Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
Long-term Antibody Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Previously Vaccinated With Infanrix Hexa Vaccine
1 other identifier
interventional
300
1 country
12
Brief Summary
This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2011
Shorter than P25 for phase_4
12 active sites
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
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 12, 2011
CompletedStudy Start
First participant enrolled
April 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2011
CompletedResults Posted
Study results publicly available
August 22, 2012
CompletedJune 6, 2018
August 1, 2016
5 months
April 7, 2011
July 19, 2012
April 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Secondary Outcomes (9)
Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.
Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine
Before (Day 0) a challenge dose of Engerix-B Kinder vaccine
Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values
One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Anti-HBs Antibody Concentrations
One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine
Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose
After Engerix-B Kinder challenge dose (Month 1)
- +4 more secondary outcomes
Study Arms (1)
Engerix-B Kinder Group
EXPERIMENTALSubjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female 7 to 8 years of age at the time of enrolment.
- Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
- Written informed consent obtained from the parents/Legally Acceptable Representative(s) of the subject at the time of enrolment.
- In addition to the informed consent that will be signed by the parent(s)/Legally Acceptable Representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
You may not qualify if:
- Child in care
- Use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
- History of or intercurrent hepatitis B disease.
- Hepatitis B vaccination at birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the hepatitis B vaccine challenge dose.
- Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis B vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute disease and/or fever at the time of enrolment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435, Germany
GSK Investigational Site
Braunatal, Hesse, 34225, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48163, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547, Germany
GSK Investigational Site
Berlin, 13055, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 12, 2011
Study Start
April 26, 2011
Primary Completion
September 28, 2011
Study Completion
September 28, 2011
Last Updated
June 6, 2018
Results First Posted
August 22, 2012
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.