Back to resultsImmunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Primary Purpose
Hepatitis B, Tetanus, Poliomyelitis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Infanrix™ hexa
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Infant, First nation, Aboriginal, Canada
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aboriginal infants group
Other Non-Aboriginal infants
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
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.
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00753649
Brief Title
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Official Title
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 23, 2008 (Actual)
Primary Completion Date
March 12, 2013 (Actual)
Study Completion Date
March 12, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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.
Detailed Description
This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Acellular Pertussis
Keywords
Infant, First nation, Aboriginal, Canada
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aboriginal infants group
Arm Type
Experimental
Arm Title
Other Non-Aboriginal infants
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Infanrix™ hexa
Other Intervention Name(s)
DTPa-HBV-IPV/Hib
Intervention Description
Intramuscular, three doses
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
Description
A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Time Frame
One month after (POST) Dose 3.
Secondary Outcome Measure Information:
Title
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
Description
For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Time Frame
One month after (POST) Dose 3.
Title
Anti-PRP Antibody Concentrations
Description
Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
Time Frame
One month after (POST) Dose 3.
Title
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)
Description
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.
Time Frame
One month after (POST) Dose 3.
Title
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
Description
The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Time Frame
One month after (POST) Dose 3.
Title
Anti-HBs Antibody Concentrations
Description
Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).
Time Frame
One month after (POST) Dose 3.
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 31 day (Days 0-30) post vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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.
Time Frame
During the entire study period up to Last subject last visit on 03/12/2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 3Z7
Country
Canada
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4H4
Country
Canada
Facility Name
GSK Investigational Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/Posting.aspx?ID=19621
Citations:
PubMed Identifier
25701314
Citation
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.
Results Reference
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Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
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