Hepatitis BPhase 4NCT00753649
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
A Phase 4 study testing Infanrix™ hexa in people with Hepatitis B and Tetanus, run by GlaxoSmithKline at 3 sites in Canada.
Trial summary
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Tetanus, Poliomyelitis
- What is being tested?
- Infanrix™ hexa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 3 sitesCanada
- Study dates
- 23 Sep 2008to 12 Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Healthy subjects as established by medical history before entering into the study.
- Written informed consent obtained from the parent or guardian of the subject.
Who cannot join
- Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose..
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Major congenital defects or serious chronic illness.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
Show all 10Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
GSK Investigational Site
Edmonton, Alberta, T5M 3Z7
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Vancouver, British Columbia, V5Z 4H4
About this study
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.
Read the detailed description
This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).
- Conditions
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Acellular Pertussis
- Being tested
- Infanrix™ hexa
- Keywords
- Infant, First nation, Aboriginal, Canada
- Medical subject headings
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix™ hexaBiological
Also called DTPa-HBV-IPV/Hib
Intramuscular, three doses
| Study group | Role | What they receive |
|---|---|---|
| Aboriginal infants group | Experimental | Not described Receives: Biological: Infanrix™ hexa |
| Other Non-Aboriginal infants | Active comparator | Not described Receives: Biological: Infanrix™ hexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Measured: One month after (POST) Dose 3.
Secondary outcomes (7)
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Measured: One month after (POST) Dose 3.
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
Measured: One month after (POST) Dose 3.
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)
A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
Measured: One month after (POST) Dose 3.
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Measured: One month after (POST) Dose 3.
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).
Measured: One month after (POST) Dose 3.
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31 day (Days 0-30) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period up to Last subject last visit on 03/12/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study start23 Sep 2008
- Primary completion12 Mar 2013
- Study completion12 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 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
- NCT00753649
- Sponsor's protocol ID
- 103506
- Other IDs
- 2013-003428-34
- Status last verified
- Nov 2019
- First submitted
- 12 Sep 2008
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Scheifele DW, Ferguson M, Predy G, Dawar M, Assudani D, Kuriyakose S, Van Der Meeren O, Han HH. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib vaccine in Canadian Aboriginal and non-Aboriginal infants. Vaccine. 2015 Apr 15;33(16):1897-900. doi: 10.1016/j.vaccine.2015.02.015. Epub 2015 Feb 18.
PubMed 25701314
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
- ClinicalTrials.gov ID
- NCT00753649
- Acronym / sponsor ID
- 103506
- Conditions
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Acellular Pertussis
- Keywords
- Infant, First nation, Aboriginal, Canada
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2008 (actual)
- Primary completion
- 12 Mar 2013 (actual)
- Study completion
- 12 Mar 2013 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Posted 30 Nov 2016
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 evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.
Detailed description
This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aboriginal infants group | Experimental | Biological: Infanrix™ hexa |
| Other Non-Aboriginal infants | Active comparator | Biological: Infanrix™ hexa |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Healthy subjects as established by medical history before entering into the study.
- Written informed consent obtained from the parent or guardian of the subject.
Key exclusion criteria (10 listed)
- Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose..
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Major congenital defects or serious chronic illness.
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 |
|---|---|---|
| Infanrix™ hexaAlso: DTPa-HBV-IPV/HibIntramuscular, three doses | Biological | Aboriginal infants group, Other Non-Aboriginal infants |
Primary outcome
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
Time frame: One month after (POST) Dose 3.
A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
7 secondary outcomes
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
Time frame: One month after (POST) Dose 3.
Anti-PRP Antibody Concentrations
Time frame: One month after (POST) Dose 3.
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)
Time frame: One month after (POST) Dose 3.
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
Time frame: One month after (POST) Dose 3.
Anti-HBs Antibody Concentrations
Time frame: One month after (POST) Dose 3.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31 day (Days 0-30) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period up to Last subject last visit on 03/12/2013
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25701314Scheifele DW, Ferguson M, Predy G, Dawar M, Assudani D, Kuriyakose S, Van Der Meeren O, Han HH. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib vaccine in Canadian Aboriginal and non-Aboriginal infants. Vaccine. 2015 Apr 15;33(16):1897-900. doi: 10.1016/j.vaccine.2015.02.015. Epub 2015 Feb 18.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infanrix™ hexa in people with Hepatitis B and Tetanus, run by GlaxoSmithKline at 3 sites in Canada.
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 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 30 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP) (time frame: One month after (POST) Dose 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 NCT00753649, 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 27 Nov 2019.