or blood-derived products or immunoglobulins or planned administration during trial which might interfere with assessment of immune response.
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