NOPRODRSV0015 Global RSV (Birth) Cohort Study - Amendment 1

• Research type

  Research Study

• Full title

  Global Prospective (Birth) Cohort Study to Investigate Early Signs and Symptoms and Early Viral Kinetics of Respiratory Syncytial Virus (RSV) Disease in Children During the RSV Circulation Using Digital Health Technology (Mobile App)

• IRAS ID

  287355

• Contact name

  John Tsun Fai Ho

• Contact email

  john.ho3@nhs.net

• Sponsor organisation

  Janssen-Cilag International NV

• Duration of Study in the UK

  0 years, 7 months, 0 days

• Research summary

  Summary of Research
  This prospective cohort study is designed to identify early signs and symptoms of developing Respiratory Syncytial Virus (RSV) disease in children using a smartphone application (RSV mobile App). The study is conducted in 2 consecutive cohorts i.e. groups. The participants in Cohort 1 are healthy infants <4 months of age at enrollment. The participants in Cohort 2 are infants and toddlers born prematurely and up to 18 months of age at enrollment. The RSV mobile App is used as a directive tool where parent(s)/caregiver(s) receive questionnaires twice daily which have to be completed to document the health condition of their child. Based on the answers, the parent(s)/caregiver(s) may get a request via the mobile App to collect nasal mucus samples from their child with a swab. The results from this study will provide unique information for RSV vaccine and antiviral treatment development. At the time of this submission (protocol amendment 1) Cohort 1 is closed and participants in Cohort 2 will be included in the next RSV circulation season 2020-2021.

  Summary of Results
  N/A

• REC name

  London - City & East Research Ethics Committee

• REC reference

  20/PR/0374

• Date of REC Opinion

  15 Sep 2020

• REC opinion

  Favourable Opinion