CTRI/2023/09/057894进行中（未招募）4 期
A prospective multicentre Phase-IV study to evaluate the safety of Biological E’s14-valent pneumococcal polysaccharide conjugate vaccine when administered in6-10-14 weeks dosing schedule to 6-8 weeks old healthy Indian infants. - Nil
Biological ELimited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
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. Healthy pneumococcal conjugate vaccine-naïve (PCV-naive) infants as established by medical history and clinical assessment before entering into the study. PCV-naïve infants are those who have not been previously vaccinated
- •with any licensed or investigational pneumococcal vaccine (only for Safety arm).
- •2. Healthy pneumococcal conjugate vaccine-naïve (PCV-naive), Pentavalent vaccine (DTwP-rHepB-Hib) naïve, IPV vaccine naïve and live attenuated
- •Rotavirus vaccine naïve infants as established by medical history and clinical assessment before entering into the study. PCV/Pentavalent/IPV/Rotavirus vaccine-naïve infants are those who have not been previously vaccinated with any licensed or investigational PCV/Pentavalent/IPV/Rotavirus vaccines (only for immunogenicity arm).
- •3. Infants between 6-8 weeks of age (42-56 days, both days inclusive) of either gender, at the time of first dose of vaccination.
- •4. Healthy Infants with body weight = 3300 gms at the time of screening.
- •5. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone
- •contact, either residential landline or mobile).
- •6. Subject’s parent(s)/LAR(s) willing to provide written or thumb printed informed consent (including audio visual recording of consent process) prior to performing any study specific procedure.
- •7. Infants with a minimal vaccination status for their age at the time of enrolment
- •(minimal ? defined as single dose of only BCG, Hepatitis B &/or Polio vaccine prior to enrolment).
排除标准
- •1.Child in care
- •2.Evidence of previous Streptococcus pneumoniae infection or pneumococcal vaccination.
- •3.Evidence of previous or intercurrent or known exposure to diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus diseases (immunogenicity arm only)
- •4. Use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period other than the study vaccine.
- •5. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe (eg., coagulation abnormalities).
- •6. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- •7. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any
- •component of the study vaccines.
- •8. History of any neurological disorders, meningitis or seizures.
- •9. Infant who has had a sibling die of sudden infant death syndrome (SIDS) or die
- •suddenly and without apparent other cause or preceding illness in the first year of life.
- •10. Infant is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel).
- •11. Acute disease and/or fever at the time of vaccination.
- •o Fever is defined as the endogenous elevation of at least one measured
- •body temperature of = 38 ?C (= 100.4?F).
- •12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and Principal investigator judgement.
研究者
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