Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
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Purpose
The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis A |
Biological: Havrix™ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Long Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per ml and Injected According to a 0, 6-month Schedule in Healthy Adult Subjects |
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [ Time Frame: At Years 11, 12, 13, 14, 15, 16, 17, 18 and 19 after the first vaccine dose of the 2-dose primary vaccination ] [ Designated as safety issue: No ]
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).
The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging.
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [ Time Frame: Before the additional dose, 14 days and 30 days after the additional dose ] [ Designated as safety issue: No ]Concentrations given as GMC expressed as mIU/mL.
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [ Time Frame: At Year 20 after the first vaccine dose of the 2-dose primary vaccination ] [ Designated as safety issue: No ]
Concentrations given as GMC expressed as mIU/mL.
Data have been analyzed up to Year 19. Results for additional time points will be disclosed when available.
- Number of Seropositive Subjects for Anti-HAV Antibodies. [ Time Frame: From Year 11 to Year 19 ] [ Designated as safety issue: No ]
Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 19 time points.
The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging.
- Number of Seropositive Subjects for Anti-HAV Antibodies. [ Time Frame: At Year 20 ] [ Designated as safety issue: No ]
- Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy [ Time Frame: Years 11, 12, 13, 14, 15, 16, 17, 18 and 19 after the first vaccine dose of the 2-dose primary vaccination ] [ Designated as safety issue: No ]An 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
- Occurrence of Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy [ Time Frame: Years 20 after the first vaccine dose of the 2-dose primary vaccination ] [ Designated as safety issue: No ]
An 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.
Data have been analyzed up to Year 19. Results for additional time points will be added when available.
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after additional vaccination ] [ Designated as safety issue: No ]
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain = symptom that prevented normal activities. Grade 3 redness and swelling = redness or swelling above 30 mm and persisting more than 24 hours.
Any = incidence of a particular symptom regardless of intensity.
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after additional vaccination ] [ Designated as safety issue: No ]Solicited general symptoms assessed included fatigue, fever, gastrointestinal symptoms, and headache.
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE) [ Time Frame: During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15) ] [ Designated as safety issue: No ]
An AE 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. Grade AE = produced significant impairment of functioning or incapacitation and was a definite hazard to the subject's health.
Related AE = assessed by the investigator as related to the study vaccination.
- Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the follow-up period after additional vaccination up to Year 19 ] [ Designated as safety issue: No ]An 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.
- Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the follow-up period after additional vaccination up to Year 20 ] [ Designated as safety issue: No ]
An 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.
Data have been analyzed up to Year 19. Results for additional time points will be disclosed when available.
| Enrollment: | 78 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Havrix Group
Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up. |
Biological: Havrix™
2 doses at 6 months interval
|
Detailed Description:
This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination, 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to include an extended follow up period up to Year 20 after primary vaccination.
The study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030, 111031, 111032).
Eligibility| Ages Eligible for Study: | 29 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who had received at least one dose of the study vaccine in the primary study
- Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00289757 History of Changes |
| Other Study ID Numbers: | 100576 (Y11), 100577 (Y12), 100578 (Y13), 100579 (Y14), 100580 (Y15), 111028 (Y16), 111029 (Y17), 111030 (Y18), 111031 (Y19), 111032 (Y20) |
| Study First Received: | February 9, 2006 |
| Results First Received: | December 10, 2009 |
| Last Updated: | March 21, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by GlaxoSmithKline:
|
Havrix™ Hepatitis A |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on May 23, 2013