A multicentric double blind single arm randomised phase-IV study to evaluate the safety, reactogenicity & lot consistency of three production lots of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered at 6-10-14 weeks schedule to 6-8 week old healthy Indian infants.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 10
- 主要终点
- 1.Solicited local and systemic adverse events (AEs).
研究概览
简要总结
A multicentric double blind single arm randomised phase-IV study to evaluate the safety, reactogenicity & lot consistency of three production lots of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered at 6-10-14 weeks schedule to 6-8 week old healthy Indian infants at 10 study sites.
All the study sites will be located within xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India. There will be a total of 660 healthy infants of either sex in the age group of 6-8 weeks. A 3-dose vaccination schedule at 6-10-14 weeks of age as per WHO-EPI guidelines will be followed in all the three lot groups
The primary outcome measure is to evaluate safety and reactogenicity of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine up to 28 days after the 3rd dose of the primary immunisation schedule of 6-10-14 weeks .
The secondary outcomes will be to a) evaluate the equivalence between the three production lots in terms of geometric mean titre ratio against Diphtheria, Pertussis, Tetanus, HBsAg and PRP-T antigens at day 84 (28 days after 3rd dose); b) compare the immunogenicity between three production lots in terms of proportion of subjects achieving seroprotection with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres at day 84 (28 days after 3rd dose); c) compare proportion of subjects achieving fold rise in anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP-T antibody titres, above the sero-protection cut off value, at Day 84 (28 days after 3rd dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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, 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 1st vaccination.
- •Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature).
- •Healthy infants born to mothers sero-negative to HIV, HBV and HCV as confirmed by blood tests on the mother or based on maternity discharge summary.
- •Subjects or their mothers not participating in any other clinical trials.
- •Infants without contraindications or precautionary circumstances for participating in the trial.
- •Ability of the subjects 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/injectable 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.Solicited local and systemic adverse events (AEs).
时间窗: 1.During first 60 minutes of vaccine administration at each dose. | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period up to 28th day. | 4.Until 84 days after the first vaccination. | 5.At each visit.
2.Solicited local and systemic adverse events (AEs).
时间窗: 1.During first 60 minutes of vaccine administration at each dose. | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period up to 28th day. | 4.Until 84 days after the first vaccination. | 5.At each visit.
3.Solicited and unsolicited adverse events (AEs).
时间窗: 1.During first 60 minutes of vaccine administration at each dose. | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period up to 28th day. | 4.Until 84 days after the first vaccination. | 5.At each visit.
4.Rate of SAEs and medically attended AEs.
时间窗: 1.During first 60 minutes of vaccine administration at each dose. | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period up to 28th day. | 4.Until 84 days after the first vaccination. | 5.At each visit.
5.Vital signs (Pulse, axillary body temperature and Respiratory rate).
时间窗: 1.During first 60 minutes of vaccine administration at each dose. | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period up to 28th day. | 4.Until 84 days after the first vaccination. | 5.At each visit.
次要结局
- 1.Geometric mean titres(GMTs) estimation.(2.Seroprotection rates (SPR) as defined by percentage of subjects with Anti D,T,wP,rHepB,Hib above their respective cut off values.)