Hepatitis BPhase 3NCT01457560
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
A Phase 3 study testing DTPa-HBV-IPV/Hib (Infanrix hexa™) and OPV in people with Hepatitis B and Acellular Pertussis, run by GlaxoSmithKline.
Trial summary
This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. 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, Acellular Pertussis, Haemophilus Influenzae Type b
- What is being tested?
- DTPa-HBV-IPV/Hib (Infanrix hexa™) and OPV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Apr 2001
- 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
- The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.
- Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant 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 exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.
- 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.
Show all 12Show fewer
- 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.
- 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 the time of enrolment.
About this study
Official title: Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)
This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.
- Conditions
- Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis
- Being tested
- DTPa-HBV-IPV/Hib (Infanrix hexa™), OPV
- Keywords
- Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine
- Medical subject headings
- Hepatitis B, Haemophilus Infections, Diphtheria, Tetanus, Poliomyelitis
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
OPVBiological
One dose administered orally
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™); Biological: OPV |
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 values
Measured: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
Secondary outcomes (6)
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 values
Measured: Before the first dose ( Month 0 )
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Measured: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Measured: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Measured: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Number of subjects with solicited and unsolicited adverse events
Measured: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
Number of subjects with serious adverse events
Measured: During the study period (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 startFeb 2000
- Primary completionApr 2001
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT01457560
- Sponsor's protocol ID
- 217744/060
- Status last verified
- Aug 2016
- First submitted
- 20 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
Van 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 the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)
- ClinicalTrials.gov ID
- NCT01457560
- Acronym / sponsor ID
- 217744/060
- Conditions
- Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis
- Keywords
- Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Apr 2001 (actual)
- Study completion
- Apr 2001 (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 the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™), Biological: OPV |
Who may qualify
- Ages
- 12 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.
- Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant 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 exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.
- 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 |
| OPVOne dose administered orally | Biological | Group A |
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 values
Time frame: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
6 secondary outcomes
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 values
Time frame: Before the first dose ( Month 0 )
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Time frame: Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Time frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Time frame: One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Number of subjects with solicited and unsolicited adverse events
Time frame: After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
Number of subjects with serious adverse events
Time frame: During the study period (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 5 Aug 2016.
- 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.
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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™) and OPV in people with Hepatitis B and Acellular Pertussis, 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 4 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 5 Aug 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?
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 values (time frame: One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 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 NCT01457560, which also lists 1 linked publication.
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.