Hepatitis B Clinical Trial
Official title:
Administration of a Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine.
Verified date | November 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when
given to subjects who had received primary vaccination of Engerix™-B vaccine approximately
72-78 months ago.
This protocol posting deals with objectives & outcome measures of the challenge phase. The
Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Status | Completed |
Enrollment | 144 |
Est. completion date | May 14, 2008 |
Est. primary completion date | May 14, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 22 Years |
Eligibility |
Inclusion Criteria: - Subjects who the investigator believes that they can and will comply with the requirements of the protocol. - A male or female who had received complete primary vaccination course of hepatitis B vaccine in the primary study - Written informed consent obtained from the subject and/or parent/guardian of 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 the hepatitis B challenge dose. Exclusion Criteria: - Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period. - Chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose. - Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after. - Subjects who received an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination visit. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Acute disease at the time of enrolment. - Acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. - Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period (one month). - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions. |
Country | Name | City | State |
---|---|---|---|
Australia | GSK Investigational Site | Westmead | New South Wales |
Belgium | GSK Investigational Site | Bruxelles | |
Belgium | GSK Investigational Site | Wilrijk |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia, Belgium,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Immune response defined as: For initially seronegative subjects (anti-HBs antibody concentration <3.3 milli-international unit per milliliter [mIU/mL] before vaccination) antibody concentration = 10mIU/mL at post booster. For initially seropositive subjects: antibody concentration at post booster = 4-fold the pre-vaccination antibody concentration. |
30 days post-challenge dose | |
Secondary | Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL. | 30 days post-challenge dose | |
Secondary | Concentration of Anti-HBs Antibodies | Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL. | 30 days post-challenge dose | |
Secondary | Number of Participants Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | During the 4-day follow-up period (Day 0-3) after the challenge dose | |
Secondary | Number of Participants Reporting Solicited General Symptoms | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache. | During the 4-day follow-up period (Day 0-3) after the challenge dose | |
Secondary | Number of Participants Reporting Unsolicited Adverse Events (AE) | 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. | During the 31-day follow-up period (Day 0-30) after the challenge dose | |
Secondary | Number of Participants Reporting Serious Adverse Events (SAE) | 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. | During the 31-day follow-up period (Day 0-30) after the challenge dose |
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