CTRI/2012/08/002872进行中（未招募）3 期
Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5 (DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD When Administered as a Single Booster Dose at 15-18 months and Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Children and Infants.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
- 试验地点
- 11
- 主要终点
- Seroprotection/ Seroresponse rates to five antigens for immunogenicity
研究概览
简要总结
This clinical study will assess theimmunogenicity and safety of Shantha’s DTPwHB-HIB (Shan 5 TM)combined vaccine against comparatorsvaccine given simultaneously to different groups as a singlebooster dose at 15-18 months and three-dose primary vaccination at 6-8,10-12,and 14-16 weeks of age subjects.
Studywill evaluate equivalence of immunogenicity of three lots of Shan 5 and itsnon-inferiority to comparator vaccine in terms of seroprotection/ seroresponse ratesto all antigens one month after a three-dose primary series (6-8, 10-12 and14-16 weeks).
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 18.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Children between the age of 15-18 months whose parents/LAR is willing to give written informed consent prior to the study inclusion.
- •3.Children who have completed primary immunization series of diphtheria, tetanus, pertussis by virtue of previous immunization and have not received the booster dose scheduled at 15-18 months of age.
- •4.Children who require a dose of Hepatitis B as per National Immunization schedule/IAP recommendation because of one of the following reasons: i)Has not received any dose of Hepatitis B or ii)Have not completed primary vaccination against Hepatitis B 5.Children who require a dose of Haemophilus influenzae type b as per National Immunization schedule/IAP recommendation because of one of the following reasons: i)Has not received any dose of Hib or ii)Completed primary vaccination against Hib but not received the booster dose.
- •6.Judged to be able to attend all scheduled study visits and to comply with study procedures.
- •Infants between 6-8 weeks of age on the day of inclusion
- •Born at full term of pregnancy (≥37 weeks) with a birth weight ≥2.5 kg.
- •Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •1.Participation in another clinical trial in the 4 weeks preceding the first trial vaccination 2.Planned participation in another clinical trial during the present trial period 3.Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroids therapy(prednisone or equivalent at ≥ 0.5 mg/kg/day) for more than 2 consecutive weeks within the past 2 months) 4.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.(The list of vaccines components is included in the investigator’s brochure) 5.Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator (Chronic illness may include, but is not limited to, haematological, hepatic, renal, cardiac or respiratory disease or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, or encephalopathy etc.) 6.Blood or blood-derived products received in the past (since birth) or current or planned administration during the trial (including immunoglobulins) that might interfere with the assessment of the immune response 7.Any vaccination before trial vaccination except OPV, HepB and BCG given at birth.
- •(Cohort 2 only) 8.Any planned vaccination until one month after the last trial vaccination except; (i)OPV during National Immunization Days (For both the Cohorts), (ii)BCG if not given at birth (Cohort 2 only).
- •9.Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) 10.Previous vaccination against pertussis, tetanus, diphtheria or Haemophilus influenzae type b infections (Cohort 2 only) 11.Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity.
- •12.Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating IM vaccination 13.History of seizures 14.Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.
结局指标
主要结局
Seroprotection/ Seroresponse rates to five antigens for immunogenicity
时间窗: one month after vaccination
次要结局
- Safety of the vaccines(One month and six months after vaccination)
研究者
研究点 (11)
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