Rotavirus Vaccine in Premature Babies

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02252029

Acronym

RotaNeo

Enrollment

Registered

2014-09-29

Start date

2014-12-31

Completion date

2016-09-30

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis

Keywords

Rotavirus, Vaccine

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Weeks to 15 Weeks

Healthy volunteers

Inclusion criteria

* Participant's parent is willing and able to give informed consent for participation in the study. * Current inpatient in the neonatal unit and expected to remain an inpatient for at least 14 days following immunisation with rotavirus vaccine. * Due to receive rotavirus vaccination during their admission. * Born at less than 37 completed weeks gestation (i.e. up to and including 36 weeks and 6 days)

Exclusion criteria

• Parent is listed on the study delegation log.

Design outcomes

Primary

Measure	Time frame
Number of days rotavirus vaccine can be detected in stool following immunisation	24 months

Secondary

Measure	Time frame
Measurement of serum and stool antibody to rotavirus vaccine following vaccination	24 months
Number of adverse events following rotavirus vaccine	12 months
Comparison of vaccine responses after categorisation based on GI microbiome	—

Countries

United Kingdom

Outcome results