Hepatitis BPhase 3NCT01457508
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
A Phase 3 study testing DTPa-HBV-IPV/Hib (Infanrix hexa™), DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) in people with Hepatitis B and Diphtheria, run by GlaxoSmithKline.
Trial summary
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age. Read more about this study
- Who is it for?
- Ages 12 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib)
- What is being tested?
- DTPa-HBV-IPV/Hib (Infanrix hexa™), DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Mar 2000
- 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 12 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female 3 months of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Who cannot join
- The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:
- 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.
- Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
- Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
- History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
- Major congenital defects or serious chronic illness.
- History of seizures or of any neurological disease at study entry.
- Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
- Acute disease at time of enrolment
About this study
Official title: Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis, Pertussis, Tetanus
- Being tested
- DTPa-HBV-IPV/Hib (Infanrix hexa™), DTPa-HBV-IPV (Infanrix penta™), Hib (Hiberix™)
- Keywords
- combination vaccine, DTPa-HBV-IPV, Hib
- Medical subject headings
- Hepatitis B, Diphtheria, Haemophilus Infections, Poliomyelitis, Whooping Cough, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPa-HBV-IPV/Hib (Infanrix hexa™)Biological
Three doses administered intramuscularly
DTPa-HBV-IPV (Infanrix penta™)Biological
Three doses administered intramuscularly
Hib (Hiberix™)Biological
Three doses administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine. Receives: Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™) |
| Group B | Active comparator | Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine. Receives: Biological: DTPa-HBV-IPV (Infanrix penta™); Biological: Hib (Hiberix™) |
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 number of subjects with antibody titres greater than or equal to cut off value
Measured: One month after the 2nd dose of the primary vaccination course ( Month 3)
Secondary outcomes (8)
Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects
Measured: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of number of seropositive subjects
Measured: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of antibody titres
Measured: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of vaccine response
Measured: One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3)
Occurrence of solicited local symptoms
Measured: Within 4 days after each vaccination and overall
Occurrence of solicited general symptoms
Measured: Within 4 days after each vaccination and overall
Occurrence of unsolicited symptoms
Measured: Within 30 days after each vaccination and overall
Occurrence of serious adverse events
Measured: Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9)
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 startJan 1999
- Primary completionMar 2000
- Study completionMar 2000
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 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
- NCT01457508
- Sponsor's protocol ID
- 217744/054
- Status last verified
- Jun 2017
- First submitted
- 20 Oct 2011
- Last updated
- 16 Jun 2017
- Results posted
- No
Publications
Crovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.
Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92. doi: 10.1080/00365540410017572.
PubMed 15370670Van 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 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately
- ClinicalTrials.gov ID
- NCT01457508
- Acronym / sponsor ID
- 217744/054
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis, Pertussis, Tetanus
- Keywords
- combination vaccine, DTPa-HBV-IPV, Hib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Mar 2000 (actual)
- Study completion
- Mar 2000 (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.
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine. |
| Group B | Active comparator | Biological: DTPa-HBV-IPV (Infanrix penta™), Biological: Hib (Hiberix™)Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine. |
Who may qualify
- Ages
- 12 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A male or female 3 months of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Key exclusion criteria (12 listed)
- The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:
- 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.
- Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
- Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
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 (Infanrix hexa™)Three doses administered intramuscularly | Biological | Group A |
| DTPa-HBV-IPV (Infanrix penta™)Three doses administered intramuscularly | Biological | Group B |
| Hib (Hiberix™)Three doses administered intramuscularly | Biological | Group B |
Primary outcome
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value
Time frame: One month after the 2nd dose of the primary vaccination course ( Month 3)
8 secondary outcomes
Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects
Time frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of number of seropositive subjects
Time frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of antibody titres
Time frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9)
Immunogenicity with respect to the components of the study vaccines in terms of vaccine response
Time frame: One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3)
Occurrence of solicited local symptoms
Time frame: Within 4 days after each vaccination and overall
Occurrence of solicited general symptoms
Time frame: Within 4 days after each vaccination and overall
Occurrence of unsolicited symptoms
Time frame: Within 30 days after each vaccination and overall
Occurrence of serious adverse events
Time frame: Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9)
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 16 Jun 2017.
- BackgroundCrovari P. et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.
- Background: PubMed 15370670Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92. doi: 10.1080/00365540410017572.
- Derived from this study: 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.
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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 DTPa-HBV-IPV/Hib (Infanrix hexa™), DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) in people with Hepatitis B and Diphtheria, 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 3 inclusion and 12 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 16 Jun 2017. 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?
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value (time frame: One month after the 2nd dose of the primary vaccination course ( Month 3)). 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 NCT01457508, 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 16 Jun 2017.