NCT Number: NCT00603252
Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults
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).
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Conditions
Age range
41 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
GSK Investigational Site, Wilrijk, Belgium
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Engerix-B
BiologicalHavrix
BiologicalHBVAXPRO
BiologicalVaqta
BiologicalPrimary outcomes
-
Anti-HAV immune response to the challenge dose
-
Anti-HBs antibody response to the challenge dose
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study 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
Important dates
- Study start
- 2008
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Jan 29, 2008
- Registry last updated
- Mar 14, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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