Immunogenicity, molecular profiling and safety of a marketed Quadrivalent Influenza Vaccine (FluQuadriTM) administered by the intramuscular route in infants aged 6- 12 months - INCENTIVE: QIV-3

Seth GS Medical College and KEM Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Healthy children or children with well controlled pre-existing medical conditions (as concluded from the medical history, physical examination and clinical judgement) age range 6 months â?? 12 months the day of the study
•2. Written, informed consent from parents/guardians.
•3. Parents/Guardians able to understand and comply with the study protocol requirements, including availability for all scheduled visits of the study.

•1. Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-revaluated for eligibility).
•2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5Â°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-evaluated for eligibility.
•3. Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis or medical records (if available) at screening visit.
•4. Administration of any vaccine within 28 days prior to enrolment in the study (except for influenza vaccine which should be >6 months prior to enrollment in the study) or planned administration of any vaccine during study participation
•5. Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study
•6. 16.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the participant could complete the protocol

发起方

Seth GS Medical College and KEM Hospital