Hepatitis BPhase 4NCT01457547
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course
A Phase 4 study testing DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) in people with Hepatitis B and Poliomyelitis, run by GlaxoSmithKline at 9 sites in 3 countries.
Trial summary
The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule. Read more about this study
- Who is it for?
- Ages 8 to 15 weeksHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Poliomyelitis, Diphtheria
- What is being tested?
- DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Oct 2003to May 2005
- Phase
- Phase 4
- 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 8 to 15 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a normal gestation period between 36 and 42 weeks.
Who cannot join
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease.
- Planned administration of a vaccine not foreseen by the study protocol since birth and during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose of the three-dose primary vaccination course, with the exception of licensed Neisseria meningitides conjugate vaccines or Bacillus Calmette-Guérin (BCG) vaccine that can be given in between study visits or after the third visit, provided they are given preferably with a 4 weeks interval but not less than 3 weeks apart from the study vaccine doses.
- Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs since birth.
- Planned administration of immunoglobulins and/or any blood products since birth or planned administration during the period up to 30 days after the third dose of the primary vaccination course.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
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- History of seizures, progressive neurological disease or intra-cerebral haemorrhage.
- Major congenital defects or serious chronic illness.
- Acute febrile illness at the time of planned vaccination
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Italy6 sites
GSK Investigational Site
Bari, Apulia, 70124
GSK Investigational Site
Bologna, Emilia-Romagna, 40138
GSK Investigational Site
Galatina (LE), Apulia, 73013
GSK Investigational Site
Maglie (LE), Apulia, 73024
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Sassari, Sardinia, 07100
Sweden2 sites
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Örebro, SE-701 85
About this study
Official title: Study to Assess and Compare the Immunogenicity and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD's DTPa-HBV-IPV-Hib Vaccine (HEXAVAC™) Given at 3, 5 and 11-12 Months of Age
The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.
- Conditions
- Hepatitis B, Poliomyelitis, Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b
- Being tested
- DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA), DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)
- Keywords
- HEXAVACTM, InfanrixTM HEXA, DTPa-HBV-IPV-Hib, DTPa-HBV-IPV/Hib
- Medical subject headings
- Hepatitis B, Poliomyelitis, Diphtheria, Tetanus, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)Biological
Three doses administered intramuscularly
DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)Biological
Three doses administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| DTPa 1 Group | Experimental | Not described Receives: Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) |
| DTPa 2 Group | Active comparator | Not described Receives: Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations
Measured: Prior to the third primary vaccination dose ( Months 8-9)
Secondary outcomes (7)
Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations
Measured: One month after the second and third primary vaccination dose (Month 3 and Months 9-10)
Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected subjects defined by antibody concentration
Measured: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10)
Immunogenicity with respect to the components of the study vaccine in terms of number of seropositive subjects
Measured: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10)
Occurrence of solicited symptoms
Measured: Within 4 days (Day 0 -Day 3) after each vaccine dose
Occurrence of a grade "3" solicited symptoms
Measured: Within 4 days (Day 0 -Day 3) after each vaccine dose
Occurrence of unsolicited adverse events
Measured: Within 31 days after any vaccination
Occurrence of Serious Adverse Events
Measured: Throughout the entire study up to (Month 0 to Month 9-10) and including 30 days after last vaccination (Month 9-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 494 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
- NCT01457547
- Sponsor's protocol ID
- 217744/094
- Status last verified
- Aug 2016
- First submitted
- 13 Oct 2011
- Last updated
- 5 Aug 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.
Publications
Kilpi et al. Comparison of the immunogenicity and reactogenicity of two hexavalent DTPa-HBV-IPV/Haemophilus influenzae type b vaccines administered at 3, 5 and 11-12 months of age. Abstract presented at the 24th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel Switzerland 03-05 May, 2006.
Kilpi TM, Silfverdal SA, Nilsson L, Syrjanen R, Belloni C, Desole M, Triban C, Storsaeter J, Soila M, Jacquet JM. Immunogenicity and reactogenicity of two diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccines administered at 3, 5 and 11-12 months of age. Hum Vaccin. 2009 Jan-Feb;5(1):18-25. doi: 10.4161/hv.5.1.6369. Epub 2009 Jan 2.
PubMed 18690013Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.
PubMed 22349525
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess and Compare the Immunogenicity and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD's DTPa-HBV-IPV-Hib Vaccine (HEXAVAC™) Given at 3, 5 and 11-12 Months of Age
- ClinicalTrials.gov ID
- NCT01457547
- Acronym / sponsor ID
- 217744/094
- Conditions
- Hepatitis B, Poliomyelitis, Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b
- Keywords
- HEXAVACTM, InfanrixTM HEXA, DTPa-HBV-IPV-Hib, DTPa-HBV-IPV/Hib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 24 Oct 2011 (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.
The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTPa 1 Group | Experimental | Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) |
| DTPa 2 Group | Active comparator | Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) |
Who may qualify
- Ages
- 8 to 15 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a normal gestation period between 36 and 42 weeks.
Key exclusion criteria (10 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease.
- Planned administration of a vaccine not foreseen by the study protocol since birth and during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose of the three-dose primary vaccination course, with the exception of licensed Neisseria meningitides conjugate vaccines or Bacillus Calmette-Guérin (BCG) vaccine that can be given in between study visits or after the third visit, provided they are given preferably with a 4 weeks interval but not less than 3 weeks apart from the study vaccine doses.
- Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs since birth.
- Planned administration of immunoglobulins and/or any blood products since birth or planned administration during the period up to 30 days after the third dose of the primary vaccination course.
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 |
|---|---|---|
| DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)Three doses administered intramuscularly | Biological | DTPa 1 Group |
| DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)Three doses administered intramuscularly | Biological | DTPa 2 Group |
Primary outcome
Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations
Time frame: Prior to the third primary vaccination dose ( Months 8-9)
7 secondary outcomes
Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations
Time frame: One month after the second and third primary vaccination dose (Month 3 and Months 9-10)
Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected subjects defined by antibody concentration
Time frame: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10)
Immunogenicity with respect to the components of the study vaccine in terms of number of seropositive subjects
Time frame: Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10)
Occurrence of solicited symptoms
Time frame: Within 4 days (Day 0 -Day 3) after each vaccine dose
Occurrence of a grade "3" solicited symptoms
Time frame: Within 4 days (Day 0 -Day 3) after each vaccine dose
Occurrence of unsolicited adverse events
Time frame: Within 31 days after any vaccination
Occurrence of Serious Adverse Events
Time frame: Throughout the entire study up to (Month 0 to Month 9-10) and including 30 days after last vaccination (Month 9-10)
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 5 Aug 2016.
- BackgroundKilpi et al. Comparison of the immunogenicity and reactogenicity of two hexavalent DTPa-HBV-IPV/Haemophilus influenzae type b vaccines administered at 3, 5 and 11-12 months of age. Abstract presented at the 24th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel Switzerland 03-05 May, 2006.
- Background: PubMed 18690013Kilpi TM, Silfverdal SA, Nilsson L, Syrjanen R, Belloni C, Desole M, Triban C, Storsaeter J, Soila M, Jacquet JM. Immunogenicity and reactogenicity of two diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccines administered at 3, 5 and 11-12 months of age. Hum Vaccin. 2009 Jan-Feb;5(1):18-25. doi: 10.4161/hv.5.1.6369. Epub 2009 Jan 2.
- Background: PubMed 22349525Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.
- 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
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) in people with Hepatitis B and Poliomyelitis, run by GlaxoSmithKline at 9 sites in 3 countries.
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 4 inclusion and 10 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations (time frame: Prior to the third primary vaccination dose ( Months 8-9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01457547, which also lists 3 linked publications.
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 5 Aug 2016.