Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults
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All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects [ Time Frame: Two weeks and one month after the challenge dose ]
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 [ Time Frame: Two weeks and one month after the challenge dose ]
Occurrence and intensity of solicited local symptoms [ Time Frame: In the 4-day follow-up period after the challenge dose ]
Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: In the 4-day follow-up period after the challenge dose ]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported [ Time Frame: During the 31-day follow-up period after the challenge dose ]
Occurrence of all serious adverse events (SAEs) reported [ Time Frame: Following the administration of the challenge dose ]
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Ages Eligible for Study:
41 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.