Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B & Immune Response to a Hepatitis B Challenge Dose in Healthy Children 4 to 6 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

ClinicalTrials.gov ID

NCT00335881

Acronym / sponsor ID

106745

Conditions

Hepatitis B

Keywords

Prophylaxis for hepatitis B disease

Phase

Phase 4

Study type

Interventional

Recruitment status

Completed

Enrolment

300 participants

Lead sponsor

GlaxoSmithKlineIndustry (pharma, biotech, devices)

Study start

Jun 2006

Study completion

Nov 2006 (actual)

First posted

12 Jun 2006 (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.

Study design

Primary purpose

Prevention

Allocation

Non-randomised

Intervention model

Parallel groups

Masking

None (open label)

Who may qualify

Ages

4 to 6 years

Sex

All

Healthy volunteers

Accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Anti-HBs antibody concentration

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 7 Oct 2016.
• Derived from this study: PubMed 20009522Zinke M, Disselhoff J; DTP a-HBV-IPV-110 and -111 study groups; Gartner B, Jacquet JM. Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin. 2010 Feb;6(2):189-93. doi: 10.4161/hv.6.2.10117.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
• Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Hepatitis B

• Active, not recruitingPhase 2

  A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

  Chronic Hepatitis B Virus Infection, Hepatitis B

• RecruitingObservational study

  Evaluation of Patients With Liver Disease

  Hepatitis D, Hepatitis C

• Active, not recruitingPhase 2

  Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)

  Hepatitis B

• Active, not recruitingPhase 2

  Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

  Hepatitis B

• Enrolling by invitationPhase 1

  A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.

  Chronic Hepatitis B

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.

38 sites in 1 country: see every site and its status.