Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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
Primary Completion Date
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 ]
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, Learn About Clinical Studies.
Ages Eligible for Study:
41 Years and older (Adult, Senior)
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.