NCT02252029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

September 25, 2014

Last Update Submit

May 8, 2017

Conditions

Gastroenteritis

Keywords

RotavirusVaccine

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (3)

  • 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

Eligibility Criteria

Age8 Weeks - 15 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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)

You may not qualify if:

  • Parent is listed on the study delegation log.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Paediatrics, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool, serum

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Andrew Pollard

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 29, 2014

Study Start

December 1, 2014

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

GB(2)