A Randomized, Comparative, Open Labeled, Multicentric, Phase I Study To Evaluate And Compare The Safety, Tolerability And Immunogenicity Of Two Formulations (With And Without Preservative) Of 10-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Nucovac® Of Panacea Biotec Ltd. With Synflorix® Of Glaxosmithkline Ltd. In Healthy Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Incidence, intensity, causality and relationship to vaccination of solicited reactions (local and
研究概览
简要总结
This study will be conducted as a randomized, open label, comparative, phase I study. The enrolled subjects will be randomly allocated in a ratio of 1:1:1 to one of the three study arm A, Arm B and Arm C (24 subjects per arm including anticipated 20% dropout rate). Enrolled and randomized subjects will receive treatment (vaccination). Infants 6-10 weeks of age will be Screened, Enrolled and Randomized to one of the three study arms (A, B and C), upon receipt of written informed consent from Parents/LAR. Subjects will receive 3-dose of one the study vaccines (NUCOVAC® with or without preservative or SYNFLORIX®) based on randomization at 0, 4, 8 weeks of enrollment. The vaccines will be administered by a deep intramuscular route in the antero-lateral aspect of right thigh. Subjects will be observed after vaccination at site for Solicited local and systemic reactions for 6 hours after vaccination and for the next 7 days through diary card. Adverse events will also be monitored for 28 days after each vaccination. Blood samples will be obtained from subjects at visit 1(before first vaccination) and at visit 4 (Follow up visit, 4 weeks after the third vaccine dose) for estimation of lab safety parameters and neutralizing antibodies against pneumococcal polysaccharide. Safety analysis will be done at study site laboratory while immunogenicity analysis will be done at central lab, Mohali. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 42.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Infants 6-10 weeks of age, whose parents/LAR willing to give written informed consent prior to the study entry.
- •2.Infants with good health as determined by: • Medical history • Physical examination • Clinical judgment of the investigator 3.Subjects judged to be able to attend all scheduled study visits and to comply with trial procedures.
排除标准
- •1.History of previous vaccination against S.
- •pneumonia 2.History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) 3.Infants expected to receive any vaccine other than the EPI schedule.
- •4.Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
- •5.Known HBsAg positivity in mother.
- •6.Infants less than 6 weeks or more than 10 weeks of age.
- •7.Infants weighing less than 3.3 Kg at the time of enrollment.
- •8.Known Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine with similar composition.
- •9.Known history of administration of blood or blood-derived products 10.Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulin, immunosuppressant or other immune-modifying drugs in past or at any time during the study.
- •11.Febrile illness (temperature ≥38.0°C or 100.4 °F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
- •12.Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
- •13.Infants who have participated in another trial or received an investigational agent within 30 days of enrolment.
- •Infants with any clinically significant disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or autoimmune disease under treatment) or major congenital defects, such that it would endanger the infant’s well-being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •15.History or presence of significant asthma, urticaria or other allergic reactions.
- •16.Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity 17.Planned participation in another clinical trial during the trial period.
- •18.Subject’s Parents/LAR planning to leave the area of study before completion of the study.
结局指标
主要结局
Incidence, intensity, causality and relationship to vaccination of solicited reactions (local and
时间窗: Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. | Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. | Serious Adverse Events (SAEs) during the entire study period
systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each
时间窗: Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. | Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. | Serious Adverse Events (SAEs) during the entire study period
vaccination.
时间窗: Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. | Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. | Serious Adverse Events (SAEs) during the entire study period
(including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination.
时间窗: Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. | Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. | Serious Adverse Events (SAEs) during the entire study period
Incidence, intensity, causality and relationship to vaccination of unsolicited adverse events
时间窗: Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. | Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. | Serious Adverse Events (SAEs) during the entire study period
Serious Adverse Events (SAEs) during the entire study period
时间窗: Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. | Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. | Serious Adverse Events (SAEs) during the entire study period
次要结局
- Primary analysis Proportion of subjects achieving seroprotection(against Pneumococcal Serotypes)