Back to resultsImmunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Primary Purpose
Acellular Pertussis, Diphtheria, Poliomyelitis
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Infanrix Hexa
Sponsored by
About this trial
This is an interventional prevention trial for Acellular Pertussis focused on measuring Hexavalent vaccine, Booster
Eligibility Criteria
Inclusion Criteria:
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
- A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
- Written informed consent obtained from the parent or guardian of the subject
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
INFANRIX HEXA PF GROUP
INFANRIX HEXA PC GROUP
CONTROL GROUP
Arm Description
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Outcomes
Primary Outcome Measures
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Number of Subjects With a Vaccine Response to PT, FHA and PR
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Secondary Outcome Measures
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.
Number of Seroprotected Subjects Against PT, FHA and PRN
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Number of Subjects With a Vaccine Response to PT, FHA and PR
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects Reporting Concomitant Medications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00627458
Brief Title
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Official Title
Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2008 (undefined)
Primary Completion Date
August 18, 2008 (Actual)
Study Completion Date
August 18, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
Detailed Description
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b, Tetanus, Hepatitis B
Keywords
Hexavalent vaccine, Booster
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INFANRIX HEXA PF GROUP
Arm Type
Experimental
Arm Description
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Arm Title
INFANRIX HEXA PC GROUP
Arm Type
Experimental
Arm Description
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Intervention Type
Biological
Intervention Name(s)
Infanrix Hexa
Other Intervention Name(s)
GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Intervention Description
Vaccine administered as a booster dose at 16-20 months of age
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Description
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
Before the booster administration (At Month 0)
Title
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Description
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Description
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time Frame
Before the booster vaccination (At Month 0)
Title
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Description
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Description
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time Frame
Before the booster vaccination (At Month 0)
Title
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Description
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Description
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame
Before the booster vaccination (At Month 0)
Title
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Description
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Description
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time Frame
Before the booster vaccination (At Month 0)
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Description
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Subjects With a Vaccine Response to PT, FHA and PR
Description
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).
Time Frame
One month after the booster vaccination (At Month 1)
Title
Anti-D and Anti-T Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame
Before the booster vaccination (At Month 0)
Title
Anti-D and Anti-T Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame
Before the booster vaccination (At Month 0)
Title
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Anti-HBs Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame
Before the booster vaccination (At Month 0)
Title
Anti-HBs Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
Before the booster vaccination (At Month 0)
Title
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
One month after the booster vaccination (At Month 1)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Time Frame
Before the booster vaccination (At Month 0)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Secondary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Description
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Description
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Description
A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Number of Seroprotected Subjects Against PT, FHA and PRN
Description
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Description
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Anti-D and Anti-T Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Anti-HBs Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time Frame
Before (Month 0) and one month after (Month 1) the booster vaccination
Title
Number of Subjects With a Vaccine Response to PT, FHA and PR
Description
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).
Time Frame
One month after the booster dose (At Month 1)
Title
Number of Subjects With Any Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During the 4-day (Days 0-3) follow-up period after the booster vaccination
Title
Number of Subjects With Any Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During the 4-day (Days 0-3) follow-up period after the booster vaccination
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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
During the 31-day (Day 0-30) follow-up period after the booster vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From Month 0 to Month 1, during the entire study period
Title
Number of Subjects Reporting Concomitant Medications
Time Frame
During the 4-day (Days 0-3) follow-up period after the booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
20 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
Written informed consent obtained from the parent or guardian of the subject
Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
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
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111344
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111344
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111344
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111344
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111344
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111344
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111344
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
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