CTRI/2022/10/046401进行中（未招募）3 期
A Phase 3, Observer blind, Randomized, Active-Controlled Trial Evaluating the Immunologic Non-inferiority, Safety and Tolerability of a 15-valent Pneumococcal Conjugate Vaccine Compared to a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given in a Reduced Dosing Schedule with Routine Pediatric Vaccinations.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- serotype-specific IgG GMC ratio
研究概览
简要总结
This is a Phase 3, Observer blind, Randomized, Active-Controlled Trial Evaluating the Immunologic Non-inferiority, Safety and Tolerability of a 15-valent Pneumococcal Conjugate Vaccine Compared to a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given in a Reduced Dosing Schedule with Routine Pediatric Vaccinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 42.00 Day(s) 至 69.00 Day(s)（—）
- 性别
- All
入选标准
- •Subjects will be considered eligible for the study based on the following criteria:
- •Able to follow all the study requirements and voluntarily obtained informed consent from Parent/legal guardian/ LAR of the infant
- •Infant aged 6-10 weeks (42-69 days) at enrollment
- •Healthy infant as determined by medical history, physical exam, and judgment of the investigator
- •Parent/ legal guardian/ LAR must be able to complete all relevant study procedures during study participation.
排除标准
- •Subjects will be excluded from the study based on the following criteria:
- •Subject with administration history of pneumococcal vaccine
- •Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis or rotavirus vaccines
- •Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, rotavirus or pneumococcal vaccines
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
- •Known or suspected immune deficiency or suppression
- •Receipt of blood or gamma-globulin products (including hepatitis B immunoglobulin and monoclonal antibodies).
- •Local anesthetic cream may be applied before blood draws.
- •History of cytotoxic therapy, inhaled corticosteroids (not including allergic rhinitis corticosteroid spray treatment, acute uncomplicated dermatitis surfaces corticosteroid therapy).
- •Topical and inhaled corticosteroids may be permitted as per PI’s discretion.
- •pneumoniae or H.
- •influenzae type b (Hib)
- •Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
- •Does not include resolving syndromes due to birth trauma such as Erb’s palsy.
- •Participation in another investigational trial.
- •Participation in purely observational studies is acceptable.
- •Any co-existing condition which in the opinion of investigator may interfere with the study participation
- •Direct descendant (i.e. child, grandchild) of study site personnel
- •Infants with known Coronavirus infection (COVID-19).
结局指标
主要结局
serotype-specific IgG GMC ratio
时间窗: 28 days after completion of 2nd Dose
Percentage of subjects achieving WHO-predefined serotype-specific antibody threshold (Greater than or equal to 0.35 microgram per ml).
时间窗: 28 days after completion of 2nd Dose
次要结局
- Ratio of the post-booster value to the post-primary value for the IgG GMCs,(Serotype-specific Reverse Cumulative Distribution (RCD) plots for IgG.)
研究者
研究点 (5)
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