CTRI/2018/12/016692已完成3 期
Phase III Safety and Immunogenicity of an Investigational versus the Licensed Formulation of the Pentavalent Vaccine (DTwP-HepB-Hib) SHAN 5® when administered as Three Dose Primary Series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants and Safety and Immunogenicity of the Investigational SHAN 5® Formulation when administered as a Single Booster Dose at 12-24 Months of Age
Shantha Biotechnics Pvt Ltd10 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2018年12月28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
- 460
- 试验地点
- 10
- 主要终点
- Immunogenicity in terms of Hep B seroprotection rate and pertussis immune responses
研究概览
简要总结
This will be a multi-center, randomized, active controlled, two arm, observer blind study in 460 infants followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed vaccine formulation of SHAN 5® at 6-8, 10-12 and 14-16 weeks of age. Followed by single arm, open label study in the subjects upon attaining 12-24 months of age followed up for safety and immunogenicity for 28 days after administration of single booster dose of the investigational vaccine formulation of SHAN 5®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 42.00 Day(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •For Infants (Stage 1): 1.Infants between 6-8 weeks of age on the day of enrollment.
- •2.Healthy infants, born at full term of pregnancy (not less than 37 weeks) with a birth weight not less than 2.5 kg 3.Informed consent form signed by the parent or by the legally acceptable representative (LAR).
- •4.Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
- •For Toddlers (Stage 2): 1.Toddlers aged between 12-24 months of age on the day of enrollment and had received either the investigational or the licensed SHAN 5® vaccine formulation at 6-8, 10-12 and 14-16 weeks of age during stage 1 of the trial.
- •2.Informed consent form signed by the parent or by the LAR.
排除标准
- •Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period 2.Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
- •3.Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV.
- •4.For Stage 1 only: Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- •5.For Stage 2 only: Previous booster dose vaccination against diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- •6.Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial.
- •7.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, or long-term systemic corticosteroid therapy.
- •8.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections.
- •9.Known personal or maternal history of HIV or hepatitis B seropositivity.
- •10.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.
- •11.Known thrombocytopenia.
- •12.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
- •13.Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- •14.Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness on the day of inclusion.
- •15.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
- •16.Subject with definite seizure disorder and getting anticonvulsant therapy.
结局指标
主要结局
Immunogenicity in terms of Hep B seroprotection rate and pertussis immune responses
时间窗: Baseline; 28 days after Dose-3 in infants
次要结局
- Immunogenicity in terms of Seroprotection/seroresponse rates/GMCs for D,T,wP,HepB and Hib antigens(Baseline; 28 days post Dose-3 in infants and 28 days after single dose in toddlers)
- Safety after each and after any study vaccine dose, as applicable.(Immediate adverse events within 30 min, Solicited reactions within 7 days and Unsolicited Events within 28 days of vaccination.)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
Phase 3 Boosting Study for the SARS-CoV-2 rS Variant VaccinesCOVID-19SARS CoV 2 InfectionNCT05372588Novavax1,340
已完成
3 期
Study of Immunogenicity, Reactogenicity and Safety of the Combined Measles, Mumps and Rubella Vaccine Produced by Bio-Manguinhos/Fiocruz in Children 12-15 Months of Age, Followed by Tetraviral Vaccine in Children 15-18 Months.MeaslesMumpsVaricellaRubellaNCT01991899The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)1,560
已完成
3 期
Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and ElderlyInfluenzaNCT00306527Novartis Vaccines2,235
尚未招募
3 期
Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration in Adults Aged 18 to 59 Years.ChikungunyaNCT06973772Butantan Institute900
已完成
3 期
Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 YearsInfluenzaNCT00616928GlaxoSmithKline4,561