Hepatitis BPhase 2NCT01457495
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
A Phase 2 study testing DTPa-HBV-IPV/Hib (Infanrix-hexa™), DTPa-IPV/Hib (Infanrix-IPV/Hib™) and HBV (Engerix™-B) in people with Hepatitis B and Diphtheria, run by GlaxoSmithKline.
Trial summary
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 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-IPV/Hib (Infanrix-IPV/Hib™) and HBV (Engerix™-B)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to Sep 1999
- Phase
- Phase 2
- 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 between 12 and 16 weeks 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
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
- Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
- History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
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- History of allergic disease or reaction 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.
- Progressive neurological disorders.
- Administration of immunoglobulins and/or any blood products since birth and during the study period.
- Acute febrile illness at the time of planned vaccination.
About this study
Official title: Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis, Pertussis, Tetanus
- Being tested
- DTPa-HBV-IPV/Hib (Infanrix-hexa™), DTPa-IPV/Hib (Infanrix-IPV/Hib™), HBV (Engerix™-B)
- Keywords
- Infants, combined vaccine, DTPa-HBV-IPV/Hib, DTPa-IPV/Hib, safety, Immunogenicity, HBV
- 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
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
DTPa-IPV/Hib (Infanrix-IPV/Hib™)Biological
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
HBV (Engerix™-B)Biological
3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8
| Study group | Role | What they receive |
|---|---|---|
| DTPa 1 Group | Experimental | Not described Receives: Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™) |
| DTPa 2 Group | Active comparator | Not described Receives: Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™); Biological: HBV (Engerix™-B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with antibody titers equal to or greater than cut-off value.
Measured: One month after the 2nd dose of the primary vaccination course (month 3)
Secondary outcomes (7)
Immunogenicity with respect to 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 (Months 8 and 9)
Immunogenicity with respect to components of the study vaccines in terms of antibody titers
Measured: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)
Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response
Measured: One month after the 3rd dose of the primary vaccination course (Month 9)
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 AEs
Measured: Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination
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 startSep 1998
- Primary completionSep 1999
- Study completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 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
- NCT01457495
- Sponsor's protocol ID
- 217744/031
- Status last verified
- Jun 2017
- First submitted
- 13 Oct 2011
- Last updated
- 16 Jun 2017
- Results posted
- No
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 Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites
- ClinicalTrials.gov ID
- NCT01457495
- Acronym / sponsor ID
- 217744/031
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis, Pertussis, Tetanus
- Keywords
- Infants, combined vaccine, DTPa-HBV-IPV/Hib, DTPa-IPV/Hib, safety, Immunogenicity, HBV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 1998
- Primary completion
- Sep 1999 (actual)
- Study completion
- Sep 1999 (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 of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 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 |
|---|---|---|
| DTPa 1 Group | Experimental | Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™) |
| DTPa 2 Group | Active comparator | Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™), Biological: HBV (Engerix™-B) |
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 between 12 and 16 weeks 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 (11 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
- Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
- History of/or intercurrent 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™)3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8 | Biological | DTPa 1 Group |
| DTPa-IPV/Hib (Infanrix-IPV/Hib™)3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8 | Biological | DTPa 2 Group |
| HBV (Engerix™-B)3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8 | Biological | DTPa 2 Group |
Primary outcome
Number of subjects with antibody titers equal to or greater than cut-off value.
Time frame: One month after the 2nd dose of the primary vaccination course (month 3)
7 secondary outcomes
Immunogenicity with respect to 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 (Months 8 and 9)
Immunogenicity with respect to components of the study vaccines in terms of antibody titers
Time frame: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9)
Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response
Time frame: One month after the 3rd dose of the primary vaccination course (Month 9)
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 AEs
Time frame: Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination
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.
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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 2 study testing DTPa-HBV-IPV/Hib (Infanrix-hexa™), DTPa-IPV/Hib (Infanrix-IPV/Hib™) and HBV (Engerix™-B) 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 11 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of subjects with antibody titers equal to or greater than 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?
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.