CTRI/2021/10/037067已完成3 期
A single blind randomised active-controlled Phase-III study to evaluate safety and immunogenicity of a candidate 14-valent pneumococcal polysaccharide conjugate vaccine administered to 6-8 weeks old healthy Indian Infants in 6-10-14 weeks dosing schedule. - None
Biological ELimited0 个研究点目标入组 300 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
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.
- •2. Infants between 6-8 weeks of age (42-56 days, both days inclusive) of either gender, at the time of 1st dose of vaccination.
- •3. Healthy Infants with weight = 3300 gms at the time of screening.
- •4. 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).
- •5. 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
- •6. Infants with a minimal vaccination status for their age at the time of enrolment (minimal ? defined as single dose of BCG, Hepatitis B &/or Polio vaccine at the time of enrolment).
排除标准
- •1. Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
- •2. Evidence of previous Streptococcus pneumoniae infection or pneumococcal vaccination.
- •3. 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.
- •4. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe (eg., coagulation abnormalities).
- •5. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs or any blood products during the period starting 30 days prior to the proposed first vaccine dose or planned administration of the same during the study period.
- •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. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •8. Family history of congenital or hereditary immunodeficiency.
- •9. 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.
- •10. History of any neurological disorders, meningitis or seizures.
- •11. 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.
- •12. 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).
- •13. Acute disease and/or fever at the time of vaccination.
- •Fever is defined as the endogenous elevation of at least one measured body temperature of = 38?C (= 100.4?F).
- •14. 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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