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
Verified date | October 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia, Belgium, Spain,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |