Assessment of viral shedding week following administration of live attenuated influenza vaccine in children: FluSHED-2 study - FluSHED-2

Imperial College London JRC Office0 个研究点目标入组 30 人开始时间: 2018年7月10日最近更新: 2020年7月27日

试验速览

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•1.Children age 6 years to 15 years +364 days of age on enrolment
•2.Children eligible to receive LAIV in accordance with Green Book advice [https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book]
•3.Written informed consent given by parent/ guardian and assent from child (both must be in place to proceed).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1.Contraindications to LAIV (notwithstanding allergy to egg protein), which include:
•a.Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
•b.Previous systemic allergic reaction to LAIV
•c.Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the CI to confirm patient suitability
•d.Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids*.
•*High-dose steroids is defined as a treatment course for at least one month, equivalent to a dose greater than 20mg prednisolone per day (any age), or for children under 20kg, a dose greater than 1mg/kg/day.
•NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled/low-dose oral systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
•e.Children / adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
•f.Pregnancy (determined by history). Where this cannot be confirmed, a urine pregnancy test will be performed.

发起方

Imperial College London JRC Office