A multicentric, single blind, parallel, randomized, phase-IV non-inferiority study to evaluate the immunogenicity & safety of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy Indian infants at 6-10-14 weeks schedule in comparison with a marketed SIIL’s Pentavac SD™ vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 8
- 主要终点
- 1.Seroprotection rates (SPR) as defined by percentage of subjects with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres above their seroprotective cut off values.
研究概览
简要总结
A multicentric, single blind, parallel, randomized, phase-IV non-inferiority study to evaluate the immunogenicity & safety of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy Indian infants at 6-10-14 weeks schedule in comparison with a marketed SIIL’s Pentavac SD™ vaccine. This study to be conducted at 08 study sites.All the study sites will be located in xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India. There will be a total of 408 healthy subjects of either sex randomised into two groups in 2:1 ratio.
The primary outcome measure is to evaluate non-inferiority of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine with SIIL’s Pentavac SD™ in terms of difference in proportion of subjects achieving seroprotection with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres at day 84.
xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /The secondary outcome measures are to a) compare proportion of subjects achieving fold rise in anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres, above the seroprotection cut off value, between BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine and Pentavac SD™ at Day 84; b) To compare immunogenicity in terms of GMTs for anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres of BE’s combined pentavalent DTwP-rHepB-HIB vaccine with that of Pentavac SD™ at 84; c) To assess the safety and tolerability of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine in comparison with Pentavac SD™ for the entire study period of 84 days after the first vaccination.
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
- •Healthy infants between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) of either gender at the time of 1st vaccination.
- •Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian.
- •Healthy infants with weight equal to or more than 3300 gms at the time of screening.
- •Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary.
- •Infants or their mothers not participating in any other clinical trials.
- •Infants without contraindications or precautionary circumstances for participating in the trial Ability of the infants parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.
排除标准
- •Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral &/or Inactivated polio vaccine.
- •Current illness (especially fever) or any acute or congenital illness or disability.
- •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 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 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.Seroprotection rates (SPR) as defined by percentage of subjects with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres above their seroprotective cut off values.
时间窗: 1.At Day 84.
次要结局
- 1.Proportion of subjects achieving 4-fold rise in antibody titres.(2.Geometric mean titres(GMTs)estimation.)