CTRI/2025/04/085479招募中3 期
A prospective, single blind, randomised, active controlled Phase-III study to assess the immunogenicity and safety of Biological E’s Liquid Hexavalent Vaccine (DTwP-rHepB-Hib-IPV) in 6-8 weeks old healthy infants in a 6-10-14 weeks dosing schedule.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,012
- 试验地点
- 48
- 主要终点
- The proportion of subjects sero-protected for anti-Diphtheria, anti-Tetanus, anti-PRP-T, anti-HBsAg, serotype-specific anti-Polio antibodies, and seroconverted for anti-Pertussis
研究概览
简要总结
This is a prospective, single blind, randomized, active-controlled, phase-III study to evaluate immunogenicity and safety of Biological E’s Liquid Hexavalent Vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.
The target population for this study would be 6-8 weeks old healthy infants of either gender, at the time of first dose administration. The total sample size to be enrolled would be 4012 healthy eligible subjects.
The study will be conducted in compliance with NDCT Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant 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
- •Intended subjects will be healthy infants between 6-8 weeks of age (42-56 days, both inclusive), of either gender at the time of 1st vaccination.
- •Written or thumb printed informed consent obtained from the subject’s parent(s) or legally acceptable representative prior to performing any study specific procedure.
- •Healthy infants with weight 3300gms at the time of 1st vaccination.
- •Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the investigator.
- •Infants without contraindications or precautionary circumstances for participating in the trial.
排除标准
- •Child in care
- •Prior immunization and co-administration of any OPV or IPV, DTP, Hepatitis-B or Hib vaccine with the exception of birth dose BCG, Hepatitis B and OPV.
- •Current illness (especially fever) or any acute or congenital illness or disability.
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or H.
- •influenzae type b diseases
- •Subjects receiving immunosuppressive therapy.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Known or suspected allergy to any of the vaccine components.
- •History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •Any sign or symptom of systemic dysfunction, especially of the central nervous system (CNS).
- •Known family history of SIDS (Sudden Infant Death Syndrome).
- •Planned or elective surgery during the course of the study.
- •Subjects and / or their mothers who have participated / are participating in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
- •Inability or unwillingness to abide by the requirements of the protocol.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Infant is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel).
- •Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
结局指标
主要结局
The proportion of subjects sero-protected for anti-Diphtheria, anti-Tetanus, anti-PRP-T, anti-HBsAg, serotype-specific anti-Polio antibodies, and seroconverted for anti-Pertussis
时间窗: At Day 84 (28 days post-third dose)
次要结局
- Proportion of subjects with unsolicited adverse events (AEs)(during the 28 day follow up period after each dose of vaccination)
- Proportion of subjects with solicited local adverse reactions and systemic events(during the first 30 minutes following vaccine administration after each dose)
- Proportion of subjects with solicited local and systemic adverse events (AEs)(during the 7-day (Day 0-6) post vaccination period)
- Proportion of subjects with occurrence, severity and causality of all the reported adverse events(28 days after each dose.)
- Number and proportion of subjects seroconverted in terms of serum IgG concentrations induced by 14 serotypes of BE-PCV14 and serum IgA concentrations induced by Rotavirus vaccine in both BE’s LHV and licensed comparator vaccinated subjects.(At day 84)
- Rate of serious adverse events (SAEs) and medically attended AEs(for the total study period.)
- Proportion of subjects with SAEs(during the 6 months follow up period after the third dose of the vaccination)
- Geometric mean concentrations/titres (GMC/Ts) and GMFR for anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations/titres(Both at baseline and again at Day 84)
- Geometric mean concentrations/titres for anti-diphtheria, anti-tetanus, anti-pertussis, anti-hepatitis B, anti-haemophilus influenzae type b and anti-polio serotypes 1, 2 & 3, estimated in all three lots of BE’s LHV(at baseline and again at Day 84)
研究者
研究点 (48)
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