CTRI/2009/091/000394已完成3 期
A prospective, multicentre, comparative, double blind, randomized phase III study to assess immunogenicity and safety of LBVW0101 (Diphtheria-Tetanus-whole cell Pertussis- Hepatitis B) compared with Tritanrix HB® (Diphtheria-Tetanus-whole cell Pertussis-Hepatitis B) and to demonstrate the equivalence of three different lots of LBVW0101, in terms of immunogenicity, in healthy infants at six, ten, and fourteen weeks of age.
G Life Sciences Ltd0 个研究点目标入组 492 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 492
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. Healthy infants of either sex who have reached at least 42
- •days of age and not more than 56 days of age at the time of enrollment
- •2. Born at full term of pregnancy 3. Body weight more than 3.2kg at enrollment
- •4. Born to HBsAg negative mother
- •5. Not previously received any dose of HB and DTP
- •6. Able to comply with visit schedule
- •7. Signed informed consent by subject Legally Acceptable
- •Representative
排除标准
- •Subjects are not eligible for enrollment if any of the following criteria are met:
- •1. History of previous or concurrent vaccinations other than
- •Bacillus Calmette-Guerin (BCG) or Oral Polio Vaccine (OPV) at
- •2. Known or suspected disease history of hepatitis B, diphtheria,
- •pertussis, or tetanus.
- •3. Planned administration of a vaccine not foreseen by the study
- •protocol, with the exception of OPV, Hib or BCG vaccine (if not
- •administered at birth), which may be administered during the
- •course of study according to local Expanded Programme on
- •Immunization (EPI) schedule.
- •4. LAR is unwilling or unable to give written informed consent to
- •participate in the study.
- •5.Household contact and/or intimate exposure in the previous 30
- •days to an individual with ascertained HB, diphtheria or
- •6.Experienced fever ≥37.5°C/ 99.5°F within the past
- •three days.
- •7. Experienced significant acute or chronic infections requiring
- •systemic antibiotic treatment or antiviral therapy within the
- •past 7 days.
- •8. Known or suspected impairment of the immune function,
- •receiving immunosuppressive therapy, or having received
- •immunosuppressive therapy within 30 days prior to study
- •entry (ex. systemic corticosteroid). However, treatment with
- •corticosteroids (prednisolone equivalent≤0.5
- •mg/kg/day) not more than 14 consecutive days prior to those
- •30 days will not be an exclusion criterion.
- •9. Received a parenteral immunoglobulin preparation and/or
- •blood product since birth.
- •10.History of allergy considered due to any vaccine component,
- •including excipients and preservatives.
- •11. Evidence of significant haematological, cardiac, hepatic, renal,
- •neurological, respiratory, metabolic disease or any condition
- •which, in the opinion of the Investigator, might interfere with
- •the evaluation of the study objectives.
- •12 Participation in another trial or received any investigational
- •product 30 days prior to enrollment or simultaneous
- •participation in another clinical study.
- •13. Infants whose families are planning to leave the area of the
- •study site before the end of the study period.
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