Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
This study has been completed.
Information provided by (Responsible Party):
First received: April 4, 2007
Last updated: April 28, 2016
Last verified: February 2016
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||To Evaluate Immune Response to a Hepatitis B Vaccine (Engerix™-B ) Challenge Dose in Healthy Subjects Who Received GSK Biologicals' Hepatitis B Vaccine (Engerix™-B ) Approximately 20 Years Ago as Primary Vaccination at 0, 1, 2 and 12 Months.
Primary Outcome Measures:
Secondary Outcome Measures:
- Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine. ] [ 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.
An AE is considered severe if it prevents normal, everyday activities.
- Number of Participants Reporting Any Serious Adverse Events (SAEs). [ Time Frame: Up to 1 month after the challenge dose. ] [ 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2008 (Final data collection date for primary outcome measure)
Experimental: Group Engerix™-B
Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Intramuscular injection, 1 dose
Other Name: Hepatitis B vaccine
|Ages Eligible for Study:
||20 Years to 21 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine in primary study approximately 20 years earlier.
- Documented level of anti-HBs antibody concentrations < specified concentration at the previous long-term time point for which serological results are available for that subject.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis B challenge dose.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
- Administration of a vaccine not foreseen by the study protocol during the study period.
- Administration of immunoglobulins and/or any blood products during the study period.
- Drug and/or alcohol abuse.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456625
|GSK Investigational Site
|Bangkok, Thailand, 10330 |
||GSK Clinical Trials
Poovorawan Y et al. 20-year follow-up of immunogenicity and efficacy of infant hepatitis B vaccination. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
Poovorawan Y et al. 20-year persistence of immune response to infant hepatitis B vaccination in a high endemicity region. Abstract presented at the 13th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Washington DC, US, 20-24 March 2009.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 4, 2007
|Results First Received:
||January 15, 2009
||April 28, 2016
||Thailand: not applicable
Keywords provided by GlaxoSmithKline:
Hepatitis B vaccine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections
Physiological Effects of Drugs