Clinical trial NCT00343915: Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Persistence
Hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-23
Enrollment: 267
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
timeFrame: At Month 7
measure: Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
timeFrame: At Month 30, Month 42, Month 54 and Month 66
measure: Antibody Titers Against Hepatitis-B Virus.
timeFrame: At Month 30, Month 42, Month 54 and Month 66
Secondary outcomes:
measure: Antibody Titers Against Hepatitis-B Virus.
timeFrame: At Months 1, 2, 6 and 7
measure: Number of Subjects Seroprotected for Anti-HBs Antibody.
timeFrame: At Months 1, 2 and 6
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).
timeFrame: During the 31-day (Day 0-30) follow-up period after each vaccination and overall
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Month 0 to Month 66)
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: At Month 30, Month 42, Month 54 & Month 66
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.vaccine.2006.12.021. Epub 2006 Dec 29.
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. doi: 10.1016/s0264-410x(02)00346-8.
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.