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. - NA
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects will be considered eligible for the study based on the following criteria:
- •1. Able to follow all the study requirements and voluntarily obtained informed consent from Parent/legal guardian/ LAR of the infant
- •2. Infant aged 6-10 weeks (42-69 days) at enrollment
- •3. Healthy infant as determined by medical history, physical exam, and judgment of the investigator
- •4. 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:
- •1. Subject with administration history of pneumococcal vaccine
- •2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis or rotavirus vaccines
- •3. Known hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component
- •4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, rotavirus or pneumococcal vaccines
- •5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
- •6. Known or suspected immune deficiency or suppression
- •7. Receipt of blood or gamma-globulin products (including hepatitis B immunoglobulin and monoclonal antibodies). Local anesthetic cream may be applied before blood draws.
- •8. 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 PIâ??s discretion.
- •9. History of culture-proven invasive disease caused by S. pneumoniae or H. influenzae type b (Hib)
- •10. Any congenital malformation, developmental disorder, genetic defects or severe malnutrition
- •11. 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 Erbâ??s palsy.
- •12. Participation in another investigational trial. Participation in purely observational studies is acceptable.
- •13. Any co-existing condition which in the opinion of investigator may interfere with the study participation
- •14. Direct descendant (i.e. child, grandchild) of study site personnel
- •15. Infants with known Coronavirus infection (COVID-19)
研究者
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