An Open Labeled, Single Arm (Non-Comparative), Prospective Phase I Clinical Study To Evaluate The Safety, Tolerability And Immunogenicity Of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 11-Valent Of Panacea Biotec Ltd. In Healthy 12-23 Months Old PCV- naïve Toddlers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 3. Incidence, intensity and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period.
研究概览
简要总结
This is an open label phase I study to demonstrate safety, tolerability and immunogenicity of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 11 valent. After obtaining the informed consent from the subject’ parent or LAR, followed by preliminary screening as per inclusion and exclusion criteria a total of 30 healthy PCV-naïve toddlers (in the age group of 12-23 months) will be enrolled into the study. Enrolled subjects will receive intramuscularly 0.5 ml of test vaccine.
There will be a total of 3 visits during the entire study duration. For all subjects, the study period will be divided into 3 visits: Day 0 (Visit 1), Day 60 (Visit 2) and Day 90 (Visit 3). Subject will receive two doses of vaccine with a 60 day (-3/+7) interval between doses. Local and systemic solicited reactions will be observed on each vaccination day (up to 30 minutes post vaccination) and on 7 subsequent days (day 0-6) post vaccination. Local & systemic solicited reactions will be recorded in subject diary card. Adverse events will be monitored during the total study period of 90 days. Blood samples (For immunogenicity assessment) will be obtained from subjects at visit 1(before first vaccination) and at visit 3 (Day 90; Follow up visit).
The study will be conducted according to schedule Y, declaration of Helsinki and Good Clinical Practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Month(s) 至 23.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Healthy PCV-naïve toddler between 12-23 months of age (Both Inclusive) on the day of enrollment.
- •PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
- •3.Toddlers with an up-to-date minimal vaccination status for their age at the time of enrollment (“minimalâ€defined as single dose of BCG, 3 doses of Polio vaccine, DPT, Hepatitis B and single dose of Measles at the time of enrollment).
- •4.Toddlers with good health as determined by: 4.1 Medical history 4.2 Physical examination 4.3 Clinical judgment of the investigator 5.Toddlers judged to be able to attend all scheduled study visits and to comply with trial procedures.
排除标准
- •1.History of culture-proven invasive disease caused by S.
- •pneumoniae.
- •2.Toddler who have received any pneumococcal vaccine prior to enrollment.
- •3.History of Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C in toddler.
- •4.Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drug within the 6 months prior to administration of the study vaccine.
- •For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day or equivalent.
- •5.Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period.
- •6.Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- •7.History of any neurological disorder, meningitis or seizures.
- •8.Axillary temperature ≥ 38.0°C in past 3 days.
- •9.Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 30 days before the administration of study vaccine or planned use during the study period.
- •11.Toddler with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •12.Toddler with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives or compromise the safety of the subject.
- •13.The parents or LAR are unwilling or unable to give written informed consent to participate in the study 14.Toddlers whose families are planning to leave the area of the study site before the end of the study period.
- •15.Todllers who have participated in another trial or received an investigational agent within 30 days of enrolment.
- •Exclusion criteria for the second dose 1.Hypersensitivity to vaccine within 48 hours of administration of previous vaccine dose 2.Seizures 3.Encephalopathy 4.Axillary temperature of > 40oC within 48 hours of previous vaccine dose 5.Inconsolable persisting crying (defined as > 3 hours within 48 hours of previous vaccination), 6.Generalized cyanosis within 48 hours of previous vaccine dose 7.Any serious reaction after previous dose which can compromise the safety of the subject if continued in the trial.
结局指标
主要结局
3. Incidence, intensity and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period.
时间窗: 1. During the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination | 2. During the entire study period. | 3. During the entire study period.
1. Incidence, intensity and relationship to vaccination of solicited(local and systemic ) adverse reactions during the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination
时间窗: 1. During the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination | 2. During the entire study period. | 3. During the entire study period.
2. Incidence, intensity and relationship to vaccination of unsolicited adverse reactions during the entire study period.
时间窗: 1. During the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination | 2. During the entire study period. | 3. During the entire study period.
次要结局
- 1. Proportion of subjects with anti-pneumococcal polysaccharide conjugate (PnCPS) IgG antibody concentration 0.35 μg/ml (as measured by ELISA) against each of the vaccine serotypes at day 30 post 2nd dose of test vaccine.(2. Anti-PnCPS IgG ELISA geometric mean titre (GMT) against each of the vaccine serotypes with their two sided 95% Cls at day 30 post 2nd dose of test vaccine.)