A prospective randomised active controlled Phase-II safety and immunogenicity study with 3-doses of Biological E’s Liquid Hexavalent Vaccine (DTwP-rHepB-Hib-IPV) in 6-8 weeks old infants.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- 1.Solicited local adverse reactions and systemic events
研究概览
简要总结
This is a phase II, prospective, open label randomized study assessing safety and immunogenicity of BE’s Liquid Hexavalent Vaccine (DTwP-rHepB-Hib-IPV) compared with a licensed comparator.
A total of 180 healthy 6-8 weeks old infants will be enrolled into the study based on recruitment criteria set.
The study will be conducted in compliance with GSR 227(E), 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
- Randomized
- 盲法
- None
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, 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).
- •Subjects and or their mothers not participating in any other clinical trials.
- •Infants without contraindications or precautionary circumstances for participating in the trial.
- •Ability of the subject’s parent or legally acceptable representative or guardian to understand and comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
排除标准
- •Child in care
- •Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of birth dose BCG, Hepatitis B & oral polio vaccine.
- •Co-administration of any oral or injectable polio vaccine during the course of the study.
- •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.
- •Known or suspected allergy to any of the vaccine components.
- •Any sign or symptom or 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.
- •Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
- •Subjects and or their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
- •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.
- •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
1.Solicited local adverse reactions and systemic events
时间窗: 1. during first 60 minutes of vaccine administration after each dose | 2.during 7-day (Day 0-6) post vaccination period | 3.during the subsequent follow up period i.e., 28 days after each dose | 4.for the total study period.
2.Solicited local and systemic adverse events (AEs)
时间窗: 1. during first 60 minutes of vaccine administration after each dose | 2.during 7-day (Day 0-6) post vaccination period | 3.during the subsequent follow up period i.e., 28 days after each dose | 4.for the total study period.
3.Unsolicited adverse events (AEs)
时间窗: 1. during first 60 minutes of vaccine administration after each dose | 2.during 7-day (Day 0-6) post vaccination period | 3.during the subsequent follow up period i.e., 28 days after each dose | 4.for the total study period.
4.Rate of SAEs, medically attended AEs and AEs of special interest (AESI)
时间窗: 1. during first 60 minutes of vaccine administration after each dose | 2.during 7-day (Day 0-6) post vaccination period | 3.during the subsequent follow up period i.e., 28 days after each dose | 4.for the total study period.
次要结局
- Proportion of subjects seroconverted and or seroprotected with anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP-T and serotype specific anti-Polio antibodies(At Day 84 (28 days’ post 3rd dose).)
- Geometric mean concentrations titres (GMC Ts) for anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titres(At baseline and again at Day 84 (28 days’ post 3rd dose) from baseline (day 0).)
- Proportion of subjects achieving ≥2-fold and ≥4-fold rise in anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titres(At Day 84 (28 days’ post 3rd dose) from baseline (day 0))
- Geometric mean fold rise (GMFR) for anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titres(At Day 84 (28 days’ post 3rd dose) from baseline (day 0).)
研究者
Dr Subhash Thuluva
Biological E.Limited