Hepatitis APhase 3NCT00197249
Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity
A Phase 3 study testing Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix in people with Hepatitis A, run by GlaxoSmithKline.
Trial summary
To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix, and when compared to the administration of monovalent vaccines, Havrix or Typhim Vi. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix
- Type of treatment
- Vaccines
- How many people
- 1,034 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent will be obtained from the subject prior to entry into the study.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Seronegative for anti-HAV antibodies.
- If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) 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.
- Subjects having received the study vaccines 36 months earlier.
Who cannot join
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >or = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
- Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- History of chronic alcohol consumption and/or intravenous drug abuse.
- Previous vaccination against hepatitis A.
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- Previous vaccination against typhoid fever.
- History of hepatitis A.
- Previous diagnosis, confirmed by a physician, of Salmonella typhi infection.
- History of non-response to hepatitis A and or typhoid vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature < 99.5 °F (37.5 °C)
- Female planning to become pregnant during the primary study period (up Month 7).
- Pregnant or lactating female.
- Planned travel to areas of high endemicity for hepatitis A and/ or typhoid fever during the primary study period (up Month 7).
About this study
Official title: A Phase III, Open, Randomized, Multicentric Study to Compare the Reactogenicity and Immunogenicity of GSK Biologicals' Combined Vi Polysaccharide Typhoid Vaccine and Inactivated Hepatitis A Vaccine, to That Elicited by GSK Biologicals' Hepatitis A Vaccine, Administered Singly or Concomitantly With GSK Biologicals' Vi Polysaccharide Vaccine
To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix, and when compared to the administration of monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the first dose of the study vaccine.
Read the detailed description
Compare the reactogenicity \& immunogenicity of GSK Biologicals' combined Vi polysaccharide typhoid vaccine \& inactivated hepatitis A vaccine, Hepatyrix, to that elicited by GSK Biologicals' hepatitis A vaccine, Havrix administered singly or concomitantly with GSK Biologicals' Vi polysaccharide vaccine, Typherix, \& to that elicited by Aventis Pasteur's monovalent Vi polysaccharide vaccine, Typhim Vi, administered intramuscularly to healthy subjects aged 18-65 yrs.
- Conditions
- Hepatitis A
- Being tested
- Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix
- Keywords
- Hepatitis A & B, Typhoid
- Medical subject headings
- Hepatitis A, Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- HepatyrixBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Vi seropositivity rates (i.e., percentage of subjects with anti-Vi antibody titres > or = 150 EL.U/ml) at Month 1 after administration of study vaccine (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Typhim Vi).
Anti-HAV seropositivity rates (i.e., percentage of subjects with anti-HAV antibody titres >or = 15 mIU/ml) at Month 1 after administration of study vaccine, (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Havrix).
Secondary outcomes (7)
Anti-Vi seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
Anti-HAV seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
Anti-Vi and anti-HAV seropositivity rates and GMTs at Months 12, 24, 36 after administration of study vaccine.
Occurrence and intensity of solicited local symptoms after vaccination (Day 0 to 4).
Occurrence, intensity and relationship of solicited general symptoms after vaccination (Day 0 to 4).
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms after vaccination (Day 0 to 30).
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) during the study period and during the follow-up period up to Months 12, 24 and 36 after administration of study vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionJun 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197249
- Sponsor's protocol ID
- 270362/006
- Other IDs
- 270362/007 (Ext. Mth12), 270362/008 (Ext. Mth24), 270362/009 (Ext. Mth36)
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2005
- Last updated
- 9 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open, Randomized, Multicentric Study to Compare the Reactogenicity and Immunogenicity of GSK Biologicals' Combined Vi Polysaccharide Typhoid Vaccine and Inactivated Hepatitis A Vaccine, to That Elicited by GSK Biologicals' Hepatitis A Vaccine, Administered Singly or Concomitantly With GSK Biologicals' Vi Polysaccharide Vaccine
- ClinicalTrials.gov ID
- NCT00197249
- Acronym / sponsor ID
- 270362/006
- Conditions
- Hepatitis A
- Keywords
- Hepatitis A & B, Typhoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix, and when compared to the administration of monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the first dose of the study vaccine.
Detailed description
Compare the reactogenicity \& immunogenicity of GSK Biologicals' combined Vi polysaccharide typhoid vaccine \& inactivated hepatitis A vaccine, Hepatyrix, to that elicited by GSK Biologicals' hepatitis A vaccine, Havrix administered singly or concomitantly with GSK Biologicals' Vi polysaccharide vaccine, Typherix, \& to that elicited by Aventis Pasteur's monovalent Vi polysaccharide vaccine, Typhim Vi, administered intramuscularly to healthy subjects aged 18-65 yrs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent will be obtained from the subject prior to entry into the study.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Seronegative for anti-HAV antibodies.
- If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) 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.
- Subjects having received the study vaccines 36 months earlier.
Key exclusion criteria (17 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >or = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
- Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- History of chronic alcohol consumption and/or intravenous drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix | Biological | – |
Primary outcome
Anti-Vi seropositivity rates (i.e., percentage of subjects with anti-Vi antibody titres > or = 150 EL.U/ml) at Month 1 after administration of study vaccine (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Typhim Vi).
Anti-HAV seropositivity rates (i.e., percentage of subjects with anti-HAV antibody titres >or = 15 mIU/ml) at Month 1 after administration of study vaccine, (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Havrix).
7 secondary outcomes
Anti-Vi seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
Anti-HAV seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
Anti-Vi and anti-HAV seropositivity rates and GMTs at Months 12, 24, 36 after administration of study vaccine.
Occurrence and intensity of solicited local symptoms after vaccination (Day 0 to 4).
Occurrence, intensity and relationship of solicited general symptoms after vaccination (Day 0 to 4).
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms after vaccination (Day 0 to 30).
Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) during the study period and during the follow-up period up to Months 12, 24 and 36 after administration of study vaccine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix in people with Hepatitis A, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Vi seropositivity rates (i.e., percentage of subjects with anti-Vi antibody titres > or = 150 EL.U/ml) at Month 1 after administration of study vaccine (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Typhim Vi).. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.