Back to resultsImmunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Primary Purpose
Acellular Pertussis, Tetanus, Diphtheria
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Infanrix+Hib™
Poliorix™
Sponsored by
About this trial
This is an interventional prevention trial for Acellular Pertussis focused on measuring combination vaccine, booster vaccination
Eligibility Criteria
Inclusion Criteria:
- A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Subjects who completed the full three-dose primary vaccination course in study NCT01086423.
- Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the 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 dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.
- Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.
- Serious chronic illness.
- Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
- Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.
- Encephalopathy
- Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
- Seizures with or without fever occurring within 3 days of vaccination.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Acute disease and/or fever at the time of enrolment.
Sites / Locations
- 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+HIB/POLIORIX 1 GROUP
INFANRIX+HIB/POLIORIX 2 GROUP
CONTROL GROUP
Arm Description
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Outcomes
Primary Outcome Measures
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Number of Seroprotected Subjects Against PRP
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Secondary Outcome Measures
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, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
Number of Subjects With Any 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)
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
NCT01449812
Brief Title
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Official Title
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2011 (undefined)
Primary Completion Date
January 16, 2012 (Actual)
Study Completion Date
January 16, 2012 (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 the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acellular Pertussis, Tetanus, Diphtheria, Haemophilus Influenzae Type b
Keywords
combination vaccine, booster vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
831 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INFANRIX+HIB/POLIORIX 1 GROUP
Arm Type
Experimental
Arm Description
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Arm Title
INFANRIX+HIB/POLIORIX 2 GROUP
Arm Type
Experimental
Arm Description
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
Intervention Type
Biological
Intervention Name(s)
Infanrix+Hib™
Other Intervention Name(s)
DTPa /Hib
Intervention Description
Intramuscular, one dose
Intervention Type
Biological
Intervention Name(s)
Poliorix™
Other Intervention Name(s)
IPV
Intervention Description
Intramuscular, one dose
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Description
A seroprotected subject was defined as a vaccinated 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 vaccination (At Day 0)
Title
Anti-D and Anti-T Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
Description
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame
Before the booster vaccination (At Day 0)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Description
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Time Frame
Before the booster vaccination (At Day 0)
Title
Anti-polio Type 1, 2 and 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Description
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Time Frame
Before the booster vaccination (At Day 0)
Title
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Description
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Description
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
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) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Time Frame
Before the booster vaccination (At Day 0)
Title
Anti-D and Anti-T Antibody Concentrations
Description
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/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 vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seroprotected Subjects Against PRP
Description
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
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) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame
Before the booster vaccination (At Day 0)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
Description
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Description
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Anti-polio Type 1, 2 and 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.
Time Frame
Before the booster vaccination (At Day 0)
Title
Anti-polio Type 1, 2 and 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Description
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Time Frame
Before the booster vaccination (At Day 0)
Title
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Description
A seropositive subject was defined as a vaccinated 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
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Time Frame
Before the booster vaccination (At Day 0)
Title
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Time Frame
One month after the booster vaccination (At Month 1)
Title
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Description
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Time Frame
One month after the booster vaccination (At Month 1)
Secondary Outcome Measure Information:
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) post-vaccination period
Title
Number of Subjects With Any Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With Any 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 (Days 0-30) post-vaccination period
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 (from Month 0 up to Month 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
Subjects who completed the full three-dose primary vaccination course in study NCT01086423.
Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Child in care
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the 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 dose.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.
Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.
Serious chronic illness.
Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.
Encephalopathy
Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
Collapse or shock-like state within 48 hours of vaccination.
Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
Seizures with or without fever occurring within 3 days of vaccination.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
Acute disease and/or fever at the time of enrolment.
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
Wuzhou
State/Province
Guangxi
ZIP/Postal Code
543002
Country
China
Facility Name
GSK Investigational Site
City
Wuzhou
State/Province
Guangxi
ZIP/Postal Code
543100
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
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