A Phase III Multicentric Randomized Single Blind Study to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination Vaccine with Pentavac SD® Vaccine when Administered in Three Doses to 6-8 weeks old Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 10
- 主要终点
- •Proportion of subjects achieving seroconversion and seroprotection against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type B four to six weeks after three doses of primary immunization with HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine.
研究概览
简要总结
A Phase III Multicentric Randomized Single BlindStudy to Compare the Immunogenicity and Safety of HBI Pentavalent (DTwP-Hb-Hib[Liquid])Combination Vaccine with Pentavac SD® Vaccine when Administered inThree Doses to 6-8 Weeks Old Healthy Infants. The Primary objective is to determinethe Immunogenicity i.e. the humoral immune response of individual componentsi.e. Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib after vaccination withHBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine. The Secondary objectives are: To determine that theImmunogenicity (seroconversion and seroprotection rate) of HBI Pentavalent (DTwP-Hb-Hib[Liquid])Combination vaccine is not inferior to that of Pentavac SD® vaccine group and to compare among the groups the proportion of the subjects experiencinglocal and/or systemic reactions during follow up period. Blood samples will be collected before the administration of first dose of vaccination and 4 to 6 weeks after the 3rd dose of the vaccination. The samples will be sent to a central lab for analysis. The study will be conducted in ten centres across India.
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
- 1.50 Month(s) 至 2.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Healthy infants (as determined by medical history, physical examination and clinical judgement of the investigator) of either gender of 6-8 weeks of age at the time of first dose of vaccination.
- •2.Born after a normal gestational period (36 – 42 weeks) with a birth weight ≥ 2.5 kg.
- •3.Plans to remain in the study area for the duration of the trial.
- •4.Written informed consent for participation obtained prior to screening from subject’s parent/legally acceptable representative.
排除标准
- •1.Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
- •2.Planned participation in another clinical trial during the present trial period.
- •3.History of immunization with any vaccine other than birth dose Polio, BCG and birth dose of Hepatitis B vaccines.
- •4.Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination except OPV.
- •5.Evidence of previous infection with Diphtheria, Tetanus, Pertussis, Hepatitis B and H.
- •influenzae.
- •6.History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics.
- •7.Known personal or maternal history of HIV or hepatitis B seropositivity.
- •8.Infants having any intercurrent illness.
- •9.History of fever with temperature > 380C (>100.40F) in last 3 days.
- •10.Known or suspected primary or acquired disease of the immune system.
- •11.Known or suspected malignancy, receipt of allergy immunotherapy, or immunosuppressive therapy.
- •12.History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
- •13.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
- •14.Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial period.
- •15.Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs.
- •16.Any history or evidence of thrombocytopenia or a bleeding disorder or receipt of anticoagulants.
- •17.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
结局指标
主要结局
•Proportion of subjects achieving seroconversion and seroprotection against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type B four to six weeks after three doses of primary immunization with HBI Pentavalent (DTwP-Hb-Hib[Liquid]) Combination vaccine.
时间窗: Till 4 to 6 weeks post 3rd dose of vaccination
次要结局
- Till 4 to 6 weeks post 3rd dose of vaccination.(Till 4 to 6 weeks post 3rd dose of vaccination)