Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

Hepatitis B Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411697
• Other study ID #: 106789
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2006
• Last updated: October 27, 2016
• Start date: December 2006
• Est. completion date: May 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 5 Years

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

• A male or female of 4 to 5 years of age at the time of enrolment.

• With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ in Germany.

• Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• 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 booster vaccination and ending 30 days after.

• Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™-B Kinder
Intramuscular injection, 1 dose

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Bad Saulgau	Baden-Wuerttemberg
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bietigheim/Bissingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Boennigheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Cham	Bayern
Germany	GSK Investigational Site	Dudenhofen	Rheinland-Pfalz
Germany	GSK Investigational Site	Ehingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Gau-Odernheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Gerolstein	Rheinland-Pfalz
Germany	GSK Investigational Site	Herbolzheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kirchzarten	Baden-Wuerttemberg
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Oberstenfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Offenburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Pforzheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Schoeneberg - Kuebelberg	Rheinland-Pfalz
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tegernsee	Bayern
Germany	GSK Investigational Site	Tettnang	Baden-Wuerttemberg
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Tuttlingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Steiner M, Ramakrishnan G, Gartner B, Van Der Meeren O, Jacquet JM, Schuster V. 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. BMC Infect Dis. 2010 Jan 15;10:9. doi: 10.1186/1471-2334-10-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-hepatitis B surface antigen (HBs) antibody concentrations		One month after the challenge dose of HBV vaccine	No
Secondary	Anti-HBs antibody concentrations		Before and after challenge dose of HBV vaccine	No
Secondary	Occurrence of serious adverse events		During the entire study period.	Yes

External Links

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