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Completed

NCT Number: NCT02252029

Rotavirus Vaccine in Premature Babies

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.

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Key information

Age range

8 week–15 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Paediatrics, University of Oxford, Oxford, Oxfordshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of days rotavirus vaccine can be detected in stool following immunisation

    Time frame: 24 months

Secondary outcomes

  1. Measurement of serum and stool antibody to rotavirus vaccine following vaccination

    Time frame: 24 months

  2. Number of adverse events following rotavirus vaccine

    Time frame: 12 months

  3. Comparison of vaccine responses after categorisation based on GI microbiome

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Acronym: RotaNeo

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2014
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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