GastroenteritisRotaNeoNCT02252029
Rotavirus Vaccine in Premature Babies
An observational study of Gastroenteritis, run by University of Oxford at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 weeks
- Conditions the study is for
- Gastroenteritis
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature babies receiving their first dose of rotavirus vaccine while an inpatient on the neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust
Who may be able to join
- 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)
Who cannot join
- Parent is listed on the study delegation log.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Paediatrics, University of Oxford
Oxford, Oxfordshire, OX3 9DU
Oxford University Hospitals NHS Trust
Oxford
About this study
Official title: RotaNeo: Evaluation of Rotavirus Vaccine Administration in Premature Babies in the Neonatal Unit
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.
Read the 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
- Keywords
- Rotavirus, Vaccine
- Medical subject headings
- Gastroenteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days rotavirus vaccine can be detected in stool following immunisation
Measured: 24 months
Secondary outcomes (3)
Measurement of serum and stool antibody to rotavirus vaccine following vaccination
Measured: 24 months
Number of adverse events following rotavirus vaccine
Measured: 12 months
Comparison of vaccine responses after categorisation based on GI microbiome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Pollard, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252029
- Sponsor's protocol ID
- OVG 2014/04
- Acronym
- RotaNeo
- Status last verified
- May 2017
- First submitted
- 25 Sep 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RotaNeo: Evaluation of Rotavirus Vaccine Administration in Premature Babies in the Neonatal Unit
- ClinicalTrials.gov ID
- NCT02252029
- Acronym / sponsor ID
- RotaNeo / OVG 2014/04
- Conditions
- Gastroenteritis
- Keywords
- Rotavirus, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 15 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature babies receiving their first dose of rotavirus vaccine while an inpatient on the neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Parent is listed on the study delegation log.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of days rotavirus vaccine can be detected in stool following immunisation
Time frame: 24 months
3 secondary outcomes
Measurement of serum and stool antibody to rotavirus vaccine following vaccination
Time frame: 24 months
Number of adverse events following rotavirus vaccine
Time frame: 12 months
Comparison of vaccine responses after categorisation based on GI microbiome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Pollard principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days rotavirus vaccine can be detected in stool following immunisation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.