Hepatitis B Clinical Trial
Official title:
Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults
Verified date | March 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
Status | Completed |
Enrollment | 213 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 41 Years and older |
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 completed the primary vaccination phase of the study. - Written informed consent obtained from the subject. - If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Exclusion Criteria: - Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. - History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Acute disease at the time of enrolment. - Pregnant or lactating female. |
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Investigational Site | Wilrijk | |
Germany | GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein |
Germany | GSK Investigational Site | Bad Segeberg | Schleswig-Holstein |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Elmshorn | Schleswig-Holstein |
Germany | GSK Investigational Site | Finsterwalde | Brandenburg |
Germany | GSK Investigational Site | Geringswalde | Sachsen |
Germany | GSK Investigational Site | Pirna | Sachsen |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-HAV immune response to the challenge dose | |||
Primary | Anti-HBs antibody response to the challenge dose | |||
Secondary | Percentage of subjects with anti-HAV antibody titres = 15 mIU/ml and GMTs calculated on seropositive subjects | Two weeks and one month after the challenge dose | ||
Secondary | Percentage of subjects with anti-HBs antibody titres = 3.3 mIU/ml, = 10 mIU/ml, = 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects | Two weeks and one month after the challenge dose | ||
Secondary | Occurrence and intensity of solicited local symptoms | In the 4-day follow-up period after the challenge dose | ||
Secondary | Occurrence, intensity and relationship of solicited general symptoms | In the 4-day follow-up period after the challenge dose | ||
Secondary | Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported | During the 31-day follow-up period after the challenge dose | ||
Secondary | Occurrence of all serious adverse events (SAEs) reported | Following the administration of the challenge dose |
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