|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00289744 |
|
Date of registration:
|
09/02/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
|
|
Scientific title:
|
Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children |
|
Date of first enrolment:
|
February 2004 |
|
Target sample size:
|
171 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00289744 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
GSK Clinical Trials |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
GlaxoSmithKline |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Subjects participating in this study should have participated in the primary study
with combined hepatitis A/ hepatitis B vaccine.
- 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.
Age minimum:
7 Years
Age maximum:
17 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hepatitis A
|
|
Hepatitis B
|
|
Intervention(s)
|
|
Biological: Engerix TM
|
|
Biological: TWINRIX™ ADULT
|
|
Primary Outcome(s)
|
|
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
[Time Frame: Years 6, 7, 8, 9, and 10.]
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
[Time Frame: At Year 6, 7, 8, 9 and 10]
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
[Time Frame: Before and 1 month after the additional dose administration]
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
[Time Frame: During the 30-day follow-up period after additional dose]
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
[Time Frame: At Year 6, 7, 8, 9 and 10]
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
[Time Frame: During the 4-day follow-up period after additional dose]
|
|
Number of Subjects Reporting Unsolicited Adverse Events
[Time Frame: During the 30-day follow-up period after additional dose]
|
|
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
[Time Frame: One month after the additional dose administration]
|
|
Secondary ID(s)
|
|
100561 (Y6)
|
|
100562 (Year 7)
|
|
100563 (Year 8)
|
|
100564 (Year 9)
|
|
100565 (Year 10)
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|