NCT00411697 is a Phase 4 clinical trial of Engerix™-B Kinder in Hepatitis B, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00411697?

NCT00411697 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00411697?

Interventions in NCT00411697: Engerix™-B Kinder.

What condition does NCT00411697 study?

NCT00411697 studies Hepatitis B.

Is NCT00411697 still recruiting?

NCT00411697 is currently completed. Last updated 27 October 2016.

Last reviewed 2016-10-27 · How we verify

NCT00411697

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Assess Long-term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Aged 4-5 Years (Previously Primed & Boosted in the 1st 2 Years of Life With DTPa-HBV-IPV/Hib Vaccine)

Completed Phase 4 Last updated 27 October 2016

What this trial tests

Phase 4 trial testing Engerix™-B Kinder in Hepatitis B in 301 participants. Completed in 1 May 2007.

Timeline

1 December 2006

Primary endpoint
1 May 2007

1 May 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	301
Start date	1 December 2006
Primary completion	1 May 2007
Estimated completion	1 May 2007
Sites	36 locations across Germany

Drugs / interventions tested

Engerix™-B Kinder

Conditions studied

Hepatitis B — all drugs for Hepatitis B →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 4 to 5, any sex, with Hepatitis B. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time frame: One month after the challenge dose of HBV vaccine

Sponsor's own description

The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life.
Steiner M, Ramakrishnan G, Gartner B, Van Der Meeren O, et al · · 2010 · cited 28× · PMID 20078876 · DOI 10.1186/1471-2334-10-9

Verify or expand the search:

Other trials of Engerix™-B Kinder

Trials testing the same drug.

NCT02052661 — This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenic · Phase 4 · completed
NCT01847430 — Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B · Phase 4 · completed
NCT00984139 — Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination · Phase 4 · completed
NCT00519649 — Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination. · Phase 4 · completed

Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00411697 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 27 October 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00411697.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing