NCT00873652

Brief Summary

The UK immunisation guidelines recommend that children immunised with an accelerated course of hepatitis B vaccine (i.e. vaccination at 0, 1, 2 and 12 months) receive an additional booster dose of vaccine in later childhood (usually at 3 1/2 years of age). The primary objective of this study is to to assess what proportion of these children have 'protective' concentrations (10mIU/ml) of hepatitis B specific antibodies before and after the booster dose of hepatitis B vaccine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

January 27, 2009

Last Update Submit

December 7, 2017

Conditions

Healthy

Keywords

Hepatitis B vaccineBooster dosePersistenceImmune responseHealthy children

Outcome Measures

Primary Outcomes (1)

  • The percentage of participants completing an accelerated course of hepatitis B vaccination with 10 IU/ml Hepatitis B surface antigen specific antibodies (antiHBs) before and after the 'pre-school' booster dose of Hepatitis B vaccine.

    immediately prior to vaccination and 4 weeks post vaccination

Secondary Outcomes (3)

  • To evaluate the percentage of participants who had serum antiHBs concentrations < 10 IU/ml at visit 1 who had a rise in serum antiHBs to 10 IU/ml at visit 2.

    immediately prior to vaccination and 4 weeks post-vaccination

  • To evaluate the percentage of participants who had serum antiHBs concentrations < 10 IU/ml at visit 1 who had a rise in serum antiHBs to 100 IU/ml at visit 2.

    immediately prior to vaccination and 4 weeks post-vaccination

  • To evaluate the serum antiHBs geometric mean concentrations (GMCs) at visit 1 and visit 2.

    immediately prior to vaccination and 4 weeks post-vaccination

Interventions

Engerix B®, a recombinant hepatitis B vaccineBIOLOGICAL

Single 0.5 ml dose intramuscularly into the deltoid muscle

Also known as: Hepatitis B Vaccine (Recombinant)

Eligibility Criteria

Age41 Months - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children have been recorded as having commenced an accelerated course of HBV vaccine between the years 2000 and 2006

You may qualify if:

  • Parent/guardian is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 3 years 4 months or above.
  • Commenced Hepatitis B post exposure prophylaxis at birth.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

  • Parent/guardian is not willing or able to give informed consent for participation in the study.
  • The child is currently enrolled in any other interventional research study
  • History of a confirmed anaphylactic reaction to a previous dose of hepatitis B containing vaccine or a confirmed reaction to any component of the vaccine
  • Evidence of infection with HBV on previous blood tests.
  • Previous receipt of booster doses of HBV vaccine within the 2 years prior to study enrolment.
  • Significant renal or hepatic impairment.
  • Participant who is terminally ill.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/participant at risk because of participation in the study, or may influence the result of the study, or the patient/participant's ability to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • Yates TA, Paranthaman K, Yu LM, Davis E, Lang S, Hackett SJ, Welch SB, Pollard AJ, Snape MD. UK vaccination schedule: persistence of immunity to hepatitis B in children vaccinated after perinatal exposure. Arch Dis Child. 2013 Jun;98(6):429-33. doi: 10.1136/archdischild-2012-302153. Epub 2013 Mar 9.

    PMID: 23476003BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Hepatitis B

Interventions

Engerix-BHepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Matthew D Snape, MBBS, FRCPCH

    Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2009

First Posted

April 1, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 8, 2017

Record last verified: 2017-12

Locations

GB(1)