Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

Hepatitis B Clinical Trial

Official title:

Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197184
• Other study ID #: 208127/132 (EXT Y2)
• Secondary ID: 208127/133 (EXT
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2003
• Est. completion date: March 10, 2004

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description:

Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

Other known NCT identifiers

• NCT00787449

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: March 10, 2004
• Est. primary completion date: March 10, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

Inclusion Criteria:

• Participation in primary study

• Written informed consent obtained before each long term follow up visit.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Twinrix™ Adult
Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
• Twinrix™ Junior
Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Carlton	Victoria
Australia	GSK Investigational Site	North Adelaide	South Australia
Belgium	GSK Investigational Site	Bruxelles
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Blanes (Girona)
Spain	GSK Investigational Site	Cerdanyola Del Vallés / Barcelona
Spain	GSK Investigational Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Belgium,  Spain, 

References & Publications (1)

Marshall H, Nolan T, Díez Domingo J, Rombo L, Sokal EM, Marès J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years. Vaccine. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-hepatitis A (HAV) Antibody Concentrations	Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)	Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Primary	Anti-hepatitis B (HBs) Antibody Concentrations	Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).	Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Primary	Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.	Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.	Before and one month after additional vaccination
Primary	Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.	Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).	Before and One month after additional vaccination
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.	A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	From last study visit of the primary study up to Year 5 long term follow-up
Secondary	Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.; Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful	during the 4-day follow-up period after additional vaccination
Secondary	Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.	Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.; Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination	During the 4-day follow-up period after additional vaccination
Secondary	Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	During the 30-day follow-up period after additional vaccination.
Secondary	Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events	A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	At least one month after additional vaccination

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