PACTR202407771418605尚未招募2 期
A Phase 2/3 observer-blind, randomized, active-controlled study of the EuBiologics pentavalent meningococcal ACWYX conjugate vaccine (EuNmCV-5 Multi-dose) in healthy infants, toddlers, children, adolescents, and adults, to examine its safety, immunogenicity (including lot-to-lot consistency), and immunological non-inferiority when compared to MENVEO® or Nimenrix® as well as its non-interference with routinely co-administered vaccines
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 4,236
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
- 年龄范围
- 0 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1.Male or female participants with the age at time of study vaccination
- •2.Participant informed consent or assent and/or parent and/or legal guardian informed consent:
- •a.Children = 17 years of age: Signed or fingerprinted or personally marked written informed consent obtained from parent and/or legal guardian
- •b.Children = 12 years of age in The Gambia and = 13 years of age in Mali: Participant signed or fingerprinted or personally marked written informed assent
- •c.Adults = 18 years of age: Signed or fingerprinted or personally marked written informed consent
- •Note: Participants who turn 18 years of age during the study period, will be required to provide informed consent
- •3.Children who complete their local EPI schedule:
- •a.A birth dose of OPV is not required
- •b.Cohort 2: Through and including 9 months of age (no MenAfriVac® dose)
- •c.Cohort 4: Through and prior to 15 months of age (no MenAfriVac® dose and no 15+ months EPIs)
- •d.Cohort 5: Through and prior to 9 months of age (no MenAfriVac® dose and no 9+ months EPIs)
- •4.Healthy, as defined by the absence of any clinically significant medical conditions
- •5.Participant and/or parent and/or legal guardian of the participant resides in the study site area, with no intent to move out during the study period, and is able and willing to adhere to all protocol requirements
- •6.Participant must be either of non-childbearing potential or, if of childbearing potential, not breastfeeding and not pregnant and must have been practicing adequate contraception for = 2 months prior to study vaccination and agree to continue such precautions consistently through 2 months post study vaccination, as well as agree to not become pregnant through other means
- •7.Participant agrees not to enroll in another study of an investigational research agent
排除标准
- •1.Acute illness at the time of study vaccination
- •2.Recorded fever/use of an antipyretic medication within 48 hours prior to study vaccination
- •3.Cohorts 1 and 2:
- •a. Abnormal safety laboratory test value for age
- •b. Laboratory confirmed HIV, chronic hepatitis B virus infection, and/or hepatitis C virus infection
- •4.Current/previous N. meningitidis
- •5.Household contact/intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to Screening
- •6.Administration of systemic antibiotic treatment within 3 days of study vaccination
- •7.Administration of any vaccine other than the study vaccines within 28 days prior to/after study vaccination
- •8. Participation in another investigational product clinical study within 90 days prior to enrollment in this study/receipt of any such investigational product other than the study vaccines within 30 days prior to administration of study vaccines/planned use during study
- •9.Receipt of immunoglobulins and/or any blood products within 90 days prior to study vaccination/planned administration during study
- •10.Confirmed/suspected/family history immunodeficiency of congenital or hereditary immunodeficiency
- •11.Prior use of or anticipated need of long-acting immunomodulating drug/chronic administration of high dose systemic corticosteroids during study
- •12.History of severe adverse/allergic reaction to any vaccine or any components of the study vaccines
- •13.Participant is an employee/close personal relation of any person employed by the Sponsor, PATH, the CRO, the PI, key study site personnel
- •14.Planned surgery during the study period that would require hospitalization, use of prohibited medication, or will interfere with follow-up visits
- •15.History of known disturbance of coagulation/blood disorder
- •16.Medical/psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
- •17.Neurological disease/disorder
研究者
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