Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

Hepatitis B Clinical Trial

Official title:

Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343915
• Other study ID #: 101695 Ext. Mth30
• Secondary ID: 1016961016971016
• Status: Completed
• Phase: Phase 3
• Start date: April 21, 2004
• Est. completion date: January 10, 2008

Study information

• Verified date: February 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.

Subjects were aged 11 to 15 years at the time of the primary vaccination course.

At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.

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

Description:

All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Other known NCT identifiers

• NCT00787228

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: January 10, 2008
• Est. primary completion date: January 10, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

Inclusion Criteria:

• Subjects have participated in primary study HBV-280

• Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™-B (thiomersal-free) 20µg
In the primary study: 2 deep intramuscular injections (Months 0, & 6)
• 10 µg Engerix™-B (preservative-free)
In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)
• placebo
In the primary study: 1 deep intramuscular injection (month 1)

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Sydney	New South Wales
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Wilrijk
Ukraine	GSK Investigational Site	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Belgium,  Ukraine, 

References & Publications (3)

Heron L, Selnikova O, Moiseieva A, Van Damme P, van der Wielen M, Levie K, Hoet B, Stoffel M. Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial. Vaccine. 2007 Apr 12;25(15):2817-22. Epub 2006 Dec 29. — View Citation

Heron LG, Chant KG, Jalaludin BB. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine. 2002 Oct 4;20(29-30):3472-6. — View Citation

Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.	At Month 7
Primary	Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.	At Month 30, Month 42, Month 54 and Month 66
Primary	Antibody Titers Against Hepatitis-B Virus.	Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.	At Month 30, Month 42, Month 54 and Month 66
Secondary	Antibody Titers Against Hepatitis-B Virus.	Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.	At Months 1, 2, 6 and 7
Secondary	Number of Subjects Seroprotected for Anti-HBs Antibody.	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.	At Months 1, 2 and 6
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.	During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.	Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.	During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Secondary	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).	An unsolicited AE covers 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 31-day (Day 0-30) follow-up period after each vaccination and overall
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.	During the entire study period (Month 0 to Month 66)
Secondary	Number of Subjects With Serious Adverse Events (SAEs).	erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.	At Month 30, Month 42, Month 54 & Month 66

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