Last updated: 11/07/2018 03:13:22
Study to show that the combined hepatitis A and B vaccine is non-inferior to monovalent vaccines in adults
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects
Timeframe: 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
Timeframe: Two weeks and one month after the challenge dose
Occurrence and intensity of solicited local symptoms
Timeframe: In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship of solicited general symptoms
Timeframe: In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported
Timeframe: During the 31-day follow-up period after the challenge dose
Occurrence of all serious adverse events (SAEs) reported
Timeframe: Following the administration of the challenge dose
Interventions:
Enrollment:
213
Primary completion date:
2008-03-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Chlibek R et al. (2011) Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 18(2):145-148.
Medical condition
Hepatitis B
Product
SB208127
Collaborators
Not applicable
Study date(s)
January 2008 to June 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
41+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
Status
Study Complete
Location
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Showing 1 - 6 of 8 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2008-03-06
Actual study completion date
2008-03-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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