CTRI/2021/04/032693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 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
- •1. 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
- •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)
- •8. History of cytotoxic therapy, inhaled corticosteroids (not including allergic rhinitis corticosteroid spray treatment, acute uncomplicated dermatitis surfaces corticosteroid therapy)
- •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 Erbââ?¬•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
相似试验
进行中（未招募）
3 期
A clinical trial to know about effects of 15-valent pneumococcal conjugate vaccine in healthy infants given in a Reduced Dosing Schedule with Routine Pediatric Vaccinations.CTRI/2022/10/046401Tergene Biotech Pvt Ltd
进行中（未招募）
3 期
A Phase 3 Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (COVID-19)JPRN-jRCT2051210151agata Tsutae1,000
进行中（未招募）
3 期
A Booster Study of S-268023 (COVID-19)Prevention of COVID-19JPRN-jRCT2031230503Gomez Juan Carlos600
进行中（未招募）
3 期
A Booster Study of S-268019 in Participants Aged 5 to 11 Years (COVID-19)Prevention of COVID-19JPRN-jRCT2031220530Gomez Juan Carlos100
进行中（未招募）
1 期
A Phase 3 Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and OlderInfluenzaEUCTR2022-001638-12-PLModernaTX, Inc.23,000