Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289731
First received: February 9, 2006
Last updated: October 27, 2011
Last verified: October 2011
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Purpose
The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Hepatitis A |
Biological: TWINRIX™ Biological: Engerix™-B Biological: HAVRIX™ Biological: HB VAX PRO™ Biological: Vaqta™ |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines |
Resource links provided by NLM:
Drug Information available for:
Recombinant Hepatitis B vaccine
Hepatitis A and Hepatitis B Vaccine
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Anti- HAV and anti-HBs- concentrations [ Time Frame: 1 month after the last vaccine dose (at Month 7) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Anti-HAV, and anti-HBs antibody concentrations. [ Time Frame: At Months 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs). [ Time Frame: Up to Month 7 ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of SAEs with causal relationship to vaccination or referring to hepatitis A or B infection. [ Time Frame: After Month 7 and up to the study end. ] [ Designated as safety issue: No ]
| Enrollment: | 577 |
| Study Start Date: | November 2003 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
GSK Biologicals' combined Hepatitis A and B vaccine was administered.
|
Biological: TWINRIX™
Intramuscular injection, 3 doses
|
|
Active Comparator: Group B
GSK Biologicals' monovalent hepatitis A and hepatitis B vaccines were administered separately.
|
Biological: Engerix™-B
Intramuscular injection, 3 doses
Biological: HAVRIX™
Intramuscular injection, 2 doses
|
|
Active Comparator: Group C
Aventis Pasteur's monovalent hepatitis A and hepatitis B vaccines were administered separately.
|
Biological: HB VAX PRO™
Intramuscular injection, 3 doses
Biological: Vaqta™
Intramuscular injection, 2 doses
|
Detailed Description:
The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.
Eligibility| Ages Eligible for Study: | 41 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
- Written informed consent obtained from the subject.
- No serological signs of hepatitis A or B infection at screening.
- 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 (drug or vaccine) 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 100382.
- 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.
- Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289731
Locations
| Belgium | |
| GSK Investigational Site | |
| Wilrijk, Belgium, 2610 | |
| Czech Republic | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 01 | |
| Germany | |
| GSK Investigational Site | |
| Finsterwalde, Brandenburg, Germany, 03238 | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01129 | |
| GSK Investigational Site | |
| Geringswalde, Sachsen, Germany, 09326 | |
| GSK Investigational Site | |
| Pirna, Sachsen, Germany, 01796 | |
| GSK Investigational Site | |
| Bad Bramstedt, Schleswig-Holstein, Germany, 24576 | |
| GSK Investigational Site | |
| Bad Segeberg, Schleswig-Holstein, Germany, 23795 | |
| GSK Investigational Site | |
| Elmshorn, Schleswig-Holstein, Germany, 25335 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00289731 History of Changes |
| Other Study ID Numbers: | 100382, 100383, 100384, 100385 |
| Study First Received: | February 9, 2006 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by GlaxoSmithKline:
|
Combined hepatitis A and hepatitis B vaccine Hepatitis B Hepatitis A Monovalent hepatitis A and hepatitis B vaccines |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Viral, Human Liver Diseases Digestive System Diseases |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 22, 2013