Back to resultsImmunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
Primary Purpose
Tetanus, Poliomyelitis, Acellular Pertussis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Infanrix-IPV/Hib™
Infanrix Hib™
Poliorix™
Sponsored by
About this trial
This is an interventional prevention trial for Tetanus focused on measuring Infanrix-IPV+Hib
Eligibility Criteria
Inclusion Criteria:
- A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
- Born after a gestation period of 36 to 42 weeks, inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s) or LAR(s) 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 other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Child in care.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
- 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.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Haemophilus influenzae type b (Hib) disease or vaccination.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
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 > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.
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-IPV+HIB 1 GROUP
INFANRIX-IPV+HIB 2 GROUP
INFANRIX-HIB+POLIORIX GROUP
Arm Description
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Outcomes
Primary Outcome Measures
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
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 Polyribosyl-ribitol-phosphate (PRP) Antigen
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens
A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Vaccine response was defined as:
For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.
For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.
Secondary Outcome Measures
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Anti-polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
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 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.
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)
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
NCT01086423
Brief Title
Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
Official Title
Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2010 (undefined)
Primary Completion Date
November 19, 2010 (Actual)
Study Completion Date
November 19, 2010 (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 the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Poliomyelitis, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
Keywords
Infanrix-IPV+Hib
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
985 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INFANRIX-IPV+HIB 1 GROUP
Arm Type
Experimental
Arm Description
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
Arm Title
INFANRIX-IPV+HIB 2 GROUP
Arm Type
Experimental
Arm Description
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
Arm Title
INFANRIX-HIB+POLIORIX GROUP
Arm Type
Active Comparator
Arm Description
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Intervention Type
Biological
Intervention Name(s)
Infanrix-IPV/Hib™
Intervention Description
Intramuscular, three doses
Intervention Type
Biological
Intervention Name(s)
Infanrix Hib™
Intervention Description
Intramuscular, three doses
Intervention Type
Biological
Intervention Name(s)
Poliorix™
Intervention Description
Intramuscular, three doses
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
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
One month after the third vaccine dose (Month 3 or Month 4)
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen
Description
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
Time Frame
One month after the third vaccine dose (Month 3 or Month 4)
Title
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens
Description
A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
Time Frame
One month after the third vaccine dose (Month 3 or Month 4)
Title
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Description
Vaccine response was defined as:
For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.
For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.
Time Frame
One month after the third vaccine dose (Month 3 or Month 4)
Secondary Outcome Measure Information:
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 first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time Frame
Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Title
Anti-polio Types 1, 2 and 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
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 (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
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 after each vaccine dose and across doses
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 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.
Time Frame
During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
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 (Days 0-30) post-vaccination period after any dose
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 to Month 4/5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
Born after a gestation period of 36 to 42 weeks, inclusive.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s) or LAR(s) 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 other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Child in care.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
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.
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Haemophilus influenzae type b (Hib) disease or vaccination.
History of seizures or progressive neurological disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
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 > 37.0°C 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
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 GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
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