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.
LG Life Sciences Ltd8 个研究点 分布在 1 个国家目标入组 492 人开始时间: 2009年2月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 492
- 试验地点
- 8
- 主要终点
- Comparison of immunogenicity as measured by seroprotection /vaccine response rates through evaluation of anti-HBs, anti-diphtheria, anti-tetanus, anti-pertussis antibodies at four weeks post final immunization in the LBVW0101 and Active Comparator (Combined DTPw-HB Vaccine) groups
研究概览
简要总结
This is a prospective, multicentre, comparative, parallel, double-blind, randomised phase III study to assess immunogenicity and safety of LBVW0101 (Combined DTwP-HB vaccine) compared with Active Comparator Tritanrix-HB (Combined DTPw-HB Vaccine) and to demonstrate the equivalence of three different lots of LBVW0101, in terms of immunogenicity, in healthy 492 subjects. (infants at six, ten and fourteen weeks of age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •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
- •Born at full term of pregnancy
- •Body weight more than 3.2kg at enrollment
- •Born to HBsAg negative mother
- •Not previously received any dose of HB and DTP
- •Able to comply with visit schedule
- •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:
- •History of previous or concurrent vaccinations other than Bacillus Calmette-Guerin (BCG) or Oral Polio Vaccine (OPV) at birth.
- •Known or suspected disease history of hepatitis B, diphtheria, pertussis, or tetanus.
- •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.
- •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 pertussis.6.Experienced fever ≥37.5°C/ 99.5°F within the past three days.
- •Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days.
- •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.
- •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.
- •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.
- •Infants whose families are planning to leave the area of the study site before the end of the study period.
结局指标
主要结局
Comparison of immunogenicity as measured by seroprotection /vaccine response rates through evaluation of anti-HBs, anti-diphtheria, anti-tetanus, anti-pertussis antibodies at four weeks post final immunization in the LBVW0101 and Active Comparator (Combined DTPw-HB Vaccine) groups
时间窗: At the end of four weeks | (Post- Vaccination)
次要结局
- A. Seroprotection/vaccine response rates in the three lots B.GMTs C. incidence of solicited local reactions,systemic events and unsolicited events respectively.(At the end of four weeks)
研究者
研究点 (8)
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