NCT02252029

Rotavirus Vaccine in Premature Babies

RotaNeo: Evaluation of Rotavirus Vaccine Administration in Premature Babies in the Neonatal Unit

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 8 Weeks – 15 Weeks
• Healthy volunteers: Not accepted

Summary

This study will establish the duration of excretion of rotavirus vaccine in stool following vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.

Detailed description

Rotavirus is the commonest cause of severe gastroenteritis in young children, and premature babies are at high risk of serious disease. The RV1 rotavirus vaccine is an altered form of the virus and is given to all children at 8 weeks and 12 weeks of age in the UK. It is given by mouth and excreted in the stool following vaccination - the vaccine virus can therefore be transmitted between people in the same way as the normal virus. Premature babies often receive their initial vaccines while they are still hospitalised in neonatal units. There are no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is a theoretical risk of transmission of the vaccine virus to other babies in the unit (if there was inadequate staff hand washing). Some countries have therefore advised against immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies. This is an observational study of babies admitted to the neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust who receive their first dose of rotavirus vaccine during their hospital stay.

Conditions

• Gastroenteritis

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2014-09-29
• Last updated: 2017-05-09

Locations

2 sites across 1 country: United Kingdom